Sie sind auf Seite 1von 328

ASME BPE-2014

(Revision of ASME BPE-2012)

Bioprocessing
Equipment

A N I N T E R N AT I O N A L STA N DA R D

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
Copyright c 2014 by the American Society of Mechanical Engineers.
No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014
(Revision of ASME BPE-2012)

Bioprocessing
Equipment

A N I N T E R N AT I O N A L S TA N D A R D

Two Park Avenue New York, NY 10016 USA

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
Date of Issuance: October 10, 2014

The next edition of this Standard is scheduled for publication in 2016. This Standard will become
effective 6 months after the Date of Issuance.

ASME issues written replies to inquiries concerning interpretations of technical aspects of this
Standard. Periodically, certain actions of the ASME BPE Committee may be published as Cases.
Cases and interpretations are published on the ASME Web site under the Committee Pages at
http://cstools.asme.org/ as they are issued.

Errata to codes and standards may be posted on the ASME Web site under the Committee Pages to
provide corrections to incorrectly published items, or to correct typographical or grammatical errors
in codes and standards. Such errata shall be used on the date posted.

The Committee Pages can be found at http://cstools.asme.org/. There is an option available to


automatically receive an e-mail notification when errata are posted to a particular code or standard.
This option can be found on the appropriate Committee Page after selecting Errata in the Publication
Information section.

ASME is the registered trademark of The American Society of Mechanical Engineers.

This code or standard was developed under procedures accredited as meeting the criteria for American National
Standards. The Standards Committee that approved the code or standard was balanced to assure that individuals from
competent and concerned interests have had an opportunity to participate. The proposed code or standard was made
available for public review and comment that provides an opportunity for additional public input from industry, academia,
regulatory agencies, and the public-at-large.
ASME does not approve, rate, or endorse any item, construction, proprietary device, or activity.
ASME does not take any position with respect to the validity of any patent rights asserted in connection with any
items mentioned in this document, and does not undertake to insure anyone utilizing a standard against liability for
infringement of any applicable letters patent, nor assume any such liability. Users of a code or standard are expressly
advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, is
entirely their own responsibility.
Participation by federal agency representative(s) or person(s) affiliated with industry is not to be interpreted as
government or industry endorsement of this code or standard.
ASME accepts responsibility for only those interpretations of this document issued in accordance with the established
ASME procedures and policies, which precludes the issuance of interpretations by individuals.

No part of this document may be reproduced in any form,


in an electronic retrieval system or otherwise,
without the prior written permission of the publisher.

The American Society of Mechanical Engineers


Two Park Avenue, New York, NY 10016-5990

Copyright 2014 by
THE AMERICAN SOCIETY OF MECHANICAL ENGINEERS
All rights reserved
Printed in U.S.A.

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
CONTENTS

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Statements of Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Committee Roster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
Summary of Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvi
Part GR General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
GR-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
GR-2 Scope of the ASME BPE Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
GR-3 Manufacturers Quality Assurance Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
GR-4 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
GR-5 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
GR-6 U.S. Customary and SI Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
GR-7 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
GR-8 Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Part SD Systems Design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
SD-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
SD-2 General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
SD-3 Process Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
SD-4 Process Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
SD-5 Process Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
SD-6 Design Conformance Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Part DT Dimensions and Tolerances for Process Components. . . . . . . . . . . . . . . . . . . . . . . . 90
DT-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
DT-2 Pressure Rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
DT-3 Wall Thickness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
DT-4 Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
DT-5 Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
DT-6 Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
DT-7 Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
DT-8 Weld Ends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
DT-9 Hygienic Clamp Unions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
DT-10 Minimum Examination Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
DT-11 Marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
DT-12 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Part MJ Materials Joining. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
MJ-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
MJ-2 Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
MJ-3 Joint Design and Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
MJ-4 Joining Processes and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
MJ-5 Procedure Qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
MJ-6 Performance Qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
MJ-7 Examination, Inspection, and Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
MJ-8 Acceptance Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
MJ-9 Joining of Polymeric Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
MJ-10 Documentation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
MJ-11 Passivation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Part SF Process Contact Surface Finishes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
SF-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

iii

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
SF-2 Metallic Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
SF-3 Polymeric Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Part SG Sealing Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
SG-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
SG-2 Sealing Component Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
SG-3 Sealing Components General Design Requirements (General
Provisions) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
SG-4 Seal Performance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
SG-5 Seal Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Part PM Polymeric and Other Nonmetallic Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
PM-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
PM-2 Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
PM-3 Properties and Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
PM-4 Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Part CR Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
CR-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
CR-2 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
Part MM Metallic Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
MM-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
MM-2 Alloy Designations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
MM-3 Uses of Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
MM-4 Referenced Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
MM-5 Fabrication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
MM-6 Mechanical Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
MM-7 Corrosion Resistance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
MM-8 Addition of New Alloys to Part MM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
Part PI Process Instrumentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
PI-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
PI-2 Process Instrumentation General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . 199
PI-3 Instrument Receiving, Handling, and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200
PI-4 Flowmeters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200
PI-5 Level Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
PI-6 Pressure Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
PI-7 Temperature Sensors and Associated Components . . . . . . . . . . . . . . . . . . . . . . . 205
PI-8 Analytical Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211
PI-9 Optical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
Figures
SD-3.1.1-1 Flat Gasket Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
SD-3.1.2.2-1 Accepted Point-of-Use Designs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
SD-3.2.1-1 Flexible Hygienic Hose Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
SD-3.3.2.2-1 Pump Impeller Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
SD-3.3.2.2-2 Acceptable Impeller Attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
SD-3.3.2.2-3 Casing Drain Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
SD-3.3.2.2-4 Casing Drain L/D Ratios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
SD-3.4.2-1 Nozzle Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
SD-3.4.2-2 Side and Bottom Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
SD-3.4.2-3 Sidewall Instrument Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
SD-3.4.2-4 Accepted Nozzle Penetrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
SD-3.4.2-5 Vessel Design Tangential Nozzles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
SD-3.4.2-6 Sight Glass Design (Accepted) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
SD-3.4.2-7 Typical Nozzle Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
SD-3.4.3-1 Internal Support Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

iv

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
SD-3.5.1-1 Agitator Mounting Flanges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
SD-3.5.2-1 Shaft Coupling Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
SD-3.5.2-2 Shaft Coupling Seal Arrangments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
SD-3.5.2-3 Fastener Seal Arrangements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
SD-3.5.5-1 Shaft Steady Bearing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount) . . . . . . . . . . . . . . . . . . . . 45
SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design . . . . . . . . . . . . . . . . . . . . . . . 46
SD-3.7.1-1 Transfer Panel Looped Headers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
SD-3.7.2-1 Transfer Panel Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
SD-3.7.4-1 Transfer Panel Jumpers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
SD-3.8.1.1-1 Tapered Locking Tab Retainer Recessed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
SD-3.8.1.1-2 Tapered Locking Tab Retainer External . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
SD-3.9.1-1 Dynamic Spray Device: Single Axis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
SD-3.9.1-2 Two Axes Dynamic Spray Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
SD-3.9.2.1-1 Static Spray Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
SD-3.9.2.1-2 Flow Rate Guideline for Vertical Cylindrical Vessels . . . . . . . . . . . . . . . . . . . . . 56
SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels . . . . . . . . . . . . . . . . . . 57
SD-3.9.2.3-1 Impact Pattern Build-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
SD-3.12-1 Steam Traps for Clean Steam Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
SD-4.1.2.1-1 Point-of-Use Piping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
SD-4.1.2.2-1 Physical Break in Point-of-Use Piping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
SD-4.2.2-1 Typical Clean Steam System Isometric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
SD-4.2.2-2 Clean Steam Point-of-Use Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
SD-5.1.1.1-1 Fermentor Sterile Envelope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
SD-5.1.1.1-2 Bioreactor Sterile Envelope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
SD-5.1.1.2.3-1 Gas Sparging Assembly Lance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
SD-5.1.1.2.3-2 Gas Sparging Assembly Sintered . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
SD-5.1.1.2.3-3 Gas Sparging Assembly Ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
SD-5.1.1.2.3-4 Gas Sparging Assembly Single Orifice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
SD-5.1.1.3.1-1 Exhaust Gas Condenser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
SD-5.1.1.3.1-2 Exhaust Gas Heater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
SD-5.1.1.3.1-3 Electrically Heat Traced Filter Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
SD-5.2.1.1-1 Tank/Vessel Vent Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
SD-5.3.3.5.1-1 CIP Looped Header (Supply or Return) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
SD-5.3.3.5.1-2 Zero-Static Chain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
SD-5.3.3.5.1-3 Swing Elbow Arrangement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
SD-5.4.1.2-1 Typical Lyophilizer Component Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
SD-5.4.1.3-1 Lyophilizer Sterile Boundary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
DT-2-1 Clamp Conditions at Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Tube Welds . . . . . . . . . . . . . . 132
MJ-8.4-2 Discoloration Acceptance Criteria for Weld Heat-Affected Zones on
Electropolished 316L Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
MJ-8.4-3 Discoloration Acceptance Criteria for Weld Heat-Affected Zones on
Mechanically Polished 316L Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
MJ-8.4-4 Acceptable and Unacceptable Weld Bend Width and Meander . . . . . . . . . . . 135
MJ-8.5-1 Acceptable Weld Profiles for Tube-Attachment Fillet Welds . . . . . . . . . . . . . . 138
MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Beadless Welds . . . . . . . . . . 139
SG-2.2.2-1 Hygienic Union per Table DT-7-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
SG-2.2.2-2 Hygienic Clamp Union per Table DT-7-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
SG-2.2.2-3 Hygienic Union per DIN 11864 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
SG-2.2.2-4 Hygienic Clamp Union per DIN 11864 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
SG-2.2.2-5 Nonhygienic Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
SG-2.3.1.2-1 Weir Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
SG-2.3.1.2-2 Radial Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
SG-2.3.1.2-3 Weirless Diaphragm Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
SG-2.3.1.2-4 Linear Control Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
SG-2.3.1.2-5 Regulator Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
SG-2.3.1.3-1 Ball Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
SG-2.3.1.4-1 Rising Stem Single, Double Seat Mix Proof, and Needle Valves . . . . . . . . . . . 152
SG-2.3.1.5-1 Butterfly Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
SG-2.3.1.7-1 Back Pressure Control Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
SG-2.3.1.8-1 Pinch Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
SG-2.3.1.9-1 Pressure Relief and Check Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
SG-2.3.1.10-1 Plug Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
SG-2.3.2.2-1 Single Mechanical Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
SG-2.3.2.2-2 Single Seal for Top Entry Agitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
SG-2.3.2.3-1 Dual Pressurized Mechanical Seal for Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
SG-2.3.2.3-2 Dual Pressurized Mechanical Seal for Top Entry Agitator . . . . . . . . . . . . . . . . 156
SG-2.3.2.3-3 Dual Unpressurized Mechanical Seal for Pumps . . . . . . . . . . . . . . . . . . . . . . . . . 157
SG-2.3.2.4-1 Flush Plan 01 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
SG-2.3.2.4-2 Flush Plan 02 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
SG-2.3.2.4-3 Flush Plan 03 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
SG-2.3.2.4-4 Flush Plan 11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
SG-2.3.2.4-5 Flush Plan 32 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
SG-2.3.2.4-6 Flush Plan 52 for Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
SG-2.3.2.4-7 Flush Plan 52 for Top Entry Agitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
SG-2.3.2.4-8 Flush Plan BPE52 for Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
SG-2.3.2.4-9 Flush Plan 53 for Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
SG-2.3.2.4-10 Flush Plan 53 for Top Entry Agitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
SG-2.3.2.4-11 Flush Plan 54 for Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
SG-2.3.2.4-12 Flush Plan 54 for Top Entry Agitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
SG-2.3.2.4-13 Flush Plan 55 for Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
SG-2.3.2.4-14 Flush Plan 55 for Top Entry Agitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
SG-2.3.2.4-15 Flush Plan 74 for Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
SG-2.3.2.4-16 Flush Plan 74 for Top Entry Agitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
SG-3.3.2.2-1 Static O-Ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
SG-3.3.2.3-1 Seals for Rising Stem Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
SG-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion . . . . . . . . . . . . . . 168
CR-1-1 ASME Certification Mark With BPE Designator . . . . . . . . . . . . . . . . . . . . . . . . . . 182
CR-2-1 Options for Certification of Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples . . . . . . . . . . . . . . . . . . . 200
PI-2.2.2-1 Accepted Insertion Device Installation Examples . . . . . . . . . . . . . . . . . . . . . . . . 201
PI-4.1.3.2-1 Manifold or Flow Splitter for Dual Tube Construction Flowmeters and
Potential for Product Holdup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
PI-4.1.3.3-1 Concentrically Reducing Process Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
PI-4.1.4.3-1 Vertical Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
PI-4.1.4.4-1 Minimum Angle of Inclination,  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
PI-5.1.2.1-1 Bulb, Horn, Isolated Horn, and Rod Style Antenna . . . . . . . . . . . . . . . . . . . . . . 205
PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location . . . . . . . . . . . . . . . . . . 206
PI-7.3-1 Typical Installation Styles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions . . . . . . . . . . . . . . . . . . . . . . . 208
PI-7.3.4-2 Accepted Nonintrusive Orientations and Flow Directions . . . . . . . . . . . . . . . . 208
PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations . . . . . . . . . . . . . . . . . . . . . . . . . 211
PI-8.1.2-1 Conductivity Type Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
PI-8.1.3-1 Accepted Installations for Conductivity Sensors . . . . . . . . . . . . . . . . . . . . . . . . . 213
PI-8.1.3.6-1 Installation Clearance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
PI-8.2.2-1 pH Sensor Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
PI-8.2.3-1 Accepted pH Sensor Installations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216
PI-8.2.3.4-1 Accepted Mounting Orientations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217
PI-8.2.3.5-1 Insertion Length or Depth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
PI-9.1.3.3-1 Vessel Light Glass Design and Mounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220

vi

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
PI-9.1.3.5-1 In-Line Insertion Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
PI-9.1.3.5-2 Insertion Probe Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
Tables
GR-4.2-1 Inspectors Delegate Capabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
SD-2.4.3.1-1 Slope Designations for Gravity-Drained Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
SD-3.1.2.2-1 L/D Dimensions for Flow-Through Tee: Full-Size Standard Straight
Tee With Blind Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
SD-3.1.2.2-2 L/D Dimensions for Flow-Through Tee: Short Outlet Reducing Tee With
Blind Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
SD-3.4.2-1 Annular Spacing Recommendations for Hygienic Dip Tubes . . . . . . . . . . . . . 34
SD-5.3.3.3-1 Flow Rates to Achieve 5 ft/sec (1.52 m/s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
DT-2-1 Hygienic Unions: Rated Internal Working Pressure . . . . . . . . . . . . . . . . . . . . . . 95
DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process
Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
DT-3-2 Final Tolerances for Electropolished Fittings and Process Components . . . . 97
DT-4-1 Nominal O.D. Tubing Sizes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
DT-4.1-1 Tangent Lengths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
DT-4.1.1-1 Automatic Tube Weld: 90-deg Elbow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
DT-4.1.1-2 Automatic Tube Weld: Hygienic Clamp Joint, 90-deg Elbow . . . . . . . . . . . . . . 98
DT-4.1.1-3 Hygienic Clamp Joint: 90-deg Elbow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
DT-4.1.1-4 Automatic Tube Weld: 45-deg Elbow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
DT-4.1.1-5 Automatic Tube Weld: Hygienic Clamp Joint, 45-deg Elbow . . . . . . . . . . . . . . 100
DT-4.1.1-6 Hygienic Clamp Joint: 45-deg Elbow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
DT-4.1.1-7 Automatic Tube Weld: 180-deg Return Bend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
DT-4.1.1-8 Hygienic Clamp Joint: 180-deg Return Bend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
DT-4.1.2-1 Automatic Tube Weld: Straight Tee and Cross . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
DT-4.1.2-2 Automatic Tube Weld: Short Outlet Hygienic Clamp Joint Tee . . . . . . . . . . . . 102
DT-4.1.2-3 Hygienic Mechanical Joint: Short Outlet Run Tee . . . . . . . . . . . . . . . . . . . . . . . . 103
DT-4.1.2-4 Hygienic Clamp Joint: Straight Tee and Cross . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
DT-4.1.2-5 Hygienic Clamp Joint: Short Outlet Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
DT-4.1.2-6 Automatic Tube Weld: Reducing Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
DT-4.1.2-7 Automatic Tube Weld: Short Outlet Hygienic Clamp, Joint
Reducing Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
DT-4.1.2-9 Hygienic Clamp Joint: Short Outlet Reducing Tee . . . . . . . . . . . . . . . . . . . . . . . . 107
DT-4.1.2-10 Automatic Tube Weld: Instrument Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
DT-4.1.2-11 Hygienic Clamp Joint: Instrument Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer . . . . . . . . . . . . . . . . . 108
DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer . . . . . . 109
DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer . . . . . . . . . . . . . . . . . 110
DT-4.1.4-1 Automatic Tube Weld: Ferrule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
DT-4.1.5-1 Automatic Tube Weld: Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
DT-4.4.1-1 Hygienic Clamp Joint: Weir Style Diaphragm Valve . . . . . . . . . . . . . . . . . . . . . . 113
DT-7-1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances . . . . . . . . . . . 114
DT-7-2 Transfer Panel and Jumper Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
MJ-6.3-1 Tube/Pipe Diameter Limits for Orbital GTAW Performance
Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
MJ-6.3-2 Weld Thickness Limits for Orbital GTAW Performance Qualification . . . . . 120
MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Pressure Vessels
and Tanks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Pipe . . . . . . . . . . . . . . . 128
MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on
Tube-to-Tube Butt Joints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
MJ-8.5-1 Visual Examination Acceptance Criteria for Tube-Attachment Welds . . . . . 136

vii

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
SF-2.2-1 Acceptance Criteria for Metallic Process Contact Surface Finishes . . . . . . . . 141
SF-2.2-2 Additional Acceptance Criteria for Electropolished Metallic Process
Contact Surface Finishes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
SF-2.4-1 Ra Readings for Metallic Process Contact Surfaces . . . . . . . . . . . . . . . . . . . . . . . 142
SF-2.6-1 Acceptance Criteria for Metallic Passivated Process Contact Surface
Finishes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
SF-3.3-1 Acceptance Criteria for Polymeric Process Contact Surface Finishes . . . . . . 144
SF-3.4-1 Ra Readings for Polymeric Process Contact Surfaces . . . . . . . . . . . . . . . . . . . . . . 144
PM-2.1.1-1 Common Thermoplastic Polymers and Applications . . . . . . . . . . . . . . . . . . . . . 171
PM-2.1.2-1 Common Thermoset Polymers and Applications . . . . . . . . . . . . . . . . . . . . . . . . . 171
PM-2.1.3-1 Examples of Nonmetallics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
PM-2.2.1-1 Content Required on the Certificate of Compliance . . . . . . . . . . . . . . . . . . . . . . 173
PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards . . . . . . . . . . . 177
MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %) . . . . . . . . . . . . . . . . 188
MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %) . . . . . . . . . . . . . . . . . . 189
MM-2.1-3 Stainless Steel and Nickel Alloy Cast Designations . . . . . . . . . . . . . . . . . . . . . . 190
MM-2.1-4 Wrought Copper: Nominal Compositions (wt. %) (Cleaned for Oxygen
Service) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
MM-5.1.2-1 Filler Metals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
MM-5.1.2-2 Consumable Inserts for Superaustenitic and Duplex Stainless Steels . . . . . . 196
MM-5.1.4-1 Predicted Ferrite Number (FN) Ranges for Various 316 Product Forms
and Welds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
MM-5.1.5-1 Materials for OEM Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
MM-5.2.5-1 Brazing Filler Metals for Copper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

Mandatory Appendices
I Submittal of Technical Inquiries to the Bioprocessing Equipment
(BPE) Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
II Standard Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

Nonmandatory Appendices
A Commentary: Slag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
B Material and Weld Examination/Inspection Documentation . . . . . . . . . . . . . . 227
C Slope Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
D Rouge and Stainless Steel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
E Passivation Procedure Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
F Corrosion Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
G Ferrite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254
H Electropolishing Procedure Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255
I Vendor Documentation Requirements for New Instruments . . . . . . . . . . . . . . 257
J Standard Process Test Conditions (SPTC) for Seal Performance
Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261
K Standard Test Methods for Polymers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271
L Spray Device Coverage Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274
M Commentary: 316L Weld Heat-Affected Zone Discoloration Acceptance
Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276
N Guidance When Choosing Polymeric and Nonmetallic Materials . . . . . . . . . 277
O General Background/Useful Information for Extractables and
Leachables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
P Temperature Sensors and Associated Components . . . . . . . . . . . . . . . . . . . . . . . 279
Q Instrument Receiving, Handling, and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281
R Application Data Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282
S Polymer Applications: Chromatography Columns . . . . . . . . . . . . . . . . . . . . . . . 285
T Guidance for the Use of U.S. Customary and SI Units . . . . . . . . . . . . . . . . . . . 286

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 289

viii

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
FOREWORD

At the 1988 ASME Winter Annual Meeting (WAM), many individuals expressed interest in
developing standards for the design of equipment and components for use in the biopharmaceuti-
cal industry. As a result of this interest, the ASME Council on Codes and Standards (CCS) was
petitioned to approve this as a project. The initial scope was approved by the CCS on June 20,
1989, with a directive to the Board on Pressure Technology to initiate this project with the following
initial scope:
This standard is intended for design, materials, construction, inspection, and testing
of vessels, piping, and related accessories such as pumps, valves, and fittings for use in
the biopharmaceutical industry. The rules provide for the adoption of other ASME and
related national standards, and when so referenced become part of the standard.
(a) At the 1989 WAM, an ad hoc committee was formed to assess the need to develop further
the scope and action plan. The committee met in 1990 and there was consensus concerning
the need to develop standards that would meet the requirements of operational bioprocessing,
including:
(1) the need for equipment designs that are both cleanable and sterilizable
(2) the need for special emphasis on the quality of weld surfaces once the required strength
is present
(3) the need for standardized definitions that can be used by material suppliers, designers/
fabricators, and users
(4) the need to integrate existing standards covering vessels, piping, appurtenances, and
other equipment necessary for the biopharmaceutical industry without infringing on the scopes
of those standards
(b) The BPE Main Committee was structured with six functioning subcommittees and an
executive committee comprising the main committee chair and the subcommittee chairs. The
initial subcommittees were
(1) General Requirements
(2) Design Relating to Sterility and Cleanability of Equipment
(3) Dimensions and Tolerances
(4) Material Joining
(5) Surface Finishes
(6) Seals
(c) Throughout the development of the Standard, close liaison was made with the European
CEN, ASTM, and the AAA Dairy Standards. The purpose was to develop an ASME standard
that would be distinctive, germane, and not in conflict with other industry standards. Wherever
possible, the Committee strived to reference existing standards that are applicable to biopharma-
ceutical equipment design and fabrication.
This Standard represents the work of the BPE Standards Committee, and this edition includes
the following Parts:
(1) General Requirements
(2) Systems Design
(3) Dimensions and Tolerances for Process Components
(4) Materials Joining
(5) Product Contact Surface Finishes
(6) Sealing Components
(7) Polymeric and Other Nonmetallic Materials
(8) Certification
(9) Metallic Materials of Construction
(10) Process Instrumentation

ix

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
The first edition of this Standard was approved as an American National Standard on
May 20, 1997. This edition was approved by ANSI on May 30, 2014.
Requests for interpretations or suggestions for revision should be sent to Secretary,
BPE Committee, The American Society of Mechanical Engineers, Two Park Avenue,
New York, NY 10016.

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
STATEMENT OF POLICY ON THE USE OF
CERTIFICATION MARKS AND CODE AUTHORIZATION
IN ADVERTISING

ASME has established procedures to authorize qualified organizations to perform various


activities in accordance with the requirements of the ASME Codes and Standards. It is the aim
of the Society to provide recognition of organizations so authorized. An organization holding
authorization to perform various activities in accordance with the requirements of the Codes and
Standards may state this capability in its advertising literature.
Organizations that are authorized to use the Certification Mark for marking items or construc-
tions that have been constructed and inspected in compliance with ASME Codes and Standards
are issued Certificates of Authorization. It is the aim of the Society to maintain the standing of
the Certification Mark for the benefit of the users, the enforcement jurisdictions, and the holders
of the Certification Mark who comply with all requirements.
Based on these objectives, the following policy has been established on the usage in advertising
of facsimiles of the symbols, Certificates of Authorization, and references to Codes or Standards
construction. The American Society of Mechanical Engineers does not approve, certify, rate,
or endorse any item, construction, or activity and there shall be no statements or implications
that might so indicate. An organization holding a Certification Mark and/or a Certificate of
Authorization may state in advertising literature that items, constructions, or activities are built
(produced or performed) or activities conducted in accordance with the requirements of the
applicable ASME Code or Standard. An ASME corporate logo shall not be used by any organiza-
tion other than ASME.
The Certification Mark shall be used only for stamping and nameplates as specifically provided
in the Code or Standard. However, facsimiles may be used for the purpose of fostering the use
of such construction. Such usage may be by an association or a society, or by a holder of a
Certification Mark who may also use the facsimile in advertising to show that clearly specified
items will carry the Certification Mark. General usage is permitted only when all of a manufactur-
ers items are constructed under the rules of the applicable Code or Standard.

STATEMENT OF POLICY ON THE USE OF ASME


MARKING TO IDENTIFY MANUFACTURED ITEMS

The ASME Codes and Standards provide rules for the construction of various items. These
include requirements for materials, design, fabrication, examination, inspection, and stamping.
Items constructed in accordance with all of the applicable rules of ASME are identified with the
official Certification Mark described in the governing Code or Standard.
Markings such as ASME and ASME Standard or any other marking including ASME
or the Certification Mark shall not be used on any item that is not constructed in accordance
with all of the applicable requirements of the Code or Standard.
Items shall not be described on ASME Data Report Forms nor on similar forms referring to
ASME which tend to imply that all requirements have been met when in fact they have not been.
Data Report Forms covering items not fully complying with ASME requirements should not refer
to ASME or they should clearly identify all exceptions to the ASME requirements.
ASMEs certification related to products means that the capability by the supplier to fulfill
requirements in the applicable standard has been reviewed and accepted by ASME. The supplier
is responsible for ensuring that products meet, and if applicable continue to meet, the requirements.

xi

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BIOPROCESSING EQUIPMENT COMMITTEE
(The following is the roster of the Committee at the time of approval of this Standard.)

STANDARDS COMMITTEE OFFICERS


J. Ankers, Chair
M. Pelletier, Vice Chair
P. D. Stumpf, Secretary

STANDARDS COMMITTEE PERSONNEL


J. Ankers, M + W Group K. D. Kimbrel, UltraClean Electropolish
M. L. Balmer, Sanofi Pasteur D. T. Klees, Magnetrol International
D. D. Baram, Contributing Member, Clifton Enterprises G. Kroehnert, Neumo
E. A. Benway, Contributing Member, Ironwood Specialist I. Lisboa, RathGibson
W. H. Cagney, Johnson & Johnson J. T. Mahar, 3M Purification
R. D. Campbell, Bechtel F. J. Manning, VNE
A. P. Cirillo, Cirillo Consulting Services D. M. Marks, DME Alliance
R. A. Cotter, Cotter Brothers D. J. Mathien, Behringer
J. Dvorscek, Abbott Laboratories M. McFeeters, Steridose
S. Murakami, Hitachi
M. Embury, ASEPCO
C. N. Pacheco, Amgen
E. B. Fisher, Fisher Engineering
M. Pelletier, CRB
M. M. Gonzalez, Contributing Member, BioPharm Engineering
L. J. Peterman, United Industries
Consultant
W. L. Roth, Procter & Gamble
Z. Gu, Shanghai Morimatsu R. Snow, Genzyme
R. Hanselka, CRB P. D. Stumpf, The American Society of Mechanical Engineers
B. K. Henon, Magnatech P. L. Sturgill, SWCC
M. A. Hohmann, Quality Coalescence C. A. Trumbull, Paul Mueller Co.
L. T. Hutton, Arkema J. D. Vogel, The BioProcess Institute
C. Johnson, Genentech/Roche R. J. Zinkowski, Consultant
C. Kettermann, RathGibson M. Zumbrum, Maztech

EXECUTIVE COMMITTEE

M. Pelletier, Chair, CRB K. D. Kimbrel, Ultraclean Electropolish


J. Ankers, Vice Chair, M + W Group D. T. Klees, Magnetrol International
W. H. Cagney, Johnson & Johnson D. M. Marks, DME Alliance
D. J Mathien, Behringer Corp.
R. D. Campbell, Bechtel
M. McFeeters, Steridose
A. P. Cirillo, Cirillo Consulting Services D. Smith, Consultant
M. Embury, ASEPCO P. L. Sturgill, SWCC
B. K. Henon, Magnatech R. J. Zinkowski, Consultant
C. E. Kettermann, RathGibson M. Zumbrum, Maztech

SUBCOMMITTEE ON GENERAL REQUIREMENTS AND EDITORIAL REVIEW

M. Embury, Chair, ASEPCO L. Harper, Consultant


T. J. Winter, Vice Chair, Winter Technologies B. K. Henon, Magnatech
T. Fridman, Secretary, Vanasyl M. A. Hohmann, Quality Coalescence
E. A. Benway, Contributing Member, Ironwood Specialist D. Kwilosz, Eli Lilly & Co.
J. L. Bradley, Eli Lilly & Co. J. W. Minor, Paul Mueller Co.
W. P. Burg, DECCO V. Norton, Stainless Integrity
W. H. Cagney, Johnson & Johnson W. Ortiz, Contributing Member, Eli Lilly & Co.
R. D. Campbell, Bechtel M. Pelletier, CRB
A. P. Cirillo, Contributing Member, Cirillo Consulting Services K. Seibert, ABEC
R. Fitts, Spraying Systems Co. P. L. Sturgill, SWCC

xii

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
SUBCOMMITTEE ON SYSTEMS DESIGN

D. M. Marks, Chair, DME Alliance S. M. Hartner, Baxter International


M. L. Balmer, Vice Chair, Sanofi Pasteur J. Hays, 3M Purification
A. Dyrness, Vice Chair, ADVENT Engineering Services T. L. Hobick, Holland Applied Technologies
B. Jensen, Vice Chair, Alfa Laval D. Hogensen, Amgen
R. A. Michalak, Secretary, Eli Lilly & Co. M. Inoue, Fujikin
J. Ankers, M + W Group C. Johnson, Genentech/Roche
D. D. Baram, Clifton Enterprises C. Kelleher, Johnson & Johnson
B. A. Billmyer, Central States Industrial Equipment L. Klitgaard, NNE Pharmaplan
J. L. Bradley, Eli Lilly & Co. P. M. Kubera, ABEC
T. M. Canty, Contributing Member, JM Canty Associates, Inc. J. D. Larson, DCI
J. Mahar, 3M Purification
C. Chapman, GEMU Valves
R. Manser, DCI
R. A. Cotter, Cotter Brothers
D. P. McCune, Allegheny Bradford
J. Crawley, Jacobs Engineering
M. McFeeters, Steridose
J. Daly, BSI Engineering
J. W. Minor, Paul Mueller Co.
J. Dvorscek, Abbott Laboratories
S. Muller, GE Healthcare
M. Embury, ASEPCO A. R. Obertanec, Clark-Reliance
J. Feldman, Yula Corp. W. Ortiz, Contributing Member, Eli Lilly & Co.
E. B. Fisher, Fisher Engineering C. N. Pacheco, Amgen
G. P. Foley, Sr., PBM G. Page, Jr., Page Solutions
R. F. Foley, M + W Group M. Pelletier, CRB
J. Fortin, Lonza A. Powell, Consultant
J. Franks, Electrol Specialties Co. S. Sharon, Genentech/Roche
R. Gerra, Shire Pharmaceuticals R. Snow, Genzyme
Z. Gu, Shanghai Morimatsu K. J. Westin, Roplan Sales
R. Hanselka, CRB R. J. Zinkowski, Consultant

SUBCOMMITTEE ON DIMENSIONS AND TOLERANCES


D. J. Mathien, Chair, Behringer G. Kroehnert, Neumo
F. J. Manning, Vice Chair, VNE I. Lisboa, RathGibson
B. A. Billmyer, Secretary, Central States Industrial Equipment M. Manfredi, ZDL Componentes de Processo
D. Brockman, Alfa Laval P. McClune, ITT Engineered Valves
C. Chapman, GEMU Valves H. P. G. Montgomery, Tank Components Industries
R. Cosentino, GILTEC R. Narayanan, Value Plastics
P. M. Dunbar, VNE L. J. Peterman, United Industries
R. J. Elbich, Exigo Manufacturing F. G. Villela, Stockval Tecno Comercial
R. B. Fitts, Spraying Systems Co. T. G. Wilson, Contributing Member, Consultant
R. F. Foley, M + W Group T. J. Winter, Winter Technologies

SUBCOMMITTEE ON MATERIALS JOINING


R. D. Campbell, Chair, Bechtel M. A. Hohmann, Quality Coalescence
J. Dvorscek, Vice Chair, Abbott Laboratories W. M. Huitt, W. M. Huitt Co.
C. W. Elkins, Vice Chair, Central States Industrial Equipment L. T. Hutton, Arkema
W. L. Roth, Secretary, Procter & Gamble C. E. Kettermann, RathGibson
E. A. Benway, Contributing Member, Ironwood Specialist K. J. Matheis, Sr., Complete Automation
K. Bhaila, ITT Engineered Valves N. S. McCauley, A & B Process Systems
N. K. Bickel, Genentech/Roche T. M. OConnor, Central States Industrial Equipment
J. L. Bradley, Eli Lilly & Co. W. Ortiz, Contributing Member, Eli Lilly & Co.
W. P. Burg, DECCO H. A. Reinhold, FST Technical Services
T. J. Cook, T & C Stainless M. S. Solamon, Feldmeier Equipment
R. A. Cotter, Cotter Brothers D. P. Sisto, Purity Systems
J. D. Fritz, TMR Stainless P. L. Sturgill, SWCC
E. L. Gayer, Holloway America G. R. Tabor, Eli Lilly & Co.
D. A. Gillespie, BMWC Constructors C. A. Trumbull, Past Chair, Paul Mueller Co.
R. Hanselka, CRB B. J. Uhlenkamp, Contributing Member, DCI
B. K. Henon, Magnatech C. Weeks, CRB

xiii

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
SUBCOMMITTEE ON SURFACE FINISH
K. D. Kimbrel, Chair, UltraClean Electropolish S. T. Harrison, Harrison Electropolishing
P. H. Banes, Vice Chair, Astro Pak B. K. Henon, Magnatech
J. Hamilton, Vice Chair, RathGibson G. Kroehnert, Neumo
R. E. Avery, Nickel Institute C. F. Kuo, King Lai Hygienic Material Co.
D. Brockmann, Alfa Laval F. J. Manning, VNE
D. K. Cohen, Contributing Member, Michigan Metrology R. McGonigle, Active Chemical
M. Mondello, MECO
T. J. Cook, T & C Stainless
L. J. Peterman, United Industries
M. D. Cooper, United Industries
P. A. Petrillo, Millennium Facilities Resources
J. R. Daniels, ITT Engineered Valves R. K. Raney, UltraClean Electropolish
C. W. Elkins, Central States Industrial Equipment J. Rau, Dockweiler AG
E. L. Gayer, Holloway America P. D. Sedivy, Past Chair, RathGibson
J. Giffen, PBM M. S. Solamon, Feldmeier Equipment
M. M. Gonzalez, Contributing Member, BioPharm Engineering C. Taylor, Crane Saunders
Consultant C. A. Trumbull, Paul Mueller Co.

SUBCOMMITTEE ON SEALING COMPONENTS


M. McFeeters, Chair, Steridose J. Marshall, Perrigo
J. D. Vogel, Vice Chair, The BioProcess Institute R. A. Michalak, Eli Lilly & Co.
K. J. Westin, Secretary, Roplan Sales A. R. Obertanec, Clark-Reliance
D. D. Baram, Clifton Enterprises C. N. Pacheco, Amgen
J. Blumenthal, Perceptual Focus G. Page, Jr., Page Solutions
J. Daniels, ITT Engineered Valves A. K. Parker, Jr., W. L. Gore & Associates
S. J. DeFusco, Integra Companies S. Pitolaj, Garlock Sealing Technologies
D. Donnelly, James Walker Sealing Products & Services J. Pouliot, Amgen
A. Powell, Consultant
R. Dubiel, Parker Hannifin
R. Rieger, John Crane
P. Esbensen, Alfa Laval Kolding A/S
W. Sams, Steriflow
G. P. Foley, PBM
R. W. Schnell, DuPont Performance Polymers
J. Giffen, PBM R. Schroder, Newman Sanitary Gasket Co.
B. Gregg, Topline Process Equipment R. A. Smith, Flowserve
L. Harper, Consultant J. Vitti, Crane ChemPharma Flow Solutions
T. Harvey, Gemu Valves D. Wise, Genentech/Roche
D. Helmke, Flow Products N. Wu, Fristam Pumps
M. Inoue, Fujikin R. J. Zinkowski, Consultant
C. Johnson, Genentech/Roche M. A. Zumbrum, Maztech

SUBCOMMITTEE ON POLYMERS AND OTHER NONMETALLIC MATERIALS


M. A. Zumbrum, Chair, Maztech M. W. Johnson, Entegris
T. Fridman, Vice Chair, Vanasyl C. Kollar, Dow Corning Co.
L. T. Hutton, Vice Chair, Arkema T. Larkin, Amgen
P. G. Galvin, Secretary, George Fischer J. Mahar, 3M Purification
M. Allard, NewAge Industries, Inc./Advantapure R. Narayanan, Value Plastics
T. Andrews, Colder Products E. Pitchford, Parker Hannifin
G. E. Carpenter, Saint-Gobain Performance Plastics R. W. Schnell, DuPont Performance Elastomers
A. Cobb, W. L. Gore & Associates R. P. Schroder, Newman Gasket
K. R. Davis, Value Plastics D. A. Seiler, Arkema
S. J. DeFusco, Integra Companies R. Snow, Genzyme
D. Donnelly, James Walker & Co. J. Stover, NewAge Industries, Inc./AdvantaPure
G. Evans, Aflex Hose, USA J. D. Vogel, The BioProcess Institute

SUBCOMMITTEE ON METALLIC MATERIALS


P. L. Sturgill, Chair, SWCC S. T. Harrison, Harrison Electropolishing
J. Rau, Vice Chair, Dockweiler AG W. M. Huitt, W. M. Huitt Co.
N. A. Schmidt, Secretary, Complete Automation C. E. Kettermann, RathGibson
P. Anderson, Northland Stainless K. J. Matheis, Sr., Complete Automation
R. E. Avery, Nickel Institute D. P. McCune, Allegheny Bradford
R. D. Campbell, Bechtel T. M. OConnor, Central States Industrial
J. W. Franks, Electrol Specialties Co. D. L. Roll, Astro Pak
J. D. Fritz, TMR Stainless W. L. Roth, Procter & Gamble
D. A. Gillespie, BMWC Constructors

xiv

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
SUBCOMMITTEE ON CERTIFICATION REQUIREMENTS
C. E. Kettermann, Chair, RathGibson M. M. Gonzalez, BioPharm Engineering Consultant
T. L. Hobick, Vice Chair, Holland Applied Technologies D. R. Helmke, Flow Products
B. A. Billmyer, Central States Industrial Equipment M. A. Hohmann, Quality Coalescence
D. Brockmann, Alfa Laval W. M. Huitt, W. M. Huitt Co.
R. D. Campbell, Bechtel Construction Operations L. T. Hutton, Arkema
P. M. Dunbar, VNE K. D. Kimbrel, UltraClean Electropolish
J. Dvorscek, Abbott Laboratories K. J. Matheis, Sr., Complete Automation
R. J. Elbich, Exigo Manufacturing A. R. Obertanec, Clark-Reliance
E. L. Gayer, Holloway America W. L. Roth, Procter & Gamble
D. A. Gillespie, BMWC Constructors T. G. Wilson, Top Line Process Equipment Co.

SUBCOMMITTEE ON PROCESS INSTRUMENTATION


D. T. Klees, Chair, Magnetrol International R. Govaert, Mettler-Toledo Ingold/Thornton
T. M. Canty, Vice Chair, J. M. Canty D. Kresge, CRB
V. Gorbis, Vice Chair, Genentech/Roche A. Lamore, Burkert Fluid Control Systems
D. Kwilosz, Secretary, Eli Lilly & Co. J. Nerstad, Magnetrol International
J. Ankers, Contributing Member, M + W Group P. A. Petrillo, Millennium Facilities Resources
G. Anton, Qualtech G. Placide, Crosspoint Engineering
J. Blumenthal, Perceptual Focus R. Shankar, Endress + Hauser
R. Bond, Anderson Instrument Co. S. Sharon, Genentech/Roche
C. Bragg, Burns Engineering G. Tischler, Vega Americas
J. Defeo, Hoffer Flow Controls P. Wagner, Anderson Instrument Co.
J. M. Featherston, Weed Instrument Co. G. Woods, CrossPoint Engineering
J. Gleeson, Hamilton Co. S. Zuehlke, Endress + Hauser GmbH Co. KG

xv

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014
SUMMARY OF CHANGES

Following approval by the ASME BPE Committee and ASME, and after public review,
ASME BPE-2014 was approved by the American National Standards Institute on May 30, 2014.

ASME BPE-2014 includes editorial changes, revisions, and corrections introduced in


ASME BPE-2012, as well as the following changes identified by a margin note, (14).
Page Location Change
1 GR-1 First paragraph revised
GR-2 First paragraph and subpara. (f) revised
2 GR-4.1 Subparagraph (a) revised
3, 4 Table GR-4.2-1 Welder and/or Welding Operator title
and entry revised
5 GR-4.2.3 Subparagraph (d) revised
GR-4.3.1 Revised
616 GR-5 Revised in its entirety
GR-6 Revised
GR-7 Revised
GR-8 (1) Definitions of biopharmaceuticals,
bioprocessing, buffing, heat-affected zone,
hygienic clamp joint, hygienic joint, and
product contact surface revised
(2) Definitions of bioprocess, expiration
date, luster, material manufacturer,
material test report, mechanical polishing,
process contact surface, shelf life,
significant change (polymeric), and
variance in luster added
(3) Definition of star burst deleted
17 SD-1 Revised
SD-2 Revised
SD-2.1 Revised
SD-2.3.1.1 Second paragraph revised
SD-2.4 First and third paragraphs revised
18 SD-2.4.2 Revised in its entirety
19, 20, 26 SD-2.4.3.2 Subparagraph (a) revised
SD-2.4.3.3 Revised
SD-2.4.4.3 Revised
SD-3.1.1 (1) Subparagraphs (c), (e), and (h) revised
(2) Subparagraph (i) added
SD-3.1.2.3 First word in subpara. (i) revised

xvi

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
Page Location Change
21 Fig. SD-3.1.1-1 Revised
25 Fig. SD-3.1.2.2-1 (1) Notes added (2012 Errata)
(2) Revised
27 SD-3.2.1 Subparagraphs (a) and (b) revised
SD-3.2.2 Subparagraphs (a) and (b) revised
SD-3.3.2.1 Second word in subpara. (b) revised
28 Fig. SD-3.2.1-1 Revised
SD-3.3.2.4 Second word in subpara. (e) revised
29 Fig. SD-3.3.2.2-2 Revised
30 Fig. SD-3.3.2.2-4 Revised
31 Fig. SD-3.3.2.4-1 Revised
SD-3.4.1 Subparagraph (d) revised
32 Fig. SD-3.4.2-1 Revised
33 Fig. SD-3.4.2-2 Revised
Fig. SD-3.4.2-3 Revised
34 Fig. SD-3.4.2-4 Revised
35 Fig. SD-3.4.2-5 Revised
37 Fig. SD-3.4.2-7 Revised
SD-3.4.5 First word in subpara. (b) revised
38 Fig. SD-3.4.3-1 Revised
39 SD-3.5.1 Subparagraphs (a), (b), (f)(3), and (h)
revised
40 Fig. SD-3.5.1-1 Revised
41 Fig. SD-3.5.2-1 Revised
42 Fig. SD-3.5.2-2 Revised
43, 45, 47 Fig. SD-3.5.2-3 Revised
SD-3.6.1 Subparagraphs (b), (c)(1), (g)(1), (h)(2),
and (h)(3) revised
Fig. SD-3.5.5-2 Revised
SD-3.6.2 Second word in subpara. (a) revised
SD-3.7.1 Subparagraph (a) revised
49 Fig. SD-3.7.2-1 Revised
50 Fig. SD-3.7.4-1 Revised
51 SD-3.8 Added
53, 55 SD-3.9.2 First word in subpara. (j) revised
54 Fig. SD-3.9.1-2 Revised
56 Fig. SD-3.9.2.1-1 Revised

xvii

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
Page Location Change
58 Fig. SD-3.12-1 Revised
59 SD-3.13 Revised in its entirety
SD-3.15 Revised in its entirety
61 Fig. SD-4.1.2.1-1 Revised
62 SD-4.2.3 Subparagraph (b) revised
63 Fig. SD-4.2.2-1 Revised
64 Fig. SD-4.2.2-2 Revised
68 Fig. SD-5.1.1.2.3-1 Revised
69 Fig. SD-5.1.1.2.3-2 Revised
70 Fig. SD-5.1.1.2.3-3 Revised
71 Fig. SD-5.1.1.2.3-4 Revised
74 Fig. SD-5.1.1.3.1-3 Revised
76 SD-5.1.3.2 Title revised
SD-5.2.1.1 Subhead moved and retitled
SD-5.2.1.1.2 Subparagraph (a) revised
SD-5.2.1.2 Redesignated
SD-5.2.1.3 Redesignated
SD-5.2.1.4 Redesignated
77 SD-5.2.3.2.1 Revised
78 SD-5.3.2.3.1 Subparagraph (c) revised
82 Fig. SD-5.3.3.5.1-1 Revised
8389 SD-5.4 Added
SD-6 SD-6, SD-6.1, SD-6.3, and SD-6.4 revised
in their entireties
90 DT-4 Revised
DT-4.1.4 Revised
DT-4.3 Revised
91, 92 DT-7 Third paragraph revised
DT-9.1 Revised
DT-10.1 (1) Subparagraph (e) revised
(2) Subparagraphs (f)(1) and (f)(2) added
DT-11.1 (1) First paragraph and subparas. (a) and
(e) revised
(2) Subparagraphs (d)(1) and (d)(2)
added
DT-11.2 (1) First paragraph and subpara. (f)
revised
(2) Subparagraphs (e)(1) and (e)(2) added
93 DT-11.3 Added

xviii

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
Page Location Change
96 Table DT-3-1 General Note (c) revised
108 Table DT-4.1.3-1 (1) Designation revised
(2) Table DT-4.1.3-1(a) deleted
109 Table DT-4.1.3-2 (1) Designation revised
(2) Table DT-4.1.3-2(a) deleted
110 Table DT-4.1.3-3 (1) Designation revised
(2) Table DT-4.1.3-3(a) deleted
112 Table DT-4.1.5-2 Revised in its entirety
114, 115 Table DT-7-1 (1) In Groove Detail for Type A, second
arrowhead for R4 callout added (2012
Errata)
(2) Under Type B, Nominal Size, in., first
entry corrected to read 1 (2012
Errata)
(3) Also under Type B, for Nominal Size
6, I.D. Bore, B, in., value for
Dimension corrected to read 5.782
(2012 Errata)
117 Table DT-9.3-1 With callout at top center of right
illustration, Clearance per DT-9.4(e),
arrow placement corrected (2012
Errata)
118139 Part MJ Revised in its entirety
140144 Part SF Revised in its entirety
149, 155 SG-2.3.1.2 Subparagraphs (a) and (b) revised
SG-2.3.1.9 Revised in its entirety
154 Fig. SG-2.3.1.9-1 Revised
155, 156 SG-2.3.2.3 Subparagraph (b)(1) revised
157159 SG-2.3.2.4 New subparagraphs (c) and (j) added,
and subsequent subparagraphs
redesignated
Fig. SG-2.3.2.4-3 Added, and subsequent SG-2.3.2.4 figures
redesignated
160 Fig. SG-2.3.2.4-13 Added, and subsequent SG-2.3.2.4 figures
redesignated
Fig. SG-2.3.2.4-14 Added, and subsequent SG-2.3.2.4 figures
redesignated
161 SG-3.2.1 Subparagraph (a) revised
SG-3.2.2 First paragraph revised
162165 SG-3.3.2.1 Subparagraph (b) revised
SG-3.3.2.2 Revised in its entirety
SG-3.3.2.3 Subparagraphs (a)(3), (a)(4), (c)(1)(-a)(-1),
and (e) revised
168 SG-4.3.1.1 Added

xix

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
Page Location Change
170 PM-2.1.2 Third paragraph revised
171 Table PM-2.1.1-1 Third entry in third column revised
PM-2.2 Second paragraph revised
172 Table PM-2.1.3-1 Fourth entry in third column added
PM-3.1 Second paragraph revised
173 Table PM-2.2.1-1 (1) Title and fourth entries in eighth and
ninth columns revised
(2) Eleventh column added
PM-3.2.1 Revised
PM-3.2.3.1 First and fourth paragraphs revised
PM-3.2.3.2 Fourth paragraph revised
174, 175 PM-3.2.4.4 Added
PM-3.7 Added
PM-3.8 Added, and subsequent paragraph
redesignated
PM-4.1.2 Revised
PM-4.1.4 First paragraph revised
176 PM-4.1.5.1 Revised in its entirety
PM-4.1.6 Added
PM-4.2.3 Definition of T under first equation
revised
178 PM-4.2.5 Paragraphs PM-4.2.6 through PM-4.2.9
deleted
PM-4.3.2.5 Subparagraph (c) revised
179181 PM-4.4 Added
PM-4.6 Added
PM-4.7 Added
182186 Part CR Revised in its entirety
187 MM-2.1 Revised
MM-3.3 Second paragraph added
MM-3.6 Revised
188 Table MM-2.1-1 Revised in its entirety
190, 191 Table MM-2.1-3 (1) Fifth row under Austenitic Stainless
Steels deleted
(2) First row under Superaustenitic
Stainless Steels added
Table MM-2.1-4 Added
MM-4.2 Revised

xx

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
Page Location Change
192, 193 MM-4.7 Added
MM-5.1.1 Revised
MM-5.1.2 Revised
MM-5.1.4 Revised
MM-5.1.5 Revised
MM-5.1.6 Added
194, 195 Table MM-5.1.2-1 Revised in its entirety
196 Table MM-5.1.2-2 (1) First six rows under Superaustenitic
Stainless Steels revised
(2) General Note (b) deleted
(3) Note (1) added
Table MM-5.1.5-1 Added
197 Table MM-5.2.5-1 Added
MM-5.2.5 Added
MM-5.3 Revised
MM-5.4 Revised
MM-6.2 Revised
MM-6.3 Title revised
MM-6.4 Revised
198 MM-6.5 Revised
MM-8 (1) Title and subparas. (a), (b), and (d)
revised
(2) Subparagraph (c) deleted, and
remaining subparagraphs
redesignated
202 PI-4.1.2 Second paragraph revised
204211 PI-5 Added
PI-7 Added
214 PI-8.1.5 Subparagraph (c) revised
219 PI-9.1.3.2 First word revised
225 Mandatory Appendix II Added
227230 Nonmandatory Appendix B Revised in its entirety
232 D-1 Revised in its entirety
234 Table D-2-1 Electropolishing entry revised
235 Table D-2-2 Gaseous phase composition entry revised
239, 240 Table D-4.1-1 Revised in its entirety
241250 Nonmandatory Appendix E Revised in its entirety
261267 J-1 Revised in its entirety
272 Table K-3-1 Fourth entries in first and second
columns and eighth entry in second
column revised

xxi

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
Page Location Change
277 Nonmandatory N-1 head and section N-2 added
Appendix N
278 Nonmandatory (1) Title revised
Appendix O (2) O-1 head and sections O-2 and O-3
added
279, 280 Nonmandatory Appendix P Revised in its entirety
285 Nonmandatory Appendix S Added
286, 287 Nonmandatory Appendix T Added
289301 Index Updated

xxii

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

BIOPROCESSING EQUIPMENT

Part GR
General Requirements

(14) GR-1 INTRODUCTION GR-2 SCOPE OF THE ASME BPE STANDARD (14)

The ASME Bioprocessing Equipment Standard was The ASME BPE Standard provides requirements for
developed to aid in the design and construction of new systems and components that are subject to cleaning
fluid processing equipment used in the manufacture of and sanitization and/or sterilization including systems
biopharmaceuticals, where a defined level of purity and that are cleaned in place (CIPd) and/or steamed in
bioburden control is required. place (SIPd) and/or other suitable processes used in
The Standard typically applies to the manufacturing of biopharmaceuticals. This Standard
(a) components that are in contact with the product, also provides requirements for single use systems and
raw materials, or product intermediates during manu- components used in the above listed systems and com-
facturing, development, or scale-up ponents. This Standard may be used, in whole or in part,
(b) systems that are a critical part of product manufac- for other systems and components where bioburden risk
ture [e.g., water-for-injection (WFI), clean steam, filtra- is a concern.
tion, and intermediate product storage] This Standard applies to
The General Requirements Part states the scope of (a) new system (and component) design and
the ASME BPE Standard and provides references and fabrication
definitions that apply throughout the document. (b) definition of system boundaries
When operating under pressure conditions, systems (c) specific metallic, polymeric, and elastomeric (e.g.,
shall be constructed in accordance with the ASME Boiler seals and gaskets) materials of construction
and Pressure Vessel Code (BPVC), Section VIII, and/or (d) component dimensions and tolerances
ASME B31.3 Process Piping Code or applicable local,
(e) surface finishes
national, or international codes or standards. The
(f) materials joining
owner/user may stipulate additional or alternative
(g) examinations, inspections, and testing
specifications and requirements.
This Standard shall govern the design and construc- (h) certification
tion of piping systems for hygienic service. For process This Standard is intended to apply to new fabrication
piping systems designed and constructed in accordance and construction. It is not intended to apply to existing,
with ASME B31.3, it is the owners responsibility to in-service equipment. If the provisions of this Standard
select a fluid service category for each fluid service. are optionally applied by an owner/user to existing, in-
Should any fluid service meet the definition of high service equipment, other considerations may be neces-
purity fluid service (ASME B31.3, Chapter X) it is recom- sary. For installations between new construction and an
mended that such fluid service be selected and the existing, in-service system, the boundaries and require-
requirements of this Standard and ASME B31.3, ments must be agreed to among the owner/user, engi-
Chapter X be met. neer, installation contractor, and inspection contractor.
When an application is covered by laws or regulations For a system or component to be BPE-compliant,
issued by an enforcement authority (e.g., municipal, pro- adherence to all applicable parts of this Standard is
vincial, state, or federal), the final construction require- required.
ments shall comply with these laws.
Items or requirements that are not specifically GR-3 MANUFACTURERS QUALITY ASSURANCE
addressed in this Standard are not prohibited. Engi- PROGRAM
neering judgments must be consistent with the funda-
mental principles of this Standard. Such judgments shall The manufacturer shall implement a quality assurance
not be used to override mandatory regulations or spe- program describing the systems, methods, and proce-
cific prohibitions of this Standard. dures used to control materials, drawings, specifications,

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

fabrication, assembly techniques, and examination/ according to the capabilities requirements under the
inspection used in the manufacturing of bioprocessing supervision of, at a minimum, a QID-2.
equipment. (c) Quality Inspector Delegate 2 (QID-2). This individ-
ual shall be qualified to set up and calibrate equipment
and to interpret and evaluate results with respect to
GR-4 INSPECTION
applicable codes, standards, and specifications. The
The inspection requirements are specified in each Part QID-2 shall be thoroughly familiar with the scope and
of this Standard. If an inspection or examination plan limitations of the inspection they are performing and
is required, it shall be developed and agreed to by the shall exercise assigned responsibility for on-the-job
owner/user, contractor, inspection contractor, and/or training and guidance of trainees and QID-1 personnel.
engineer ensuring that the systems and components A QID-2 may perform tests and inspections according
meet this Standard. to the capabilities requirements.
(d) Quality Inspector Delegate 3 (QID-3). This individ-
(14) GR-4.1 Inspector/Examiner ual shall be capable of establishing techniques and pro-
Inspector and examiner in this Standard shall be cedures; interpreting codes, standards, specifications,
defined for the following: and procedures; and designating the particular inspec-
(a) Pressure Vessels. Authorized Inspector, as defined tion methods, techniques, and procedures to be used.
in ASME BPVC, Section VIII. The QID-3 shall have sufficient practical background in
(b) Piping, Tubing, and Non-Code Vessels. Owner s applicable materials, fabrication, and product technol-
inspector, as defined in ASME B31.3, paras. 340.4(a) and ogy to establish techniques and to assist in establishing
(b). Inspectors Delegate, as defined in GR-8, meets the acceptance criteria when none are otherwise available.
additional requirements listed in GR-4.2. The QID-3 shall be capable of training personnel. A
(c) Piping and Tubing. Examiner, defined as a person QID 3 may perform tests and inspections according to
who performs quality control examinations for a manu- the capabilities requirements.
facturer as an employee of the manufacturer as defined
GR-4.2.2 Qualification Requirements. The qualifica-
in ASME B31.3, para. 341.1.
tion requirements listed herein shall be met prior to
When local regulations require that pressure equip-
consideration for examination/certification.
ment be designed and constructed in accordance with
standards other than ASME codes/standards, the (a) Trainee
inspector in this Standard is defined as one who is (1) be a high school graduate or hold a state or
acceptable to the relevant regulatory authority. military approved high school equivalency diploma
(2) receive a minimum of 8 hr of relevant docu-
GR-4.2 Inspectors Delegate mented training (total 8 hr), including as a minimum
Inspectors Delegate qualifications shall be in accor- the requirements shown in Table GR-4.2-1
dance with the requirements listed herein. The employer (b) QID-1. To be considered as a QID-1, personnel
of the Inspectors Delegate shall have documented train- shall meet the following:
ing and qualification programs to ensure the qualifica- (1) be a trainee for a minimum of 6 mo of docu-
tions and capabilities of personnel are met. mented relevant industry experience. Alternate methods
The capabilities requirements are listed in for meeting the work experience requirement are at least
Table GR-4.2-1. It is required that a capability listed one of the following:
for a lower level of qualification is also required for (a) prior or current certification as a QID-1
subsequent higher levels of qualification. (b) completion with a passing grade of at least
2 yr of engineering or science study in a university,
GR-4.2.1 Levels of Qualification. There are four lev-
college, or technical school
els of qualification for Inspectors Delegate. Examination
(c) possess an AWS CWI certificate1 or ACCP
personnel qualifications are not covered in this section
Level II VT certificate2, or international equivalent
but shall be in accordance with ASME B31.3, para. 342.
(a) Trainee. An individual who is not yet certified to (d) 2 yr of documented relevant experience in
any level shall be considered a trainee. Trainees shall inspection, examination, or testing activities
work under the direction of a certified Quality Inspector (2) receive a minimum of 16 additional hours of
Delegate and shall not independently conduct any tests relevant documented training (minimum total p 24 hr),
or write a report of test results.
(b) Quality Inspector Delegate 1 (QID-1). This individ- 1
ual shall be qualified to properly perform specific cali- Certifications from the American Welding Society (AWS). CAWI
is a Certified Associate Welding Inspector, and CWI is a Certified
brations, specific inspections, and specific evaluations Welding Inspector.
for acceptance or rejection according to written instruc- 2
Certifications from the American Society of Nondestructive
tions. A QID-1 may perform tests and inspections Testing (ASNT). ACCP is the ASNT Central Certification Program.

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table GR-4.2-1 Inspectors Delegate Capabilities (14)


Capability Trainee QID-1 QID-2 QID-3

Materials
(a) Identify materials
(1) Fitting type X ... ... ...
(2) Tube/pipe X ... ... ...
(3) Filler materials ... X ... ...
(4) Elastomers ... X ... ...
(5) Process components ... X ... ...
(b) Verify material marking to standard X ... ... ...
(c) Measure material dimensions X ... ... ...
(d) Measure material surface finish X ... ... ...
(e) Verify material documentation
(1) Material test reports (MTR) ... X ... ...
(2) Certificates of compliance ... X ... ...
(3) Instrument calibration records ... X ... ...
(4) Elastomers ... X ... ...
(f) Evaluate to acceptance criteria ... X ... ...
(g) Verify material compliance to specification ... X ... ...
(h) Verify material storage/handling compliance ... ... X ...

Equipment Use
(a) Mirrors/magnifiers X ... ... ...
(b) Measuring devices ... ... ... ...
(1) Steel rule X ... ... ...
(2) Calipers (dial, digital) X ... ... ...
(3) Fillet gauge ... X ... ...
(4) Radius gauge ... X ... ...
(5) Temperature sensitive crayon (tempilstick) ... X ... ...
(6) Slope level ... X ... ...
(7) Undercut gage ... X ... ...
(c) Borescope/fiberscope ... X ... ...
(d) Profilometer X ... ... ...
(e) Positive material identification (PMI) ... ... X ...
(f) Calibration records (inspection equipment) ... X ... ...

Knowledge and Skills


Understand inspection fundamentals
(a) Effective oral and written communication ... X ... ...
(b) Quality procedures
(1) Prepare documentation control requirements ... ... ... X
(2) Develop inspection procedures ... ... ... X
(c) Review of specifications ... ... X ...
(d) Codes and Standards (training)
(1) ASME BPE GR/DT/SF MJ/SD 3.12 X ...
(2) ASME B31.3 ... ... Chapter VI X
(3) ASME BPVC Section IX ... ... X ...
(e) Interpret welding symbols and drawings
(1) Detail drawings (mechanical) ... ... X ...
(2) P&ID ... ... X ...
(3) Single line isometric drawings (weld maps) ... X ... ...
(4) Isometric drawings (slope maps) ... X ... ...
(5) General/fabrication arrangement drawings (details) ... ... X ...
(6) Interpret welding symbols ... ... X ...
(f) Prepare documents/reports in accordance with GR-5.3
(1) Material examination log ... X ... ...
(2) Nonconformance reports ... X ... ...
(3) Visual weld inspection ... X ... ...
(4) Slope verification (isometric) ... X ... ...
(5) Pressure test ... ... X ...

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table GR-4.2-1 Inspectors Delegate Capabilities (Contd)


Capability Trainee QID-1 QID-2 QID-3

Knowledge and Skills (Contd)


(g) Turnover package
(1) Assemble ... ... X ...
(2) Review ... ... ... X
(h) Basic understanding of NDT/NDE
(1) PT ... ... X ...
(2) UT ... ... X ...
(3) RT ... ... X ...
(4) Eddy current ... ... X ...
(5) Pressure/leak testing ... ... X ...

Inspection
(a) Perform visual inspection (other than weld inspection) ... X ... ...
(b) Perform weld inspection ... X ... ...
(c) Evaluate weld inspection results ... ... X ...
(d) Perform slope verification ... X ... ...
(e) Witness pressure tests ... ... X ...
(f) Verify inspection compliance ... ... X ...
(g) Review inspection reports ... ... X ...
(h) Verify nonconformance disposition ... ... X ...
(i) Perform installation verification
(1) Installation per P&ID ... ... X ...
(2) Check for cold spring ... ... X ...
(3) Hanger verification ... X ... ...
(4) Component installation per manufacturers recommendations ... ... X ...

Vessel Inspection (additional to above)


(a) Verify surface finish ... ... X ...
(b) Verify drainability ... ... X ...
(c) Cleanability (CIP/riboflavin/sprayball testing) ... ... ... X
(d) Verify dimensions and orientation ... ... ... X
(e) Compliance with ASME Code (U-1) ... ... ... X
(f) Documentation review ... ... X ...

Welding Procedure Qualification


Verify welding procedures (WPS/PQR) compliance ... ... ... X

Welder and/or Welding Operator Performance Qualification


Verify welder and/or welding operator performance qualification ... ... X ...
compliance

Project Planning
(a) Review contract requirements ... ... ... X
(b) Prepare weld inspection criteria ... ... ... X
(c) Review specifications ... ... ... X
(d) Prepare purchase specifications ... ... ... X
(e) Develop inspection plan ... ... ... X
Training
(a) Provide on-the-job training for Quality Inspectors ... ... X ...
(b) Maintain records of training ... ... X ...
Audit
(a) Perform vendor audits ... ... ... X
(b) Perform fabricator audits ... ... ... X
(c) Prepare audit and surveillance plan ... ... ... X

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

including as a minimum the requirements shown in minimum of a Jaeger Number 2 or equivalent type and
Table GR-4.2-1 size letter at a distance designated on the chart but no
(3) pass a written test and practical performance less than 12 in. (305 mm). This test shall be administered
examination, including as a minimum the requirements initially and at least annually thereafter.
shown in Table GR-4.2-1 for this level (2) Color Contrast. The individual shall demonstrate
(c) QID-2. To be considered as a QID-2, personnel the capability of distinguishing and differentiating con-
shall meet the following: trast among colors. This test shall be administered ini-
(1) be a QID-1 for a minimum of 6 mo of docu- tially and, thereafter, at intervals not exceeding 3 yr.
mented relevant industry experience. Alternate methods These examinations shall be administered by an oph-
for meeting the work experience requirement are at least thalmologist, optometrist, medical doctor, registered
one of the following: nurse or nurse practitioner, certified physician assistant,
(a) prior or current certification as a QID-2 or by other ophthalmic medical personnel and shall
(b) completion with a passing grade of at least include the state or province (or applicable jurisdic-
4 yr of engineering or science study in a university, tional) license number.
college, or technical school (e) certification documentation
(c) possess an AWS CWI certificate1 or ACCP The owner/user is responsible for verifying the
Level II VT certificate2, or international equivalent requirements of this section are met.
(d) 2 yr of documented relevant experience in GR-4.2.4 Recertification. A QID-1, QID-2, or QID-3
inspection, examination, or testing activities of high whose employment has been terminated may be recerti-
purity/hygienic systems fied to their former level of qualification by a new or
(2) receive a minimum of 16 additional hours of former employer based on examination, provided all of
relevant documented training (minimum total p 40 hr), the following requirements are met:
including as a minimum the requirements shown in (a) The employee has proof of prior certification.
Table GR-4.2-1 (b) The employee was working in the capacity to
(3) pass a written test and practical performance which certified within 6 months of termination.
examination, including as a minimum the requirements (c) The employee is being recertified within 6 months
shown in Table GR-4.2-1 for this level of termination.
(d) QID-3. To be considered as a QID-3, personnel If the employee does not meet the listed requirements,
shall meet the following: additional training as deemed appropriate by the own-
(1) be a QID-2 for a minimum of 24 mo of docu- ers Inspector shall be required.
mented relevant industry experience. Alternate methods
for meeting the work experience requirement are at least GR-4.3 Responsibilities
one of the following: The responsibilities of inspection personnel are
(a) prior or current certification as a QID-3 defined in GR-4.3.1 and GR-4.3.2.
(b) 3 yr of documented relevant experience in
GR-4.3.1 Pressure Vessels. The responsibilities of (14)
inspection, examination, or testing activities of high
the owners Inspector shall be the same as the inspector
purity/hygienic systems
in ASME BPVC, Section VIII.
(2) receive a minimum of 40 additional hours of
relevant documented training, including as a minimum GR-4.3.2 Piping, Tubing, and Non-Code Vessels.
the requirements shown in Table GR-4.2-1 (minimum The responsibilities of the owner/users inspector shall
total p 80 hr) be in accordance with ASME B31.3, para. 340.2.
(3) pass a written test and practical performance
examination, including as a minimum the requirements GR-4.4 Access for Inspectors
shown in Table GR-4.2-1 for this level Manufacturers of bioprocessing equipment and com-
ponents shall allow free access of owner/user and
(14) GR-4.2.3 Certification. The employer is responsible authorized inspection personnel at all times while work
for training, testing, and certification of employees. The on the equipment or components is being performed.
employer shall establish a written practice in accordance The notification of an impending inspection should be
with the guidelines of ASNT SNT-TC-1A including mutually agreed to by the manufacturer and the inspec-
(a) the requirements listed in Table GR-4.2-1 tor. Access may be limited to the area of the manufactur-
(b) training programs ers facility where assembly, fabrication, welding, and
(c) certification testing requirements testing of the specific equipment or components is being
(d) eye examinations as follows: performed. Inspectors shall have the right to audit any
(1) Near Vision Acuity. The individual shall have examination, to inspect components using any examina-
natural or corrected near distance acuity in at least one tion method specified in the Design Specification
eye such that the individual is capable of reading a (including Purchase Order), and review all certifications

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

and records necessary to satisfy the requirements of (c) Weld Documentation (not required for standard fit-
GR-5. The manufacturer shall provide the inspector with tings, valves, and components unless specifically
work progress updates. required by the owner/user)
(1) weld maps
(2) weld logs
(14) GR-5 DOCUMENTATION
(3) weld examination and inspection logs
GR-5.1 General (4) coupon logs
Documentation requirements shall be agreed to at the (d) Testing and Examination Documentation (as
beginning of a design project and shall be made available applicable)
upon request or submitted at the agreed-upon time to (1) passivation reports
support the requirements of this Standard, as agreed to (2) spray device coverage testing
by the owner/user and manufacturer/contractor. (3) pressure testing
(4) final slope check documentation
GR-5.2 Document Requirements (5) calibration verification documentation
Material Test Reports (MTRs) shall be verified to be (6) purge gas certifications
in compliance with the applicable specification for all (7) signature logs
metallic process components that will come in contact (8) number of welds both manual and automatic
with the product and ancillary equipment. Certificates (9) number of welds inspected expressed as a
of Compliance (C of C) for all polymeric and other non- percentage (%)
metallic process components that come in contact with (10) heat numbers of components that must be
the product and ancillary equipment shall be verified. identified, documented, and fully traceable to the
In addition, the following documentation shall be pro- installed system
vided to the owner/user or their designee. (11) surface finish C of Cs
(12) NDE (nondestructive examination) reports
GR-5.2.1 General List of Documents (e) System/Equipment
GR-5.2.1.1 Metallic Materials (1) standard operating and maintenance proce-
dures and manuals
GR-5.2.1.1.1 Turn Over Package Documentation. (2) installation procedures
Documentation required for cGMP-validated distribu- (3) piping and instrumentation diagrams
tion systems, including the vessels, tubing systems on (4) detail mechanical drawings and layouts
modules, super skids, skids, the shop or field fabrication (5) technical specification sheets of components
of tubing, etc., includes the following: and instrumentation
(a) Materials Documentation (6) original equipment manufacturers data
(1) Material Test Reports (MTRs) (7) manufacturers data and test reports
(2) Certificates of Compliance (C of Cs) (8) any documentation that is specifically needed
(3) Material Examination Logs for the owner/users qualification of a system
(4) Identification of the filler metal or consumable
insert used for welding superaustenitic or duplex stain- GR-5.2.1.1.2 Technical support information to
less steel process components (see MM-5.1.2) support the design, operation, and maintenance of
equipment may include, but is not limited to, the
(b) Welding, Inspection, and Examination Qualification
following:
Documentation (not required for standard fittings, valves,
(a) material handling procedures
and components unless specifically required by the
(b) mechanical and electropolishing procedures
owner/user)
(c) shop passivation procedures
(1) Welding Procedure Specifications/Parameters
(WPS/P) GR-5.3 Material Test Reports/Certificates of
(2) Procedure Qualification Records (PQRs) Compliance
(3) Welder Performance Qualifications (WPQs) GR-5.3.1 Metallic Materials. The combination of
(4) Welding Operator Performance Qualifications documents, including Certificates of Compliance (C of
(WOPQs) Cs) and Material Test Reports (MTRs), for all valves and
(5) Examiner qualifications fittings having process contact surfaces shall include the
(6) documentation of approval of the above by the following information, as a minimum:
owner/users representative prior to welding (a) ASME BPE Standard, including year date
(7) Inspector qualifications (b) material type
(8) documentation of the approval of (c) heat number/code traceable to the MTR
para. GR-5.2.1.1.1(b)(7) by the owner/user prior to (d) chemical composition
welding (e) AWS classification of filler metal, if used

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(f) alloy designation and material specification of GR-5.3.3 Electropolishing. The electropolishing
insert, if used vendor, if requested by the owner/user, shall provide a
(g) postweld heat treatment documentation, if Certificate of Compliance with each type of compo-
applicable nent(s) that shall include, but is not limited to, the
(h) mechanical properties are not required, but if following:
included, must be accurate to the raw material (a) vendors company
specification (b) owner/users name
MTRs for other components made to a material speci- (c) description of component(s)
fication shall contain the minimum information speci- (d) identification of the electropolishing procedure
fied by the material specification incorporated by used
reference. (e) final surface finish report (Ra if required by the
GR-5.3.2 Polymeric and Other Nonmetallic Material owner/user)
Components. The manufacturer of polymeric and other GR-5.3.4 Passivation. The passivation provider
nonmetallic components shall issue a Certificate of shall supply a Certificate of Compliance for each system
Compliance that the components meet requirements as or set (type) of component(s) that shall include, but not
shown in Table PM-2.2.1-1. be limited to, the following:
GR-5.3.2.1 Seal Documentation. Seal manufactur- (a) owner/users name
ers shall provide, upon owner/user request, documenta- (b) description of system or component(s)
tion (test report) of the USP <88> Biological Reactivity (c) service providers company name
Test In Vivo, Class VI and the USP <87> Biological (d) qualified passivation method used
Reactivity Test In Vitro testing on final manufactured (e) documentation of passivation process, as follows:
seals. (1) written qualified procedure
A Certificate of Compliance shall be issued by the (2) documentation of process control of essential
seal manufacturer to certify compliance to this Standard variables
when required by the owner/user. Additional (3) instrument calibration records
agreements may be required; refer to SD-2.4.1.2(b). At (4) certificates of analysis for all chemicals used
a minimum, seals exposed to process contact fluids and/ (5) process testing and verification
or that have a high probability of exposure will comply (f) postpassivation verification method(s) used
to the United States Pharmacopeia USP <87> (or (g) for material manufacturers/suppliers of compo-
ISO 10993-5) and USP <88> Class VI (or ISO 10993-6, nents whose surfaces have been electropolished and/or
ISO 10993-10, and ISO 10993-11) [see SG-3.3.1(a)]. Exam- passivated, a Certificate of Compliance for Passivation
ples of seals coming in direct contact with a product and/or Electropolishing stating that standard industry
stream include gaskets, O-rings, valve diaphragms, practices, such as ASTM A967 or ASTM B912, as applica-
pinch tubes, and valve stem seals. ble, have been used. If required by the owner/user, the
The Certificate of Compliance shall contain the follow- manufacturer or supplier may be required to demon-
ing information: strate the effectiveness of their procedure by a method
(a) manufacturers name. mutually agreed upon.
(b) part number.
(c) lot number. GR-5.4 Weld Log
(d) material of construction. The results of the welding, examination, and inspec-
(e) compound number or unique identifier. tion shall be recorded on a Weld Log. The information
(f) cure date or date of manufacture. required to be on the Weld Log may be in any format,
(g) intrusion category (hygienic seals only; see written or tabular, to fit the needs of the manufacturer/
SG-4.2). supplier, installing contractor, inspection contractor, and
(h) compliance to USP <87> (or ISO 10993-5) and owner/user as long as all required information is
USP <88> Class VI (or ISO 10993-6, ISO 10993-10, and included or referenced. Form WL-1 (see Nonmandatory
ISO 10993-11). Appendix B) has been provided as a guide for the Weld
(i) packaging and storage recommendation. (This Log. This form includes the required data plus some
may be of another document and not a Certificate of other information that is not required. The minimum
Compliance.) Marking on the seal package should requirements are as follows:
include items (a) through (h) above. (a) isometric drawing number (including revision
GR-5.3.2.2 Sealed Unions. The seal manufacturer number)
shall provide, upon request of the owner/user, a certifi- (b) weld number
cate of design conformance that the sealed union meets (c) date welded
the intrusion requirements of SG-4.2. (d) welder and/or welding operator identification

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(e) size AWS B2.4, Specification for Welding Procedure and


(f) examination Performance Qualification for Thermoplastics
(1) date AWS G1.10M, Guide for the Evaluation of Hot Gas, Hot
(2) type of examination Gas Extrusion, and Heated Tool Butt Thermoplastic
(3) acceptance/rejection Welds
(4) initials Publisher: American Welding Society (AWS), 8669 NW
(g) inspection 36 Street, No. 130, Miami, FL 33166 (www.aws.org)
(1) date
ASME B31.3, Process Piping
(2) type of examination
ASME B46.1, Surface Texture (Surface Roughness,
(3) acceptance/rejection
Waviness, and Lay)
(4) initials
ASME Boiler and Pressure Vessel Code, Section V,
(h) identification of blind welds
Nondestructive Examination
(i) identification of manual welds
ASME Boiler and Pressure Vessel Code, Section VIII,
(j) basis of rejection Rules for Construction of Pressure Vessels
In addition, heat numbers (or other identification sys-
ASME Boiler and Pressure Vessel Code, Section IX,
tem for material traceability) and slope shall be recorded
Welding, Brazing, and Fusing Qualifications
on the Weld Log, an isometric drawing, or other owner/
ASME PTC 19.3 TW, Thermowell Design Standard
user-approved document.
Publisher: The American Society of Mechanical
GR-5.5 Records Retention Engineers (ASME), Two Park Avenue, New York, NY
10016-5990; Order Department: 22 Law Drive, Box
GR-5.5.1 Vessel Documentation. For all 2900, Fairfield, NJ 07007-2900 (www.asme.org)
Bioprocessing ASME Code-stamped vessels, National
Board registration is recommended to maintain vessel Material specifications for metallic materials are listed
data on file. Manufacturing documentation shall be by product form in Part MM.
maintained throughout the design and manufacture for
ASTM A380, Practice for Cleaning, Descaling, and
each component, assembly, part, or unit.
Passivation of Stainless Steel Parts, Equipment, and
All documentation shall be retained by the owner/
Systems
user. As agreed to by the owner/user and manufacturer,
ASTM A967, Standard Specification for Chemical
documentation from the manufacturer will be retained
Passivation Treatments for Stainless Steel Parts
for the agreed-upon duration of time but not less than
ASTM B912, Standard Specification for Passivation of
3 yr after manufacture.
Stainless Steels Using Electropolishing
GR-5.5.2 Welding Documentation ASTM D395, Standard Test Methods for Rubber
(a) Piping and Tubing. Records and retention of records Property Compression Set
associated with piping and tubing shall be in accordance ASTM D412, Standard Test Methods for Vulcanized
with ASME B31.3. Rubber and Thermoplastic Elastomers Tension
(b) Pressure Vessels and Tanks. Records and retention ASTM D471, Standard Test Method for Rubber
of records for code vessels shall be in accordance with Property Effect of Liquids
ASME BPVC, Section VIII. ASTM D624, Standard Test Method for Tear Strength of
Conventional Vulcanized Rubber and Thermoplastic
Elastomers
(14) GR-6 U.S. CUSTOMARY AND SI UNITS ASTM D2240, Standard Test Method for Rubber
This Standard uses standard units listed in Mandatory Property Durometer Hardness
Appendix II. Nonmandatory Appendix T has been pro- ASTM D2657, Standard Practice for Heat Fusion Joining
vided as a guide for U.S. Customary and SI unit of Polyolefin Pipe and Fittings
conversion. ASTM E112, Test Methods for Determining Average
Grain Size
ASTM E220, Standard Test Method for Calibration of
(14) GR-7 REFERENCES Thermocouples By Comparison Techniques
ASTM E230/E230M, Standard Specification and
For this Standard, the most recent approved version
Temperature-Electromotive Force (emf) Tables for
of the following referenced standards shall apply:
Standardized Thermocouples
ANSI/AWS A3.0, Standard Welding Terms and ASTM E644, Standard Test Methods for Testing
Definitions Industrial Resistance Thermometers
ANSI/AWS QC1, Standard for AWS Certification of ASTM E1137/E1137M, Standard Specification for
Welding Inspectors Industrial Platinum Resistance Thermometers

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

ASTM E2500, Standard Guide for Specification, Design, validation, and routine control of a sterilization pro-
and Verification of Pharmaceutical and cess for medical devices
Biopharmaceutical Manufacturing Systems and Publisher: International Organization for
Equipment Standardization (ISO) Central Secretariat, 1, ch. de la
Publisher: American Society for Testing and Materials Voie-Creuse, Case postale 56, CH-1211, Gene`ve 20,
(ASTM International), 100 Barr Harbor Drive, Switzerland/Suisse (www.iso.org)
P.O. Box C700, West Conshohocken, PA 19428-2959
ISPE Baseline Pharmaceutical Engineering Guide for
(www.astm.org)
Water and Steam Systems Volume 4
European Hygienic Engineering & Design Group Publisher: International Society for Pharmaceutical
(EHEDG), Document No. 18 Passivation of Engineering (ISPE), 3109 W. Dr. Martin Luther King,
Stainless Steel Jr. Blvd., Tampa, FL 33607 (www.ispe.org)
Publisher: European Committee for Standardization
(CEN), Avenue Marnix 17, B-1000, Brussels, Belgium NIH (BL-1/BL-4), Biohazard Containment Guidelines
(www.cen.eu) Publisher: National Institutes of Health (NIH), 9000
Rockville Pike, Bethesda, MD 20892 (nih.gov)
DVS 2202-1, Imperfections in Thermoplastic Welding
Joints; Features, Descriptions, Evaluation Recommended Practice (RP) No. SNT-TC-1A, Personnel
Publisher: DVS-Verlag GmbH (German Welding Qualification and Certification in Nondestructive
Society), Aachener Strasse 172, D-40223 Dusseldorf, Testing
Germany (dnb.ddb.de) Publisher: American Society for Nondestructive Testing
(ASNT), 1711 Arlingate Lane, P.O. Box 28518,
FDA, 21 CFR, Parts 210 and 211, Current Good Columbus, OH 43228-0518 (www.asnt.org)
Manufacturing Practices
GMP: current Good Manufacturing Practices, Title 21 of 3-A, Sanitary Standards
the Food and Drug Administration Publisher: 3-A Sanitary Standards, Inc., 6888 Elm Street,
Publisher: U.S. Food and Drug Administration (U.S. Suite 2D, McLean, VA 22101 (www.3-a.org)
FDA), 5600 Fishers Lane, Rockville, MD 20857
(www.fda.gov)
GR-8 TERMS AND DEFINITIONS (14)
IEC 60751, Industrial Platinum Resistance
annealing: a treatment process for steel for reducing hard-
Thermometers and Platinum Temperature Sensors
ness, improving machinability, facilitating cold working,
Publisher: International Electrotechnical Commission or producing a desired mechanical, physical, or other
(IEC), 3, rue de Varembe, Case postale 131, CH-1211 property.
Gene`ve 20, Switzerland/Suisse (www.iec.ch)
anomaly: a localized surface area that is out of specifica-
ISO 34-1, Rubber, vulcanized or thermoplastic tions to the surrounding area, and is classified as
Determination of tear strength Part 1: Trouser, angle abnormal.
and crescent test pieces
arc gap: for orbital GTAW, the nominal distance, mea-
ISO 34-2, Rubber, vulcanized or thermoplastic
sured prior to welding, from the tip of the electrode to
Determination of tear strength Part 2: Small (Delft)
the surface of the weld joint or insert.
test pieces
ISO 37, Rubber, vulcanized or thermoplastic arc strike: a discontinuity consisting of any localized
Determination of tensile stressstrain properties remelted metal, heat-affected metal, or change in the
ISO 48, Rubber, vulcanized or thermoplastic surface profile of any part of a weld or base metal
Determination of hardness (hardness between 10 resulting from an arc, generated by the passage of electri-
IRHD and 100 IRHD) cal current between the surface of the weld or base mate-
ISO 815-1, Rubber, vulcanized or thermoplastic rial and a current source, such as a welding electrode,
Determination of compression set Part 1: At ambi- magnetic particle prod, or electropolishing electrode.
ent or elevated temperatures aseptic: free of pathogenic (causing or capable of causing
ISO 815-2, Rubber, vulcanized or thermoplastic disease) microorganisms.
Determination of compression set Part 2: At low
temperatures aseptic processing: operating in a manner that prevents
ISO 816, Superseded by ISO 34-2 contamination of the process.
ISO 1817, Rubber, vulcanized Determination of the audit: an on-site evaluation by an ASME-appointed team
effect of liquids to review and report evidence of compliance of the appli-
ISO 11137, Sterilization of health care products cant with regard to the requirements of the ASME BPE
Radiation Part 1: Requirements for development, Standard, after issuance of a certificate.

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

autogenous weld: a weld made by fusion of the base mate- burr: excess material protruding from the edge typically
rial without the addition of filler. (See also gas tungsten- resulting from operations such as cutting or facing.
arc welding.) butt joint: a joint between two members lying approxi-
automatic welding: welding with equipment that per- mately in the same plane.
forms the welding operation without adjustment of the cartridge seal: a self-contained seal assembly.
controls by a welding operator. The equipment may or
may not perform the loading and unloading of the work. cavitation: a condition of liquid flow where, after vapor-
(See also machine welding.) ization of the liquid, the subsequent collapse of vapor
bubbles can produce surface damage.
barrier fluid: a fluid used to separate environment from
certificate: a Certificate of Authorization issued by
product such as water or condensate in a double
ASME.
mechanical seal.
Certificate of Authorization: a document issued by ASME
bioburden: the number of viable contaminating orga-
that authorizes the use of an ASME BPE Symbol Stamp
nisms per product unit.
for a specified time and for a specified scope of activity.
biofilm: a film of microorganisms or cell components certificate holder: an organization holding a Certificate of
adhering to surfaces submerged in or subjected to fluid Authorization issued by the Society upon satisfactory
environments. completion of evaluation of ability to comply with the
biologics: therapeutic or diagnostic products generated requirements of this Standard.
and purified from natural sources. certification: documented testimony by qualified authori-
biopharmaceuticals: pharmaceuticals manufactured by ties that a system qualification, calibration, validation,
biotechnology methods, with the products having bio- or revalidation has been performed appropriately and
logical sources, usually involving live organisms or their that the results are acceptable.
active components. Biopharmaceuticals generally cGMPs: current Good Manufacturing Practices. Current
include recombinant proteins, (monoclonal) antibodies, design and operating practices developed by the phar-
vaccines, blood/plasma-derived products, nonrecombi- maceutical industry to meet FDA requirements as pub-
nant culture-derived proteins, and cultured cells and lished in the Code of Federal Regulations, Chapter 1,
tissues. Title 21, Parts 210 and 211.
bioprocess: technique or operation used in the manufac- chromatography: the purification of substances based on
ture and/or purification of biopharmaceuticals or other the chemical, physical, and biological properties of the
biological materials, such as products derived from molecules involved.
microbial fermentation (e.g., yeast, mold, bacteria), cell
clean: a condition achieved by removal of dirt, residues,
culture (e.g., insect, mammalian, plant), tissue culture,
detergents, or other surface contaminants.
blood, or milk fractionation.
cleaning: operations by which dirt, residues, detergents,
bioprocessing: see bioprocess.
or other surface contaminants are removed to achieve
bioprocessing equipment: equipment, systems, or facilities predetermined surface attributes.
used in the creation of products utilizing living clean-in-place (CIP): internally cleaning a piece of equip-
organisms. ment without relocation or disassembly. The equipment
blind weld (or closure weld): a weld joint by design that is cleaned but not necessarily sterilized. The cleaning is
cannot feasibly be visually inspected internally. normally done by acid, caustic, or a combination of both,
with water-for-injection (WFI) rinse.
blister (polymeric): a localized imperfection on a polymer
surface, containing a pocket of fluid. clean steam: steam free from boiler additives that may
be purified, filtered, or separated. Usually used for inci-
blistering (metallic): a localized delamination within the dental heating in pharmaceutical applications.
metal that has an appearance of chipped or flaked-off
areas. Per SEMI F019-0304, section 4.2.1. closed head: for orbital GTAW, a welding head that encap-
sulates the entire circumference of the tube/pipe during
borescope: a device for indirect visual inspection of diffi- welding and that contains the shielding gas.
cult access locations such as equipment and pipes.
cloudiness: the appearance of a milky white hue across
break: a discontinuity in the face of a fitting. some portion of a surface resulting from the
buffing: a metal finishing process for smoothing the sur- electropolish process.
face using a grease-suspended abrasive. cluster of pits: two or more pits, the closest distance
burn-through: excessive melt-through or a hole through between each being less than the diameter of any one pit.
the root bead of a weld. cluster porosity: porosity that occurs in clumps or clusters.

10

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

compendial water: purported to comply with USP and/ demarcation: a localized area that is dissimilar to the
or any other acknowledged body of work related to surrounding areas with a defined boundary.
the quality, manufacture, or distribution of high purity dent: a large, smooth-bottomed depression whose diam-
water. eter or width is greater than its depth and that will not
compression set: permanent deformation of rubber after produce an indication.
subscription in compression for a period of time, as descaling: the removal of heavy, tightly adherent oxide
typically determined by ASTM D395. films resulting from hot-forming, heat-treatment, weld-
concavity: a condition in which the surface of a welded ing, and other high-temperature operations such as in
joint is depressed relative to the surface of the tube or steam systems.
pipe. Concavity is measured as a maximum distance dirty: a relative term indicating the condition of being
from the outside or inside diameter surface of a welded contaminated.
joint along a line perpendicular to a line joining the discoloration: any change in surface color from that of
weld toes. the base metal. Usually associated with oxidation
consumable insert: a ring of metal placed between the occurring on the weld and heat-affected zone on the
two elements to be welded that provides filler for the outside diameter and inside diameter of the weld joint
weld, when performed with fusion welding equipment. as a result of heating the metal during welding. Colors
A consumable insert can also be used for the root pass may range from pale bluish-gray to deep blue, and from
in a multiple pass weld with the addition of filler wire pale straw color to a black crusty coating.
(also called insert ring). discontinuity: interruption of the typical structure of a
convexity: a condition in which the surface of a welded weldment, such as a lack of homogeneity in the mechani-
joint is extended relative to the surface of the tube or cal, metallurgical, or physical characteristics of the mate-
pipe. Convexity is measured as a maximum distance rial or weldment. A discontinuity is not necessarily a
from the outside or inside diameter surface of a welded defect.
joint along a line perpendicular to a line joining the distribution system: centralized system for the delivery
weld toes. of fluids from point of generation or supply to point
corrosion: a chemical or electrochemical interaction of use.
between a metal and its environment, which results in downslope: that part of an automatic orbital weld
changes in the property of the metal. This may lead to sequence during which the welding current is gradually
impairment of the function of the metal, the environ- reduced prior to extinguishing of the welding arc. The
ment, and/or the technical system involved. downslope portion of a welded joint is seen as a tapering
cracks: fracture-type discontinuities characterized by a of the end of the weld bead with a reduction of penetra-
sharp tip and high ratio of length and width to opening tion from the beginning to the end of the downslope so
displacement. A crack may not be detected with a stylus. that the final weld bead is small with minimal
A linear crack will produce a liquid penetrant indication penetration.
during liquid penetration inspection, X-ray, or dross: a concentration of impurity formed in the weld
ultrasound. puddle. It floats to the surface when the metal solidifies.
crater: a depression at the termination of a weld bead. (See also slag.)
duplex stainless steel: a group of stainless steels whose
crater cracks: cracks that form in the crater, or end, of
chemical composition is designed to produce a room-
the weld bead.
temperature microstructure that is a mixture of austenite
creep: a time-dependent permanent deformation that and ferrite.
occurs under stress levels below the yield stress.
durometer: measurement of hardness related to the resist-
dead leg: an area of entrapment in a vessel or piping run ance to penetration of an indenter point in to a material
that could lead to contamination of the product. as typically determined by ASTM D2240.
defects: discontinuities that by nature or accumulated dynamic seal: seal with a component that is in motion
effect (for example, total crack length) render a part or relative to a second surface.
product unable to meet minimum applicable acceptable dynamic spray device: a moving device, designed to pro-
standards or specifications. This term designates reject- duce a nonstationary spray pattern.
ability. (See also discontinuity.)
elastomer: rubber or rubberlike material possessing elas-
deionized water: a grade of purified water produced by ticity. (See also elastomeric material.)
the exchange of cations for hydrogen ions and anions elastomeric material: a material that can be stretched or
for hydroxyl ions. compressed repeatedly and, upon immediate release of
delamination: separation into constituent layers. stress, will return to its approximate original size.

11

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

electropolishing: a controlled electrochemical process uti- or gas mixture. (This process is sometimes called TIG
lizing acid electrolyte, DC current, anode, and cathode welding, a nonpreferred term.) GTAW may be per-
to smooth the surface by removal of metal. formed by adding filler material to the weld, or by a
end grain effect: a surface discontinuity of small diameter fusion process in which no filler is added.
(or linear) cavities located perpendicular to the rolling gasket: static seal made from deformable material com-
direction of the material and appearing after pressed between two mating surfaces.
electropolishing.
GMP facility: a facility designed, constructed, and oper-
etching: the process of removing a layer of metal from ated in accordance with cGMP guidelines established
its surface using a chemical and/or electrolytic process. by the FDA.
ethical pharmaceutical: a controlled substance for the diag- grain boundary: an interface separating two grains, where
nosis or treatment of disease. the orientation of the lattice structure changes from that
excessive penetration: weld penetration that exceeds the of one grain to that of the other. Per SEMI F019-0304,
acceptance limit for inside diameter convexity. (See also section 4.8.2
convexity.)
harvesting: the separation of cells from growth media.
expiration date: the date after which the shelf life has This can be accomplished by filtration, precipitation, or
been exceeded. centrifugation.
extractables (polymeric): chemicals that can be removed haze: a localized diminished surface brightness, com-
from polymeric articles using appropriate solvents. monly produced by gassing or air pockets, during
fermentation: the biochemical synthesis of organic com- electropolishing.
pounds by microorganisms or cultivated cells. heat-affected zone: that portion of the base metal or poly-
fermentor (fermenter): a vessel for carrying out mer that has not been melted, but whose microstructure
fermentation. or mechanical properties have been altered by the heat
fixture marks: an area on an electropolished component of welding or cutting.
where the electrical connection was made for the pro- heat number: an alphanumeric identification of a stated
cessing of the component. tonnage of metal obtained from a continuous melting
flash electropolish: an electrochemical process done for a in a furnace.
very short duration of time with a low current density, heat tint: coloration of a metal surface through oxidation
which neither significantly alters the surface of the mate- by heating. (See also discoloration.)
rial nor meets the acceptance criteria as set forth in
Table H-3.3-1 in Nonmandatory Appendix H of this higher alloy: a metal containing various alloying constit-
Standard. uents formulated to provide enhanced corrosion resist-
ance and possibly improved mechanical properties
fluoropolymer: polymer material having a carbon chain beyond those that are typically observed in UNS S31603
either partially or completely bonded to fluorine atoms.
stainless steel.
flushing (rinsing): the flowing of water over the product
hold-up volume: the volume of liquid remaining in a ves-
and/or solution contact surfaces of system components
sel or piping system after it has been allowed to drain.
for the removal of particulates or water soluble
contaminants. hydrotest: a pressure test of piping, pressure vessels, or
full penetration: a weld joint is said to be fully penetrated pressure-containing parts, usually performed by pres-
when the depth of the weld extends from its face into surizing the internal volume with water at a pressure
the weld joint so that the joint is fully fused. For a tube- determined by the applicable code.
to-tube weld, no unfused portions of the weld joint shall hygienic: of or pertaining to equipment and piping sys-
be visible on the inside diameter of a fully penetrated tems that by design, materials of construction, and oper-
weld. ation provide for the maintenance of cleanliness so that
fusion: the melting together of filler metal and base metal, products produced by these systems will not adversely
or of base metal only, that results in coalescence. affect human or animal health.
fusion welding: welding in which the base material is hygienic clamp joint: a tube outside diameter union con-
fused together without the addition of filler material to sisting of two neutered ferrules having flat faces with
the weld. (See also gas tungsten-arc welding.) a concentric groove and mating gasket that is secured
gas tungsten-arc welding (GTAW): an arc welding process with a clamp, providing a nonprotruding, recessless pro-
that produces coalescence of metals by heating them cess contact surface.
with an arc between a tungsten (nonconsumable) elec- hygienic joint: a tube outside diameter union providing
trode and the work. Shielding is obtained from a gas a nonprotruding, recessless process contact surface.

12

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

icicles: localized regions of excessive penetration, which manual welding: welding in which the entire welding
usually appear as long, narrow portions of weld metal operation is performed and controlled by hand.
on the weld underbead. (See also convexity and excessive
material manufacturer: the organization responsible for
penetration.)
the production of products meeting the requirements of
inclusions: particles of foreign material in a metallic or the material specification and accepting the responsibil-
polymer matrix. ity for any statements or data in any required certificate
incomplete fusion (or lack of fusion): a weld discontinuity of compliance or material test report representing the
in which fusion did not occur between weld metal and material.
faces or between adjoining weld beads. Also, in welding material test report (mill test report or MTR): a document
of tubing, when the weld fully penetrates the wall thick- in which the results of tests, examinations, repairs, or
ness but misses the joint, leaving some portion of the treatments required by the material specification to be
inner (inside diameter) weld joint with unfused edges. reported are recorded. This document includes those of
incomplete penetration (or lack of penetration): a groove any supplementary requirements or other requirements
weld in which the weld metal does not extend com- stated in the order for the material. This document may
pletely through the joint thickness. be combined with a certificate of compliance as a single
document. When preparing a material test report, a
indication: a condition or an anomaly of a localized area material manufacturer may transcribe data produced by
that has not been classified as being accepted or rejected. other organizations, provided he accepts responsibility
Inspectors Delegate: a person who is delegated by an for the accuracy and authenticity of the data.
owners inspector to perform inspection functions as material type: a commercial designation for a given chem-
referenced in ASME B31.3, para. 340.4(c). istry range.
joint penetration: the depth that a weld extends from its maximum working pressure: the pressure at which the
face into a joint, exclusive of reinforcement. system is capable of operating for a sustained period
lack of fusion after reflow: a discontinuity in welding of of time.
tubing where, after a reflow or second weld pass has maximum working temperature: the temperature at which
been made, the original joint has still not been con- the system must operate for a sustained period of time.
sumed, leaving the weld joint with unfused edges on The maximum working temperature should relate to
the inner surface. the maximum working pressure and the fluids involved.
lamellar tears: terrace-like fractures in the base metal with meandering: of or pertaining to a weld bead that deviates
a basic orientation parallel to the wrought surface; from side to side across the weld joint rather than
caused by the high stress in the thickness direction that tracking the joint precisely.
results from welding.
mechanical polishing: a process by which abrasive media
laminations: elongated defects in a finished metal prod- is applied to a surface with intent to smoothen until a
uct, resulting from the rolling of a welded or other part desired and/or specified surface roughness (R a ) is
containing a blowhole. Actually, the blowhole is achieved.
stretched out in the direction of rolling.
mechanical seal: a device used for sealing fluids with
leachables (polymeric): typically a subset of extractables,
rotating shafts. A mechanical seal is a prefabricated or
these chemicals migrate from polymeric articles into the
packaged assembly that forms a running seal between
product or process fluid.
flat surfaces.
linear porosity: porosity that occurs in a linear pattern.
micron (1 ) or micrometer (1 m): one-millionth of a
Linear porosity generally occurs in the root pass from
meter.
inadequate joint penetration.
misalignment (mismatch): axial offset of the joint
liquid penetrant indication: refer to ASME BPVC,
members.
Section V, Article 6, para. T-600, for testing an anomaly
or an indication. miter: two or more straight sections of tube matched and
joined in a plane bisecting the angle of junction so as
luster: the state or quality of shining by reflecting light.
to produce a change of direction.
(See also variance in luster.)
mold flash: excess material that is greater than the
machine welding: welding with equipment that performs
designed geometry of a part that is formed in the mold-
the welding operation under the constant observation
ing process.
and control of a welding operator. The equipment may
or may not perform the loading and unloading of the molded seal: a seal that is manufactured by forming in a
works. (See also automatic welding.) mating cavity.

13

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

nick: a surface void anomaly caused by material removal passivity: the state in which a stainless steel exhibits a
or compression from the surface, whose bottom surface very low corrosion rate. The loss (or minimizing) of
is usually irregular. chemical reactivity exhibited by certain metals and
nominal outside diameter: a numerical identification of alloys under special environmental conditions.
outside diameter to which tolerances apply. PE: polyethylene, polymer material composed of carbon
and hydrogen.
nominal wall thickness: a numerical identification of wall
thickness to which tolerances apply. penetration: see full penetration, incomplete penetration, and
joint penetration.
nonuniform mechanical polishing marks: a localized surface
polishing pattern that is dissimilar to the surrounding personal care products: products used for personal hygiene
area. or cosmetic care.
off angle: a measurement of face-to-face squareness. PFA: perfluoroalkoxy, copolymer of perfluoroalkoxy and
tetrafluoroethylene.
off plane: a measurement of the offset between part cen-
terlines or two planes. pharmaceutical: relating to the use and/or manufacture
of medical drugs or compounds used to diagnose, treat,
open head: for orbital GTAW, a welding head that is open or prevent a medical condition.
to the atmosphere external to the tube/pipe being
welded and that does not enclose the shielding gas, pickling: a chemical process for cleaning and descaling
which is still provided through the torch. stainless steel and other alloy parts, equipment, and
systems.
orange peel: an appearance of a pebbly surface.
pipe: pipe size is determined by diameter and either
orbital welding: automatic or machine welding of tubes schedule, series, or SDR. For bioprocessing equipment,
or pipe in-place with the electrode rotating (or orbiting) pipe does not include tube.
around the work. Orbital welding can be done with the
addition of filler material or as a fusion process without pit: a small surface void resulting from a localized loss
the addition of filler. of base material.

O-ring: ring seal of circular cross section. pitch: to cause to be set at a particular angle or slope.
Degree of slope or elevation.
outboard seal: a seal that is outside the product area in
polymer: a molecule consisting of many smaller groups.
the outermost part of a mechanical seal assembly.
They can be synthesized either through chain reactions
overlap: the protrusion of weld metal beyond the weld or by templating. Some examples of polymers are plas-
toes or weld root. Also, in an orbital weld, that amount tics, proteins, DNA, and dendrimers.
by which the end of the weld bead overlaps the begin-
polymeric materials: a natural or synthetic material whose
ning of the weld bead (not including the downslope)
molecules are linked in a chain.
on a single-pass weld.
polypropylene (PP): polymer material composed of car-
owner/user: the body upon which final possession or
bon and hydrogen.
use rests.
porosity: cavity-type discontinuities formed by gas
oxidation: a common form of electrochemical reaction entrapment during solidification.
that is the combining of oxygen with various elements
and compounds. pressure rating: pressure at which a system is designed
to operate, allowing for applicable safety factors.
oxide layer: an area usually located in the heat-affected
zone of the weldment where an oxidation reaction has process component: a component that contacts the product
taken place. or process fluid. Process components include, but are
not limited to piping, fittings, gaskets, vessels, valves,
packing: a type of shaft seal formed into coils, spirals, or pumps, filter housings, and instruments.
rings that is compressed into the seal cavity.
process contact surface: a surface under design operating
passivation: removal of exogenous iron or iron from the conditions that is in contact with, or has the potential
surface of stainless steels and higher alloys by means to be in contact with, raw materials, in-process materials,
of a chemical dissolution, most typically by a treatment APIs, clean utilities (e.g., WFI, CIP, pure steam, process
with an acid solution that will remove the surface con- gases), or components (e.g., stoppers) and where there
tamination and enhance the formation of the passive is a potential for the surface to affect product safety,
layer. quality, identity, strength, or purity.
passive layer: a chromium-enriched oxide layer on a stain- product contact surface: a process contact surface that is
less steel surface, that improves the corrosion resistance in contact with, or has the potential to be in contact
of the base metal. with, a product where product is defined by the

14

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

owner/user. Examples of product contact surfaces may of filler material. A sanitary weld must be completely
include the interior surfaces of bioreactors, transfer tub- penetrated on the weld I.D., with little or no discolor-
ing, chromatography columns, vessels, and recirculating ation due to oxidation, and be otherwise without defects
segments of CIP systems. that would interfere with maintenance in a clean and
profilometer: an instrument for the measurement of the sterile condition.
degree of surface roughness. schedule: dimensional standard for pipe as defined by
progressive polishing: a mechanical grinding procedure ASTM.
where a coarse grit material is used first and the succes- SDR: standard dimension ratio, a sizing system for poly-
sive operations use a finer and finer grit until the desired mer piping systems that relates wall thickness to pres-
surface roughness is achieved. sure rating as defined by ISO.
PTFE: polytetrafluoroethylene, homopolymer material seal chamber: see stuffing box.
of tetrafluoroethylene. seal face: surface point on which a seal is achieved.
pure steam: steam that is produced by a steam generator seal point: location of process boundary created by com-
that, when condensed, meets requirements for water- ponents in contact (seal), having sufficient contact
for-injection (WFI). stress/load to create media or environmental isolation.
purified water (PW): a classification of water according seal weld: a weld used to obtain fluid tightness as
to compendial standards. opposed to mechanical strength.
PVDF: polyvinylidene fluoride, homopolymer, and/or self-draining: the elimination of all fluid from the system
copolymer material composed of carbon, hydrogen, and due to the force of gravity alone.
fluorine.
SEM: scanning electron microscope.
pyrogen: a fever-producing substance.
semi-automatic arc welding: arc welding with equipment
Ra: log of the arithmetic mean of the surface profile. that controls only the filler metal feed. The advance of
Ra max.: the highest value of a series of Ra readings. the welding is manually controlled.
reflow: a second weld pass made to correct a lack of service life: the life expectancy or number of cycles for
fusion or missed joint. which the unit will maintain its performance.
reinforcement: see convexity. shelf life: the duration, under specified storage condi-
tions, from the date of manufacture to the last date
rouge: a general term used to describe a variety of discol-
the product can be placed in service without having an
orations in high purity stainless steel biopharmaceutical
unacceptable effect on performance.
systems. It is composed of metallic (primarily iron)
oxides and/or hydroxides. Three types of rouge have significant change (polymeric): a change that may affect
been categorized. form, fit, or function.
Class I rouge: a rouge that is predominantly particulate size classification: the size of surface deficits is classified
in nature. It tends to migrate downstream from its origi- in two groups: macro, referring to indications that can
nation point. It is generally orange to red-orange in color. be seen in adequate lighting without magnification, and
These particles can be wiped off a surface and are evident micro, referring to indications that can be seen only with
on a wipe. Surface composition of the stainless steel the aid of magnification.
under the rouge remains unchanged.
slag: a concentration of nonmetallic impurities (often
Class II rouge: a localized form of active corrosion. It
oxides or nitrides) that forms in the weld pool and solidi-
occurs in a spectrum of colors (orange, red, blue, purple,
fies on the underbead or weld top surface. Sometimes
gray, black). It can be the result of chloride or other
referred to as dross.
halide attack on the surface of the stainless steel.
Class III rouge: a surface oxidation condition occurring slope: an incline or deviation from the horizontal. A tube
in high temperature environments such as pure steam or pipe installed in the horizontal plane is said to slope
systems. The systems color transitions to gold, to blue, if one end is positioned higher than the other.
to various shades of black, as the layer thickens. This sparger: a device used to agitate, oxygenate, or aerate a
surface oxidation initiates as a stable layer and is rarely liquid by means of compressed air or gas.
particulate in nature. It is an extremely stable form of spatter: the metal particles expelled during welding that
magnetite (iron sesquioxide, Fe3O4). do not form part of a weld.
sanitary: see hygienic. spot electropolishing: a localized electrochemical process
sanitary (hygienic) weld: generally considered to be a that is capable of producing the correct Cr to Fe ratios on
groove weld in a square butt joint made by the GTAW (or the surface of a material and meeting the requirements of
plasma) process as a fusion weld without the addition Table H-3.3-1.

15

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

spray device: device for the directed distribution (deliv- system volume: total volume of liquid in the system,
ery) of liquids to defined process contact surfaces of including equipment, piping, valving, and
equipment. (See also static spray device and dynamic spray instrumentation.
device.) thermoplastic: long-chain polymers that are usually not
square cut: a tube end cut perpendicular to the tangent connected by crosslinks. Once formed, these materials
plane. can be reshaped.
squareness: face-to-face perpendicularity. thermoset: long-chain polymers that are usually con-
nected by crosslinks. Once formed, these materials can-
static seal: a stationary sealing device. not be reshaped.
static spray device: a stationary device, designed to pro- transfer panel: a panel to which process and/or utilities
duce a fixed directional spray pattern. are piped that mechanically precludes erroneous cross-
connections.
steam-in-place (SIP): the use of steam to sanitize or steril-
ize a piece of equipment without the use of an autoclave. tube: tube is sized by its nominal outside diameter. For
bioprocessing equipment, tube does not include pipe.
stem seal: a seal element that is used on a shaft.
tungsten inclusions: tungsten particles transferred into
sterile: free from living organisms. the weld deposit by occasional touching of the tungsten
sterility: the absence of all life forms. electrode used in the gas tungsten-arc process to the
work or to the molten weld metal. These inclusions are
stringer indication: a linear void resulting from the often considered defects that must be removed and the
removal of an elongated nonmetallic inclusion or sec- weld repaired prior to final acceptance. Tungsten inclu-
ondary phase. sions may be invisible to the unaided eye, but are readily
stuffing box: in shaft seals, the casing containing the seal- identified in a radiograph.
ing material. Seal chamber for shaft seals. (See also unacceptable leakage: leakage level above which the sys-
packing.) tem performance is considered unacceptable by the sys-
tem user and applicable regulating body.
super-austenitic stainless steel: a subgroup of austenitic
stainless steels having elevated levels of nickel, chro- undercut: a groove melted into the base metal adjacent
mium, and molybdenum compared with standard aus- to the weld toe or weld root and left unfilled by weld
tenitic stainless steels (e.g., UNS S31603) and that may metal.
have other additions (e.g., nitrogen and/or copper) to underfill: a depression on the weld face or root surface
increase strength and resistance to pitting corrosion and extending below the adjacent surface of the base metal.
stress corrosion cracking in the presence of chlorides. (See also concavity.)
super duplex stainless steel: those duplex stainless steels uniformly scattered porosity: porosity that is distributed
whose chemical composition is designed to result in a in a weldment in a uniform pattern.
pitting resistance equivalent number (PREN) of at user: see owner/user.
least 40. validation: establishing documented evidence that the
surface finish: all surfaces as defined by Part SF of the system does what it purports to do.
current ASME BPE Standard and/or the owner/user or variance in luster: the appearance of a different shine or
manufacturer and referred in Ra inches or meters. reflectivity resulting from the examination or inspection
surface inclusion: particles of foreign material in a metallic technique or from the preconditioning or conditioning
matrix. The particles are usually compounds such as of the electropolished surface.
oxides, sulfides, or silicates, but may be a substance waviness: undulations or rippling of the surfaces.
foreign to and essentially insoluble in the matrix. weld joint design: the shape, dimensions, and configura-
surface residual: a foreign substance that adheres to a tion of the weld joint.
surface by chemical reaction, adhesion, adsorption, or weld whitening: a difference in appearance of grain struc-
ionic bonding (e.g., corrosion, rouging, and staining). ture between weld metal and base metal after
electropolishing.
survey: an announced on-site evaluation by an ASME
appointed team to review and report evidence of compli- welding operator: one who operates machine or automatic
ance of the applicant with regard to the requirements welding equipment.
of the ASME BPE Standard before issuance or renewal WFI: water-for-injection, a classification of water
of a certificate. according to compendial standards.

16

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Part SD
Systems Design

(14) SD-1 PURPOSE AND SCOPE SD-2.3 Bioburden Reduction


The purpose of Part SD is to establish design guide- [Reserved for future content]
lines applicable to bioprocessing equipment. Wherever SD-2.3.1 Thermal Sanitization. [Reserved for future
equipment is stated in this Part, it shall mean all bio- content]
processing equipment, components, assemblies, and
systems. SD-2.3.1.1 Steam in Place. Equipment parts and (14)
The purpose of this Part is to provide requirements components subjected to SIP should withstand continu-
for the specification, design, fabrication, and verification ous flow of saturated steam at a minimum temperature
of process equipment and systems that are fit for of 266F (130C) for duration of 100 hr minimum under
intended use and minimize risk to product quality. continuous steady-state conditions. However, at the dis-
Part SD also provides design guidelines that should be cretion of the owner/user, conditions that are more strin-
applied at the discretion of the owner/user on the basis gent may be imposed. The use of elastomers/
of assessed risk to the product. Figures in this Part are fluoroelastomers (within a piece of equipment or certain
intended to illustrate accepted applications of general process instrumentation) that may thermally degrade
design principles and are not intended to limit alternate during SIP will need to be thoroughly evaluated by
designs. the owner/user or manufacturer. The overall life of the
The scope of Part SD encompasses requirements for equipment may be shortened significantly if the correct
equipment, process systems, and utilities that could elastomer or process instrument is not selected.
potentially impact product quality. Specific guidance is All process contact surfaces subjected to SIP shall
reach the required temperatures during the SIP cycle.
provided for bioburden control in manufacturing pro-
cesses, including design requirements for cleaning, sani- SD-2.3.1.2 Depyrogenation. [Reserved for future
tization, and/or sterilization of bioprocess systems. content]
SD-2.3.2 Chemical Sanitization. [Reserved for
(14) SD-2 GENERAL GUIDELINES future content]

All equipment and/or systems shall be designed SD-2.4 Fabrication (14)


according to the bioprocessing application, require- Fabrication shall be performed in facilities where the
ments, and specifications of the owner/user. It shall process contact surfaces are protected from contamina-
be the responsibility of the owner/user to specify the tion. During field welding and assembly, surface con-
cleaning and/or sanitization requirements of the equip- tamination shall be prevented.
ment and/or system. Systems, equipment, and components shall be cleaned
with a suitable cleaning agent and covered for protection
(14) SD-2.1 Containment before shipment. The use of preservative fluids is not
recommended.
The containment level of the system or individual
Any process contact surfaces that require shipment
pieces of equipment should be specified and communi-
with preservatives or coatings shall be
cated by the owner/user.
(a) mutually agreed to, in advance, by the owner/
The owner/user shall determine the containment
user and manufacturer
level for the particular type of equipment or system, in
(b) clearly identified to all parties
accordance with the Centers for Disease Control and
(c) in compliance with FDA or other applicable regu-
Prevention (CDC) and guidelines of the National
lations, as appropriate for the process
Institutes of Health (NIH) or directives of the European
Union and other applicable local codes or environmental SD-2.4.1 Materials of Construction
regulations.
SD-2.4.1.1 General. Generally, materials such as
316, 316L, stainless steels, duplex stainless steels, and
SD-2.2 Bioburden Control
higher alloys have proven to be acceptable. The
[Reserved for future content] owner/user shall be responsible for the selection of the

17

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

appropriate materials of construction for the specific Table SD-2.4.3.1-1 Slope Designations for
process. Metallic materials of construction are listed in Gravity-Drained Lines
Part MM. Minimum Minimum Minimum
When nonmetallic materials are used (e.g., polymeric Slope Slope, Slope, Minimum Slope,
materials or adhesives), the owner/user shall specify Designation in/ft mm/m Slope, % deg
which one of these materials shall carry a Certificate GSD1 1
/16 5 0.5 0.29
of Compliance. The conformance of material shall be GSD2 1
/8 10 1.0 0.57
explicitly stated (e.g., conforming to FDA 21CFR 177 GSD3 1
/4 20 2.0 1.15
and USP Section <88> Class VI). Polymeric materials and GSD0 Line slope not required
other nonmetallic materials of construction are listed in
Part PM.
SD-2.4.1.2 Process Compatibility (3) Fasteners or threads shall not be exposed to the
(a) Materials of construction shall be capable of with- process, steam, or cleaning fluids. The use of threads
standing the temperature, pressure, and chemical corro- within the process requires owner/user agreement.
siveness ensuring the purity and integrity of the product. Bolted attachments should be eliminated whenever
(b) Materials shall be compatible with the stated bio- possible.
processing conditions, cleaning solutions, and SIP condi- (4) No engraving or embossing of materials (for
tions, etc., as specified by the owner/user. identification or traceability reasons) should be made
(c) Surfaces exposed to bioprocessing fluids, cleaning, on the process contact side. When markings are required
and SIP conditions must be on process contact surfaces, other methods of identifica-
(1) homogeneous in nature tion shall be used.
(2) impervious (b) The following provisions are applicable to tubing,
(3) inert equipment, or systems intended to be cleaned in place:
(4) nonabsorbent (1) Internal horizontal surfaces should be
(5) nontoxic minimized.
(6) insoluble by process or cleaning fluids (2) The equipment shall be drainable and free of
(7) resistant to corrosion, scratching, scoring, and areas where liquids may be retained and where soil or
distortion contaminants could collect. The equipment shall be free
(d) Materials that are in contact with bioprocessing of areas of low flow and velocity or impact where soil
fluids shall be identified by an industry recognized or contaminants could collect.
standard (see para. MM-4). (3) Design of corners and radii should meet the
following requirements: All internal angles of 135 deg
SD-2.4.1.3 Surface Coatings. Clad or electroplated or less on surfaces shall have the maximum radius possi-
surface coatings, plating, and surface preparatory chem- ble for ease of cleanability. Where possible, these surfaces
icals may be used provided approval from the owner/ shall have radii of not less than 18 in. (3.2 mm) except
user has been obtained. All surface coatings shall remain where required for functional reasons, such as the bon-
intact and be tolerant to the process, SIP and CIP fluids, net/body connection. For special cases, the radii may
and temperatures, without peeling or cracking. be reduced to 116 in. (1.6 mm) when agreed to by the
SD-2.4.1.4 Transparent Materials owner/user. When the 116 in. (1.6 mm) radii cannot be
(a) Transparent materials (e.g., glass, polymer) that achieved for essential functional reasons such as flat
are used in viewing ports shall be rated for the applicable sealing surfaces and flow control apertures, the surfaces
pressure, temperature range, and thermal shock. of these internal angles shall be readily accessible for
(b) Internally coated glass shall only be used if the cleaning and examination.
coating complies with FDA regulations or another regu- SD-2.4.3 Drainability
latory authoritys regulations and approved by the
owner/user. SD-2.4.3.1 General. For sterility and cleaning,
gravity is an effective way to facilitate drainage. To
(14) SD-2.4.2 Cleanability achieve gravity drainage, lines should be pitched to des-
(a) The following provisions are applicable to tubing, ignated points at a specific slope. Refer to
equipment, or systems intended to be cleaned: Nonmandatory Appendix C for suggested method of
(1) All surfaces shall be cleanable. Surface imper- slope measurement. For gravity-drained piping/tubing
fections (e.g., crevices, gouges, obvious pits) shall be systems, the owner/user may define the system slope
eliminated whenever feasible. in accordance with one of the designations listed in
(2) All surfaces shall be accessible to the cleaning Table SD-2.4.3.1-1. Gravity-drained piping/tubing sys-
solutions and shall be accessible to establish and deter- tems shall have a continuous pitch that is equal to or
mine efficacy of the cleaning protocol. greater than the slope designation. Line sections up to

18

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

10 in. (25 cm) in length (or longer with advance approval SD-2.4.4.2 Exterior Design. Equipment located in
of owner/user) that are level or have a positive slope less clean areas is periodically cleaned by wash-down or
than the slope designation are acceptable if the section is manually cleaned by wipe-down with harsh cleaning
fitting-bound. solutions. Such equipment shall conform to the
following:
(14) SD-2.4.3.2 Drainability Design Considerations.
(a) Materials of construction should be corrosion
The systems process requirements should be considered
resistant, easily maintained, cleaned, and sanitized with-
in the selection of slope designation.
out flaking or shedding.
(a) Process contact lines exposed to liquid should be
(b) Finishes shall be compatible with the area/room
sloped to minimize pooling in the system.
classification as agreed to by the owner/user and
(b) Lines that are steam sterilized in-place should be
manufacturer.
sloped to facilitate gravity drainage of condensate.
(c) Components shall be capable of being chemically
(c) Lines that are cleaned in-place should be sloped cleaned, steam cleaned, or pressure washed.
to facilitate gravity drainage of cleaning fluids.
(d) All burrs or weld marks shall be removed.
The physical characteristics of the system (e.g., line
(e) Hinges should be easily removable and/or
size, materials, fluid viscosity, fluid surface tension) will
cleanable.
influence drainability at a given slope and should also
(f) Equipment mounted on cabinets that are exposed
be considered. The owner/user may apply additional
to the environment should be mounted flush.
criteria in the selection of slope designation to address
(g) Skids should have no openings in the frame
issues such as product recovery or maintenance. Fluid
allowing water retention. Supporting skid frame struc-
retention due to capillary action should be considered
tures and modules should be constructed from fully
when using tubing less than 34 in. (20 mm). System
sealed tubes or pipes, which are easily cleaned. Frames
leveling should be considered for mobile equipment that
should have rounded rather than sharp edges.
is gravity drained.
(h) Motors, gearboxes, and similar equipment should
(14) SD-2.4.3.3 Slope Considerations. The recom- not retain fluids or cleaning solutions on their external
mended minimum slope designation for gravity- surfaces.
drained process contact lines is GSD2. (i) Nameplates for tagging equipment should be con-
structed from corrosion-resistant material such as stain-
SD-2.4.3.4 Drain Points
less steel or polymeric material, and have minimum
(a) Piping and equipment should be installed with
crevices. The nameplates should be attached and sealed
designated drain points to maximize self-draining prop-
or attached with a corrosion-resistant wire loop.
erties. The number of drain points should be minimized.
(j) There should be adequate clearance below or
The equipment manufacturer shall indicate the proper
under the equipment for cleaning, and a clearance for
orientation to optimize drainability. The installer and
discharge should be provided. Elevated equipment
owner/user shall ensure that proper orientation is
under open frames should have a minimum clearance
achieved.
of 6 in. (150 mm) for wash-down and cleaning. In other
(b) Systems or equipment that cannot be gravity- cases a minimum of 4 in. (100 mm) would be adequate.
drained shall utilize forced expulsion with pressurized
(k) Joints and insulation materials shall be sealed and
gas where line drainability is required.
impervious to moisture and cleaning agents.
SD-2.4.4 Miscellaneous Design Details (l) Electrical enclosures and conduit should be cleana-
ble and utilize materials of construction that are compat-
SD-2.4.4.1 Lubricants ible with cleaning agents.
(a) Grease and other lubricating fluids that are used (m) Painted surfaces shall be identified by the fabrica-
in gear boxes, drive assemblies, etc., shall be contained tor and have the advance approval of the owner/user.
to prevent leakage of the lubricants or process, either All paint systems shall be FDA compliant.
directly or indirectly (e.g., through seepage, seal leaks,
etc.). SD-2.4.4.3 Surface Finishes. The finishes of pro- (14)
(b) The equipment manufacturer shall specify the cess contact surfaces shall be specified by the owner/
type of lubricants that are to be used for maintenance. user in accordance with the definitions of Part SF in this
If the specified lubricant is not accepted by the owner/ Standard.
user, the choice of an alternative shall be agreed to by
the owner/user and the equipment manufacturer. SD-3 PROCESS COMPONENTS
(c) The owner/user shall give his approval for the SD-3.1 Connections, Fittings, and Piping
lubricants that could come in contact with the product. SD-3.1.1 General (14)
These lubricants shall be identified by name, manufac- (a) Design of equipment should minimize the number
turer, and grade and shall conform to FDA or other of connections. Butt welded connections should be used
applicable regulatory codes. wherever practical.

19

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(b) Connections to equipment shall use acceptable The orientation of a branch is critical to the cleanability
hygienic design connections, mutually agreeable to the of the system. The branch shall be oriented to avoid a
owner/user and manufacturer. dead leg (e.g., a vertical branch with an L/D of 2 or less
(c) All connections shall be capable of CIP and SIP. may still result in a dead leg with trapped gas or residual
Fittings shall be so designed that there will not be any materials).
crevices or hard-to-clean areas around the gasketed joint. For high-purity water systems, an L/D of 2 or less is
ASME raised face or flat face flanged joints should be attainable with todays manufacturing and design tech-
avoided where possible (see Fig. SD-3.1.1-1). nology. For other bioprocessing systems, such as purifi-
(d) Ferrules and ferrule connections should be as cation, filtration, and fermentation having cluster, block,
short as possible to minimize dead legs. The use of short and multiport valves, an L/D of 2 or less is achievable.
welding ferrules should be incorporated into the design. However, it may not be achievable with certain equip-
(e) All process contact fittings exposed to liquid ment and process configurations as they are currently
should be self-draining when properly installed. manufactured. An L/D of 2 or less is recommended but
(f) Threaded fittings, exposed to process fluid, are not shall not be construed to be an absolute requirement.
recommended (see Fig. SG-2.2.2-5). The system designer and manufacturer shall make every
(g) The use of flat gaskets may be acceptable, when attempt to eliminate system branches with an L/D
agreed to by the owner/user and manufacturer, for greater than 2. It will be the responsibility of the system
applications where it is considered self-sanitizing (i.e., manufacturer or designer to identify where exceptions
in pure steam distribution systems). exist or where the L/D of 2 or less cannot be met.
(h) The centerline radius of factory bent tubes shall An L/D of 2 or less may not be achievable for weir-
be in accordance with Table DT-3-1, CLR(R). type valves clamped to tees and certain sizes of close
(i) Piping systems described in Part SD refer to welded point-of-use valves, as shown in
hygienic tubing systems. Caution should be exercised Fig. SD-3.1.2.2-1, illustrations (a), (d), (e), (f), and (g).
if using pipe (instead of tube) to ensure that the require- For the header and valve size combinations where the
ments of this Standard are met. The requirements of L/D of 2 cannot be met using these configurations, a
hygienic tubing (e.g., surface finish, dimensions, and specific isolation valve design, as shown in
tolerances) are not typically met by pipe. Fig. SD-3.1.2.2-1, illustrations (b) and (c), may be
required to achieve the desired ratio.
SD-3.1.2 System Design
SD-3.1.2.3 System Piping (14)
SD-3.1.2.1 General (a) Routing of piping should be as direct and short
(a) Product hold-up volume in the system should be as possible to ensure a minimal quantity of CIP solution
minimized. to fill a circuit, and eliminate excessive piping and
(b) Bioprocessing piping and tubing design should fittings.
have routing and location priority over process and (b) Cross contamination of product streams shall be
mechanical support systems. physically prevented. Methods of separation used in
(c) Piping and connections to in-line valves should industry are
be of all-welded construction where feasible, practical, (1) removable spool piece
and agreed to by the owner/user and manufacturer. To (2) U-bend transfer panel
ensure the highest degree of hygienic design, the piping (3) double block-and-bleed valve system (see
systems should utilize welded connections except where Fig. SD-3.1.2.3-1)
make-break connections are necessary. (4) mix-proof valving
SD-3.1.2.2 Dead Legs. Dead legs will be measured (c) The use of fluid bypass piping (around traps, con-
by the term L/D, where L is the leg extension from the trol valves, etc.) is not recommended.
I.D. wall normal to the flow pattern or direction, and D (d) The use of redundant in-line equipment is not
is the I.D. of the extension or leg of a tubing fitting or recommended due to the potential creation of dead legs.
the nominal dimension of a valve or instrument. For (e) Eccentric reducers shall be used in horizontal pip-
valves, L shall be measured to the seal point of the valve. ing to eliminate pockets in the system.
Tables SD-3.1.2.2-1 and SD-3.1.2.2-2 indicate L/D values (f) The system shall be designed to eliminate air pock-
based on the BPE definition for various tubing geome- ets, and prevent or minimize air entrainment.
tries and configurations. (g) The centerline radius of field bent tubes should
There is evidence that an L/D of 2 or less may prevent be not less than 2.5 times the nominal tube diameter to
the branch from being a dead leg; however, the size and prevent the deterioration of interior surfaces (wrinkling,
shape of the branch are also important in determining striations, and potential cracking). Tighter bends may
if the branch could lead to contamination. With sufficient be used with the approval of the owner/user when
flow through a primary pipeline, a branch may not con- appropriate inspection techniques and procedures
stitute a dead leg. (visual, borescope, sectioning, etc.) are used.

20

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.1.1-1 Flat Gasket Applications (14)

(a) Flange With Flat Gasket (b) Flange With O-Ring

(c) Stub-End / Lap Joint (d) Weld Neck (e) Slip On

(f) Socket Weld (g) Threaded

21

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table SD-3.1.2.2-1 L/D Dimensions for Flow-


Through Tee: Full-Size Standard Straight Tee With
Blind Cap

Nominal Wall I.D. L/D


Size, in. Thickness (D) Branch, L (Branch)
1
4 0.035 0.180 2.16 12.00
3
8 0.035 0.305 2.10 6.88
1
2 0.065 0.370 2.07 5.58
3
4 0.065 0.620 2.07 3.33

1 0.065 0.870 2.19 2.52


112 0.065 1.370 2.14 1.56
2 0.065 1.870 2.44 1.30
212 0.065 2.370 2.44 1.03

3 0.065 2.870 2.44 0.85


4 0.083 3.834 2.83 0.74
6 0.109 5.782 4.24 0.73

22

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table SD-3.1.2.2-2 L/D Dimensions for Flow-Through Tee:


Short Outlet Reducing Tee With Blind Cap

Nominal Nominal Tee Wall Branch Wall Branch I.D., L/D


Size Tee, in. Branch Size, in. Thickness Thickness D Branch, L (Branch)
3 1
8 4 0.035 0.035 0.180 0.85 4.71
1 1
2 4 0.065 0.035 0.180 0.82 4.53
1 3
2 8 0.065 0.035 0.305 0.82 2.67
3 1
4 4 0.065 0.035 0.180 0.69 3.83
3 3
4 8 0.065 0.035 0.305 0.69 2.26
3 1
4 2 0.065 0.065 0.370 0.69 1.86

1
1 4 0.065 0.035 0.180 0.69 3.83
3
1 8 0.065 0.035 0.305 0.69 2.26
1
1 2 0.065 0.065 0.370 0.69 1.86
3
1 4 0.065 0.065 0.620 0.69 1.11
112 1
4 0.065 0.035 0.180 0.69 3.83
112 3
8 0.065 0.035 0.305 0.69 2.26

112 1
2 0.065 0.065 0.370 0.69 1.88
112 3
4 0.065 0.065 0.620 0.69 1.11
112 1 0.065 0.065 0.870 0.69 0.79
1
2 4 0.065 0.035 0.180 0.69 3.83
3
2 8 0.065 0.035 0.305 0.69 2.26
1
2 2 0.065 0.065 0.370 0.69 1.86

3
2 4 0.065 0.065 0.620 0.69 1.11
2 1 0.065 0.065 0.870 0.69 0.79
2 112 0.065 0.065 1.370 0.69 0.50
212 1
4 0.065 0.035 0.180 0.69 3.83
212 3
8 0.065 0.035 0.305 0.69 2.26
212 1
2 0.065 0.065 0.370 0.69 1.86

212 3
4 0.065 0.065 0.620 0.69 1.11
212 1 0.065 0.065 0.870 0.69 0.79
212 112 0.065 0.065 1.370 0.69 0.50
212 2 0.065 0.065 1.870 0.69 0.37
1
3 4 0.065 0.035 0.180 0.69 3.83
3
3 8 0.065 0.035 0.305 0.69 2.26

1
3 2 0.065 0.065 0.370 0.69 1.86
3
3 4 0.065 0.065 0.620 0.69 1.11
3 1 0.065 0.065 0.870 0.69 0.79

23

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table SD-3.1.2.2-2 L/D Dimensions for Flow-Through Tee:


Short Outlet Reducing Tee With Blind Cap (Contd)
Nominal Nominal Tee Wall Branch Wall Branch I.D., L/D
Size Tee, in. Branch Size, in. Thickness Thickness D Branch, L (Branch)

3 112 0.065 0.065 1.370 0.69 0.50


3 2 0.065 0.065 1.870 0.69 0.37
3 212 0.065 0.065 2.370 0.69 0.29

1
4 4 0.083 0.035 0.180 0.71 3.93
3
4 8 0.083 0.035 0.305 0.71 2.32
1
4 2 0.083 0.065 0.370 0.71 1.91
3
4 4 0.083 0.065 0.620 0.71 1.14
4 1 0.083 0.065 0.870 0.71 0.81
4 112 0.083 0.065 1.370 0.71 0.52

4 2 0.083 0.065 1.870 0.71 0.38


4 212 0.083 0.065 2.370 0.71 0.30
4 3 0.083 0.065 2.870 0.71 0.25
1
6 4 0.109 0.035 0.180 0.86 4.77
3
6 8 0.109 0.035 0.305 0.86 2.82
1
6 2 0.109 0.065 0.370 0.86 2.32

3
6 4 0.109 0.065 0.620 0.86 1.39
6 1 0.109 0.065 0.870 0.86 0.99
6 112 0.109 0.065 1.370 0.86 0.63
6 2 0.109 0.065 1.870 0.86 0.46
6 212 0.109 0.065 2.370 0.86 0.36
6 3 0.109 0.065 2.870 0.86 0.30
6 4 0.109 0.083 3.834 0.86 0.22

24

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.1.2.2-1 Accepted Point-of-Use Designs (14)

Note (1)
Note (2)

(a) (b)

Typical short-outlet tee

Minimal span
(room for
clamp only)
Note (1)
Note (2)
Note (1)
Branch
(full or
reduced size)
(c)

(d)

(e)

Branch may
be full or
reduced size
Short outlet
Note (1) to minimize
branch
length
Tangential side outlet
(to provide full drainage)

Note (1)

(f) (g)

NOTES:
(1) L/D of 2 or less.
(2) L/D p 0 (preferred).

25

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly

Process 1 Process 2

Bleed valve

(h) Ball valves are not recommended in fluid hygienic exposed threads, and have minimal potential for collect-
piping systems. See SD-4.2.3(b) for further comments. ing and trapping debris or liquids on the hanger. Materi-
(i) Process contact surfaces of austenitic stainless als of construction shall be corrosion resistant and
steel, except those covered by section SD-4.3.1, should compatible with the chemical, thermal, and physical
be passivated before being placed in service. Specific performance requirements of the installed location. The
passivation requirements shall be defined in the engi- materials shall have adequate strength and durability
neering design documents, and/or specifications and to withstand the application of continuous and/or cyclic
shall be in accordance with SF-2.6. Passivation of electro- thermal exposure that may be encountered in the
polished surfaces is not required unless the surface has designed service.
been altered (e.g., welded or mechanically polished) (b) The piping should maintain proper continuous
or exposed to external contamination after slope for drainability. Hygienic support systems shall
electropolishing. assist in maintaining the required slope and alignment
(j) The use of blind welds in piping systems should under all operating conditions taking into account ther-
be avoided. Proper installation sequencing of the piping mal cycling, distortion, settling, moment loads, fluid
system can reduce the number of blind welds. See specific gravity, etc. The support system should be
MJ-7.3.3(b) and GR-5.3.4 for further details. designed to distribute loads and stresses from any
potential movement. The supports shall be installed
SD-3.1.2.4 Hygienic Support Systems without adding stress to the tube or pipe in an attempt
(a) Hygienic supports should be used within classi- to achieve a desired slope.
fied spaces. Hygienic support design should incorporate (c) The support systems shall provide for, and control,
drainable geometry to facilitate cleanability, have no the intended movement of the system. The designer

26

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

should take into account system and equipment move- Fig. SD-3.2.1-1, illustrations (a) and (b)]. In temporary
ment when planning the design. Anchoring systems runs, hose assemblies may be manually drained after
should be designed to avoid piping motion in any of disconnecting.
the three Cartesian axes. Guiding systems should be (b) Hose assemblies shall be installed to avoid strain
designed to allow piping axial motion due to thermal on end connections. Hose assemblies shall not be used
or mechanical loads. An anchor serves to secure the as a substitute for rigid tube fittings or as tension or
piping in place, and a guide will allow axial motion of compression elements.
the piping and is used to allow for thermal expansion. (c) Hose assembly length should be minimized and
(d) Supports/hangers should be installed close to fitted for purpose.
each change in the direction of piping. The only excep- (d) Hose assemblies shall be easy to remove for exami-
tion is on short subassemblies using small diameter tube nation and/or cleaning.
(<1.000 in. O.D.) that is installed in a drainable position (e) Hose assembly shall be clearly marked or tagged
and does not bear any additional weights or loads from with the design allowable working pressure/vacuum
other process equipment. Hangers shall be of adequate and design temperature range.
strength and durability to withstand the imposed loads (f) Hose assemblies shall be inspected and main-
per MSS SP-58, Table 1. Per manufacturers recommen- tained on a scheduled basis.
dations, supports/hangers should be installed as close
to (and on both sides, if possible) concentrated loads SD-3.2.2 Flexible Element (14)
including valves, instrumentation, and filter housings. (a) The flexible element of the hose assembly shall
SD-3.1.2.4.1 Pipe Hangers and Supports for be constructed of materials that permit the appropriate
Metallic Piping. Metallic piping system hangers and degree of movement or drainable offset at installation.
supports shall be installed in compliance with MSS (b) The interior surface of the flexible element shall
SP-58, MSS SP-69, MSS SP-89, and ASME B31.3 Stan- be cleanable and drainable.
dards. The metallic pipe or tube to be installed shall meet (c) The materials used shall comply with the applica-
the straightness criteria of ASTM A1016 to optimize ble requirements in Part PM and/or Part SG with regard
drainability. The support spacing shall not exceed a dis- to biocompatibility. The materials used must also be
tance that will permit the piping to deflect under compatible with cleaning and/or SIP conditions.
operating conditions. SD-3.2.3 End Connections
SD-3.1.2.4.2 Pipe Hangers and Supports for (a) End connections shall be of a material and design
Nonmetallic Piping sufficiently rigid to withstand the combined forces of
(a) Nonmetallic piping system hangers and supports the burst pressure rating of the flexible element, the
shall be engineered based upon the specific materials compression forces required to affect the secure assem-
selected. When properly installed, stress concentration bly with the flexible element. [Refer to Fig. SD-3.2.1-1,
points will be minimized. Considerations shall be made illustrations (c) and (d).]
to ensure drainability and overcome any deflection, such (b) End connections shall be of a material compatible
that pooling is minimized. Refer to manufacturers rec- with the process fluid, cleaning solutions, and steam
ommendations for spacing, which are based upon calcu- where applicable. Materials shall meet the requirements
lations that take into consideration the piping material, of SD-2.4.1 or Part PM.
density, modulus of elasticity, diameter and wall thick-
(c) End connections shall meet all surface finish
ness of the pipe, specific gravity of the fluids being
requirements of Part SF or Part PM.
transported, operating temperature, and thermal expan-
(d) End connections shall be a hygienic connection
sion properties.
design per SG-3.3.2.
(b) The requirement of a continuous support shall be
determined based upon the operating temperatures and
SD-3.3 Pumps
the specific gravity of the process fluid being trans-
ported. Support channels may be available in a V or SD-3.3.1 Diaphragm Pumps. [Reserved for future
U section and shall be manufactured with no sharp content]
edges that may embed or cause damage to the pipe
exterior. These are commonly available in stainless steel SD-3.3.2 Hygienic Pumps
or FRP (fiberglass reinforced plastic) materials. These SD-3.3.2.1 General (14)
supports cannot restrict axial movement of the piping (a) Pumps shall be cleanable. Pumps shall be selected
and shall be approved by owner/user. according to the operating conditions determined by
SD-3.2 Hose Assemblies the end-owner/user (e.g., process, CIP, SIP, passivation).
(14) SD-3.2.1 General (b) All process contact connections to the pump shall
(a) Permanently installed hose assemblies shall be be of a hygienic design (see Figs. SG-2.2.2-1, SG-2.2.2-2,
installed and supported to be self-draining [see SG-2.2.2-3 and SG-2.2.2-4).

27

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-3.2.1-1 Flexible Hygienic Hose Design

Low point
Equipment Equipment
Drainable Flex hose in horizontal

(a) Accepted (b) Not Accepted

Securing collar or ring Band type clamp


Flexible element Flexible element
Gap

Substantially Gap
flush Process Process
Region Region

Hygienic fitting
Hygienic fitting with hose barbs
Uniform sealing force with hose barbs Nonuniform sealing force
(c) Accepted (d) Not Accepted

SD-3.3.2.2 Centrifugal Pumps SD-3.3.2.3 Positive Displacement Pumps


(a) Hygienic centrifugal pumps shall be capable of (a) When possible, positive displacement pumps
CIP. should be configured with vertically mounted inlets and
(b) All process contact surfaces shall be drainable outlets to promote drainability and venting.
without pump disassembly or removal. (b) When using internal bypass pressure relief
(c) Shrouded/closed impellers should not be used. devices, they shall be of a hygienic design. It is preferred
Fig. SD-3.3.2.2-1 illustrates open, semi-open, and closed that an external, piping mounted relief device (hygienic
impeller configurations. rupture disc) rather than a pump mounted bypass be
(d) Impeller shall be attached to shaft in a way that used.
all crevices and threads are not exposed to product. SD-3.3.2.4 Rotary Lobe Pumps (14)
Threads, such as in an impeller nut/bolt, shall be sealed (a) The owner/user shall specify the chemical, ther-
by an O-ring or hygienic gasket. Refer to mal, and hydraulic operating conditions of the pump
Fig. SD-3.3.2.2-2. The use of O-rings or hygienic gaskets (e.g,. process, CIP, SIP) to ensure proper component
shall be consistent with Part SG. selection. Hygienic rotary lobe pumps are temperature
(e) Suction, discharge, and casing drain connections sensitive (e.g., rotor to casing contact due to thermal
shall be an integral part of the pump casing. expansion).
(f) Casing drains shall be at the lowest point of the (b) The pump should be designed and installed to
casing, to ensure drainage (see Fig. SD-3.3.2.2-3). minimize hold-up volume.
(g) The use of an elbow type casing drain is not recom- (c) Rotor fasteners shall be attached to the shaft in a
mended without the use of an automatically controlled way that crevices and threads are not exposed to prod-
drain. The casing drain connection shall be designed to uct. Threads and crevices shall be isolated from the prod-
minimize the L/D as shown in Fig. SD-3.3.2.2-4. uct by an appropriate hygienic seal, such as an O-ring
(h) Pump discharge connection should be tilted to or hygienic gasket (see Fig. SD-3.3.2.4-1).
allow for full venting of the casing (see Fig. SD-3.3.2.2-3). (d) Pump cover shall seal against the pump body by
(i) All pump seals should be designed to minimize means of an O-ring or hygienic gasket.
seal material degradation. (e) All process contact O-rings, gaskets, and shaft
(j) Shaft seals shall conform to Part SG. seals shall comply with Part SG.

28

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.3.2.2-1 Pump Impeller Configurations

(a) Open (b) Semi-Open (c) Shrouded/Closed

Fig. SD-3.3.2.2-2 Acceptable Impeller Attachments (14)

Sealing region
Sealing region

Sealing region

(a) Impeller Nut With O-Ring (b) Impeller Nut With Hygienic Gasket (c) No Impeller Nut

29

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.3.2.2-3 Casing Drain Configurations

(a) Horizontal (b) Vertical

(14) Fig. SD-3.3.2.2-4 Casing Drain L/D Ratios

D D
D

L
L L

(a) Weir-Style (b) Radial-Style (c) Capped


Diaphragm Valve Diaphragm Valve

30

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-3.3.2.4-1 Rotary Lobe Pump Rotor (h) Test protocols for drainability shall be agreed upon
Attachment in advance, by all the parties (see SD-6.4). All vessels
should be checked for drainability during fabrication.
Rotor
SD-3.4.2 Vessel Openings
Pump cover
(a) Nozzles that are designed to be cleaned by a spray
device should have the smallest L/D ratio possible. For
Rotor fastener non-flow through nozzles, the L/D of 2 or less is recom-
Shaft mended (see Fig. SD-3.4.2-1).
(b) Bottom-mounted agitators, pads, etc., shall not
interfere with the drainability of the vessel.
(c) All instrument probes and any sidewall penetra-
tions (see Fig. SD-3.4.2-2) shall be sloped for drainage,
unless the instruments used require horizontal mount-
ing (see Fig. SD-3.4.2-3).
(d) Blank covers shall have the same finish as the
vessel internals.
O-ring (e) Drain valves should optimize drainability and
minimize branch L/D.
(f) The location and number of spray devices should
be chosen to eliminate shadowing at internal parts such
(f) If a pressure relief device is used, it shall be of as mixer shafts, dip tubes, and baffles.
hygienic design in conformance with SD-3.15. (g) Sparger and dip tubes shall be designed in accor-
dance with SD-3.4.1(a), (b), (e), (g), and (h). Sparger
SD-3.4 Vessels and dip tubes shall incorporate low point drains (where
applicable, i.e., horizontal lines) and be supported to
(14) SD-3.4.1 General ensure drainability.
(a) SD-3.4.1 defines the requirements that are to be (h) The number of shell side nozzles and connections
met in the design, fabrication, and supply of biopharma- should be minimized.
ceutical vessels, tanks, bioreactors, fermentors, and col- (i) Manways on the side shell of a vessel shall be
umns. This section will refer to all of the above as vessels installed only by agreement of the owner/user. If side-
whether they are pressurized or not. shell manways are required, they shall be sloped for
(b) Design and fabrication of vessels and internal drainage.
parts shall ensure that surfaces are free of ledges, crev- (j) Sample valves should be designed for CIP and SIP
ices, pockets, and other surface irregularities. If more where applicable. Sample valves located on vessels shall
restrictive tolerances are required, they shall be included be of a hygienic design.
as part of the fabrication specifications for the project. (k) Sample valves should not be located on bottom
(c) All heat transfer surfaces should be drainable and heads.
ventable. (l) Dip tubes and spargers mounted in the nozzle neck
(d) Breastplates, reinforcing pads, doubler plates, poi- should have an annular space between the O.D. of the
son pads, etc., which are required for welding dissimilar dip tube or sparger and the I.D. of the nozzle neck in
material to the vessel, should be of the same material accordance with Table SD-3.4.2-1. An L/A of 2 or less is
as the vessel. No telltale holes are allowed on process recommended (see Fig. SD-3.4.2-4). If a larger L/A exists,
contact surfaces and those, which are outside, should a method for cleaning this space shall be specified. In
be cleanable. all cases sufficient annular space to allow access for CIP
(e) Vessels that are to handle above 176F (80C) coverage shall be provided.
[e.g., SIP, hot water-for-injection (WFI), hot (m) As required by the process, inlet nozzles tangen-
U.S. Pharmacopeia (USP) waters, and hot CIP solutions] tial to the vessel surface may be used (see Fig. SD-3.4.2-5
should be designed for full vacuum service. and Fig. PI-9.1.3.3-1).
(f) Top and bottom heads on vessels that are cleaned (n) Nozzle connections less than 1 in. (25 mm) in
in place shall be self-draining. Dished heads such as diameter are not recommended unless agreed to by the
ASME flanged and dished (F&D), elliptical, and hemi- owner/user and manufacturer.
spherical are the usual choice; however, flat and conical (o) Sight glasses on the vessels should be designed
heads should slope at not less than 18 in./ft (10 mm/m) with reference to SD-3.4.2(a). Sight glasses on vessels
to a common drain. should be designed with the smallest L/D possible, and
(g) All internal surfaces should be sloped or pitched incorporate cleanable O-ring designs when applicable
for drainability. (see Fig. SD-3.4.2-6).

31

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-3.4.2-1 Nozzle Design

Minimum 1 in. between fittings Minimize


Minimize

Vertical Nozzles Radial Nozzles

(a)
Allow for Clamp Access
[Notes (1) and (2)]

Same distance

(b)
[Notes (3) and (4)]

(c) [Note (5)]


NOTES:
(1) Less dead space.
(2) Better CIP/SIP capabilities.
(3) Potential problems with CIP and SIP with capped connections.
(4) Dead space: stagnant areas.
(5) All L/D ratios to be calculated on long-side dimensions for vessel heads.

32

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.4.2-2 Side and Bottom Connections (14)

Dished head or shell

Radius

Note (1)
(a) Accepted

Nondraining edge

Note (2)

(b) Accepted (c) Not Accepted


NOTES:
(1) If a flat gasket is used, mismatch of diameters can result in crevices.
(2) Telltale hole required.

Fig. SD-3.4.2-3 Sidewall Instrument Ports (14)

0 or 15
5

Minimize
landing

Minimize

(a) Accepted (b) Accepted (c) Accepted


[Note (1)]

NOTE:
(1) May also be pitched similar to illustration (b).

33

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table SD-3.4.2-1 Annular Spacing


Recommendations for Hygienic Dip Tubes
Dip Tube Size Mount Nominal
Tube O.D. Size
in. mm in. mm
1
2 12.7 2 50
3
4 19.1 2 50
1 25.4 3 75
112 38.1 3 75
2 50.8 4 100
212 63.5 4 100
3 76.2 6 150
4 101.6 6 150

(14) Fig. SD-3.4.2-4 Accepted Nozzle Penetrations


Mechanical seal area

A L

A
(a) Dip Tube or Sparge
[Notes (1) (3)]

(b) Agitators
[Notes (2) and (4)]
NOTES:
(1) Nozzle and dip tube size per Table SD-3.4.2-1.
(2) L/A less than 2:1.
(3) Requirements also apply to nozzles with instrument penetrations.
(4) A p 1 in. (25 mm) minimum.

34

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.4.2-5 Vessel Design Tangential Nozzles (14)

Definition of L/D for Tangential Inlet:


Top Section View

GENERAL NOTE: CIP through nozzle is recommended.

35

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.4.2-6 Sight Glass Design


(Accepted)

(a) Full Flange Sight Glass (b) Hygienic Clamp on Hygienic Pad Connection
on Hygienic Pad Connection

(c) Hygienic Clamp Sight Glass (d) Hygienic Cross Sight Flow Indicator

(e) Typical Vessel Sight Glass Mounting Tangent to Tank Head

36

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.4.2-7 Typical Nozzle Detail (14)

Outside groove design

Inside groove design

Radius

(a) Swage/Butt Weld Design (b) Full Penetration Groove Weld


(Accepted: If Vessel Wall Is With Fillet Design
Thin Enough to Flare) (Accepted)

(p) Manway covers should be dished rather than a (c) Where it is inevitable and Class 150 slip-on flanges
flat design. are used, the bore side bevel weld shall be designed in
(q) Flanges that have metal-to-metal contact on the a way to eliminate potential CIP difficulties.
product side shall not be used. See Fig. SD-3.4.2-3 for (d) During handling and transportation, vessels and
possible designs that minimize the crevice on the inter- their parts and piping assemblies shall be suitably pro-
nal sidewall of the vessel. tected to prevent damage to polished surfaces.
(r) All side-shell and vessel head nozzles should be
SD-3.4.5 Finishes (14)
flush with the interior of the vessel (see Fig. SD-3.4.2-7).
(a) Surface finishes shall be specified and measured
Additional ports may require a minimum projection to
as required by Part SF. Surface finish coupons shall be
ensure additives are directed into the vessel fluid.
submitted when agreed to by the owner/user and
SD-3.4.3 Internal Components manufacturer.
(a) When expansion joints are used internally, the sur- (b) Process contact surface finish specifications shall
face in contact with the process fluids shall have open pertain to all the wetted or potentially wetted surfaces
convolutes without guides as the preferred design. (e.g., vapor space, nozzle necks, agitators, thermowells,
(b) Internal support members shall be solid, rather dip tubes, baffles, etc.).
than hollow, which have a higher risk of fatigue and (c) The polishing of a connection face, body flange,
contamination problems (see Fig. SD-3.4.3-1). etc., shall extend up to the first seal point.
(c) Mitered fittings for internal pipe work shall only
SD-3.4.6 Sight Glasses
be fitted with the prior agreement between the owner/
(a) When glass is used as the sight glass material,
user and manufacturer. When mitered joints are used,
the preferred method is glass fused-to-metal hermetic
they shall be designed and fabricated in accordance with
compression seal. The fused glass shall be circular in
the appropriate codes.
shape within the metal frame.
(d) Vessels shall drain to a common point and shall
(b) Bubbles in the fused sight glass are acceptable,
not have multiple draining points, unless agreed to
but the size and quantity should be kept to a minimum.
between the owner/user and manufacturer.
Any bubbles at the glass surface are not acceptable.
(e) The number of components inside the vessel
(c) The seal point of the glass fused-to-metal sight
should be minimized to ensure the proper drainability
glass is at the surface. The surface of the sight glass
and cleanability of the vessel, and when used, if possible,
shall be integral, continuous, and free of cracks, crevices,
should be supported by a solid support structure.
and pits.
SD-3.4.4 Fabrication (d) Cracked glass shall not be used and is cause for
(a) Butt welds should be used, if possible, minimizing rejection and removal.
lap joint welds and eliminating stitch welding. (e) Surface finish for the metal frame shall meet the
(b) Flanges are not recommended, and their use shall requirements of Part SF in this Standard.
be minimized. The bore of weld neck flanges shall be (f) Sight glasses shall be marked with the glass type,
the same as the I.D. of the connected pipe or tubing to maximum pressure, and temperature rating per DT-11.1
prevent ledges and nondrainable areas. and DT-11.1.1.

37

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-3.4.3-1 Internal Support Members

Round
bar stock

(a) Hygienic Design (b) Nonhygienic Design


(Accepted: Sloped, Minimum Shadow, (Not Accepted: Flat Surfaces,
and Curved Surface) Ledges, and CIP Shadows)

Stitch weld:
Continuous weld not drainable
crevice
Drainable

Welded pad or
doubler plate Doubler plate

Capable of CIP Not capable of


(no shadows) CIP (shadow)

(c) Good Design (d) Poor Design


(Accepted) (Not Accepted)

Pooling
potential
CIP
Thermowell Thermowell
CIP

Droplet formation
Cascading
>5 action

(e) Positive Slope in All Directions (f) Positive Slope in Only One Direction
(Accepted) (Accepted)

38

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(g) Part SG requirements shall be met when mounting etc.) should be avoided to minimize potential cleanabil-
a sight glass. ity issues.
(h) Preferred sight glass mountings are shown in
Fig. SD-3.4.2-6. SD-3.5.2 In-Tank Shaft Couplings
(a) Welded in-tank shaft connections are preferred.
SD-3.4.7 Portable Tanks. [Reserved for future
content] (b) The use of in-tank shaft couplings shall be agreed
to by the owner/user.
SD-3.4.8 Media Bulk Containers. [Reserved for (c) In-tank couplings shall be of an accepted hygienic
future content] design. See examples in Fig. SD-3.5.2-1.
SD-3.4.9 Cryogenic Containers. [Reserved for future (d) In-tank coupling location should be driven by pro-
content] cess and mechanical considerations.
(e) Threaded shaft connections are accepted for in-
SD-3.5 Agitators and Mixers
tank couplings [see Fig. SD-3.5.2-1, illustration (a)].
(14) SD-3.5.1 General (1) Shaft rotation is limited to a single direction for
(a) All process contact surfaces of agitators and mix- threaded shaft connections to ensure that shaft sections
ers with their associated components shall be accessible do not separate.
to the cleaning fluids as specified by the end-user for (2) The designer will ensure that the use of a
clean in-place service (CIP; e.g., via spray, directed flow, threaded shaft connection is appropriate for the selected
immersion, etc.). shaft diameter and design loads.
(b) Process contact surfaces should be self-draining
(3) Hygienic bolted coupling construction may be
and shall not inhibit drainage of the vessel.
used where appropriate for the particular application
(c) Machined transitions (shaft steps, coupling sur-
[see Fig. SD-3.5.2-1, illustration (b)].
faces, wrench flats, etc.) should be smooth, with 15 deg
to 45 deg sloped surfaces. (f) Threads shall not be exposed in any type of shaft
or coupling hardware connection.
(d) The annular space between the agitator shaft and
the agitator nozzle shall, for cleaning purposes, have an (g) The preferred location for fastener hardware is
L/A of 2 or less, or a minimum of 1 in. (25 mm) gap, on the underside of couplings. Accepted fastener types
whichever is larger, to facilitate CIP spray coverage [see include
Fig. SD-3.4.2-4, illustration (b)]. (1) hex-head cap screws
(e) Cleaning and sterilization parameters shall be pro- (2) acorn-head cap screws
vided by the owner/user prior to design of the agitator. (3) threaded studs with acorn nuts
The manufacturers of agitators and mixers shall verify (h) Fastener heads shall be free of raised or engraved
the cleanability of their equipment as specified and markings that might inhibit cleanability.
agreed to with the end-user.
(i) O-rings rather than flat gaskets are preferred to
(f) Top-entering mixers with shaft seals are typically
seal coupling mating surfaces. Figure SD-3.5.2-2 presents
mounted to a vessel using a flanged or hygienic clamp
the following acceptable approaches for seal
connection [see Fig. SD-3.5.1-1, illustrations (a), (b), and
applications:
(c)]. The designer shall ensure that
(1) the use of O-rings or hygienic gaskets to seal (1) O-ring located in a single groove inboard of the
between mating surfaces shall be consistent with the coupling outside diameter [see Fig. SD-3.5.2-2, illustra-
current guidance provided in Part SG (see tion (a)]; O-ring compression, internal space to accom-
Fig. SG-3.3.2-1). modate compression, and outboard clearance space all
(2) the selected mounting arrangement will sup- designed to minimize the intrusion of process fluid
port the agitator mounting design loads while achieving between the coupling faces and to facilitate flow of
an appropriate seal. CIP fluid.
(3) the flange and nozzle construction is consistent (2) Alternate construction for O-ring located in a
with requirements of other applicable codes and stan- groove just inboard of the coupling outside diameter
dards [e.g., ASME BPVC, Section VIII; ASME B31.3, etc.] [see Fig. SD-3.5.2-2, illustration (b)]; O-ring restrained
(g) Socket head cap screws shall not be used in contact by lip at coupling circumference with clearance space
with the product. provided as above to insure cleanability of the cou-
(h) The design of agitator process contact parts should pling area.
minimize the occurrence of void spaces. All voids should (3) Alternate construction for O-ring located in
be closed by either fabrication (welding) or approved grooves in both coupling halves inboard of the coupling
sealing techniques (O-ring seals, etc.). outside diameter [see Fig. SD-3.5.2-2, illustration (c)];
(i) The use of in-tank non-welded connections (shaft outboard clearance space provided as above to ensure
couplings, impeller hub-to-shaft, impeller blade-to-hub, cleanability of the coupling area.

39

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-3.5.1-1 Agitator Mounting Flanges

(a) Bolted Flange With O-Ring (b) Hygienic Union With Gasket

(c) Pad Flange

(4) O-ring with attached inboard flat segment (g) Permanent shaft hardware that may be required
located between coupling faces [see Fig. SD-3.5.2-2, illus- for routine maintenance (e.g., support collars for
tration (d)]; outboard clearance space provided as above mechanical seal installation and removal, lifting eyes
to ensure cleanability of the coupling area. for shaft and/or impeller installation and removal, etc.)
(j) Bolted flanges shall be sealed. Examples of shall be fully drainable and cleanable as noted for other
accepted fastener seals are shown in Fig. SD-3.5.2-3 as features in contact with the product.
follows: SD-3.5.4 Hubs and Impellers
(1) O-ring seal [illustration (a)] (a) All-welded impeller assemblies (e.g., hubs, blades)
(2) O-ring seal alternate [illustration (b)] are preferred.
(3) seal washer with metal core [illustration (c)] (b) Impeller hubs welded to the shaft are preferred
over removable hubs.
SD-3.5.3 Shafts and Keyways
(c) Removable, hygienic impellers may be used where
(a) One-piece shaft construction, without mechanical impeller adjustment or substitution is required for pro-
couplings, is preferred. cess reasons or where impeller removal is required due
(b) Solid shafts are preferred over hollow shafts. to mechanical design and/or installation considerations.
(c) Hollow shafts, if used, shall be of sealed (welded) (1) Removable impellers may be one-piece or split
construction, inspected for integrity, and accepted per hygienic construction.
criteria given in Part MJ prior to installation. (2) Hub-to-shaft clearance for removable impellers
(d) Keyways exposed to product are not shall be sufficient to preclude shaft surface finish dam-
recommended. age during installation and removal.
(e) Keyways, where employed due to mechanical (3) Removable hardware (e.g., impeller hub and
design considerations, shall have edge radii as specified shaft, impeller set-screws and hub, etc.) should be sealed
by SD-2.4.2(g). in a manner consistent with the guidance provided for
(f) Keyways may require additional design and/or in-tank couplings (see SD-3.5.2).
cleaning practice to ensure drainage and cleanability (d) Removable impellers and impellers with flat, hori-
[e.g., spray ball and/or wand additions, increased CIP zontal surfaces (e.g., flat-blade disc turbines, concave-
flow, and adjusted spray coverage]. blade disc turbines, etc.) may require additional design

40

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.5.2-1 Shaft Coupling Construction (14)

15 to 45

15 to 45

Wrench flats

Note (1)

(a) Threaded Coupling (b) Bolted Coupling


(Accepted) (Accepted)

NOTE:
(1) See Fig. SD-3.5.2-3 for alternative bolt seals.

41

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-3.5.2-2 Shaft Coupling Seal Arrangements

(a)

(b)
O-ring groove detail

(c)

(d)

Threaded Coupling Example


Detail, Accepted Alternates

42

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.5.2-3 Fastener Seal Arrangements (14)

(a) Accepted (b) Accepted (c) Accepted

Alternate Bolting Designs

and/or cleaning practice to ensure drainage and clean- drain holes, spray ball and/or wand additions, increased
ability, e.g., drain holes, spray ball and/or wand addi- CIP flow, operating the agitator with the magnetically
tions, increased CIP flow, adjusted spray coverage, driven impeller immersed in CIP fluid).
impeller rotation. (g) The arrangement of wear surfaces (bushing, shaft,
or shaft sleeve) shall facilitate drainage.
SD-3.5.5 Impeller and Shaft Support Bearings
(a) Normal operation of a shaft-steady bearing or a SD-3.5.6 Mechanical Seals
magnetically driven mixer with in-tank impeller or shaft (a) Mechanical shaft seals shall incorporate design
support bearings (see Figs. SD-3.5.5-1 and SD-3.5.5-2) features for drainability, surface finish, material of con-
generate particulate debris. It is the responsibility of struction, etc., as outlined in Part SD, and shall be suit-
the end-user to establish compliance with applicable able for the application (e.g., Process, CIP, SIP,
standards (e.g., USP limits for particulate material in Passivation).
injectables) as appropriate. (b) Normal operation of a mechanical seal generates
(b) Tank plates that support bottom-mounted mag- particulate debris. It is the responsibility of the end-user
netically driven mixers shall not interfere with drainage to establish compliance with applicable standards (e.g.,
of the vessel. USP limits for particulate material in injectables) as
(c) When an application mandates the use of shaft appropriate.
steady/foot bearings, design features and/or proce- (c) Seal debris wells or traps (see Fig. SG-2.3.2.3-2)
dures are required to ensure cleanability (e.g., drain may be used to prevent ingress of seal face wear particles
holes, spray ball and/or wand additions, increased CIP that could contaminate the process fluid.
flow, operating the steady bearing immersed in CIP (d) Refer to Part SG of this Standard for specific seal
fluid). design details.
(d) Shaft-steady bearings, where used, shall not inter- SD-3.6 Heat Exchange Equipment
fere with the drainage of the vessel.
(e) Shaft-steady bearing pedestal support members Plate and frame type heat exchangers should be used
may be of solid or hollow construction. Hollow pedestal only by agreement between owner/user and designer
supports, if used, shall be of sealed (welded) construc- due to the difficulty of CIP and SIP.
tion, inspected for integrity, and accepted per criteria SD-3.6.1 General (14)
given in Part MJ after installation. (a) Straight tube heat exchangers are easier to clean
(f) Magnetically driven mixers require design fea- and inspect. The tubes can be seamless or full-finish
tures and/or procedures to ensure cleanability (e.g., welded, as specified by the owner/user or manufacturer.

43

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.5.5-1 Shaft Steady Bearing

44

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount) (14)

Impeller

Impeller (driven) magnet

Impeller hub
Magnetic coupling Bearing surface
comprised of these parts
Weld plate

Impeller blades

Drive magnet

Gear reducer
Motor Tank head

(b) The heat exchanger process and nonprocess con- Nominal Tube O.D. Minimum Bend Radius
tact surface inspection shall be possible by conventional in. mm in. mm
means.
(c) The technique used to form U-bend tubes shall 0.375 9.5 0.625 15.2
0.500 12.7 0.750 19.1
ensure the bending process does not create structural
0.625 15.8 0.938 23.8
imperfections (e.g., cracks, voids, delaminations). The 0.750 19.1 1.125 28.6
technique should minimize surface imperfections (e.g., 1.000 25.4 1.500 38.1
orange peel, rippling). If requested by the end-user, the
manufacturer shall supply a sectioned sample of the (g) Welded shell and tube heat exchangers shall be
bend area. of a double tubesheet design to prevent product contam-
(1) The sectioned sample should be from the same ination in the case of a tube joint failure (see
tube batch or heat that will be used to fabricate the heat Fig. SD-3.6.1-1).
exchanger. (1) During fabrication, when the tubes are to be
(2) The sectioned sample shall be the smallest bend expanded into the inner and outer tubesheets, the pro-
radius in the exchanger. cess contact surface shall not be scored.
(3) The sample shall be sectioned so that bends (2) Tubes shall be seal welded to the outer
centerline is visible. tubesheet.
(d) The internal surface of the U-bends shall be free (3) The distance between inner and outer tube-
of relevant liquid penetrant indications, as defined by sheets shall be sufficient to allow leak detection and
ASME BPVC, Section VIII. examination.
(e) The I.D. of the U-bends shall be large enough for (4) Tubesheets and channels shall be drainable.
a borescopic inspection. (h) The owner/user shall specify the orientation of
(f ) Minimum recommended bend radii for heat the exchanger (i.e., horizontal or vertical), and the manu-
exchangers should be as follows: facturer shall ensure the complete product drainability,

45

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design


Outer tubesheet
Inner tubesheet
Accepted Bonnet

Full radius on
bonnet pockets
Pass rib drain slot Shell assembly
Note (1)

Tube deformation from forming U-tube bundle


(typical on both tubesheets)

Inner tubesheet
Outer tubesheet Leak detection slots

Seal weld
Tube bundle must slope towards bonnet

U-tube bundle
Tube hole key cut groove
(typical on both tubesheets)
NOTE:
(1) Owner to specify inlet tubing slope. Heat exchanger manufacturer to slope inlet on bonnet to match inlet tubing slope.

46

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

other than the natural cohesive properties of the product, on the backside of panels will help reduce the number
at the specified orientation. If this hold-up is unaccept- of incorrect piping connections during field installation.
able, then the system needs to be designed with some
SD-3.7.2 Nozzles or Ports
type of assist to aid draining, such as an air blow down.
(a) Nozzle construction shall accommodate a design
(1) In the specified orientation, the shell side shall
feature that will assist in the elimination of internal
also be drainable (e.g., WFI condensers).
surface anomalies caused in part by joining the nozzle
(2) Transverse baffles with notches should be pro- to the panel structure.
vided, when necessary, to allow for proper draining of
(b) The method of joining a nozzle into a panel struc-
the shell.
ture shall be of hygienic design. Acceptance criteria for
(3) The heat exchanger bonnet shall be match these welds shall meet the requirements of
marked with the outer tubesheet for proper orientation Table MJ-8.5-1.
to ensure drainability or cleanability.
(c) Each front nozzle connection shall be of a hygienic
(i) Heat exchanger thermal and mechanical calcula- design and the horizontal projection minimized to opti-
tions shall be performed for both operating and SIP mize drainability.
cycles. (d) To ensure proper panel functionality and joint con-
(j) In shell and tube heat exchangers, the design pres- nection integrity, panel nozzles shall not be sloped (see
sure for the product side shall be no less than the design Fig. SD-3.7.2-1).
pressure of the utility side. (e) Nozzle-to-nozzle clearance shall be such that
(k) The type of connections to the utility side (shell jumper drain valve interference, if applicable, will not
side) shall be agreed to between the owner/user and occur when jumpers are connected in all possible
manufacturer. operating and cleaning configurations.
(14) SD-3.6.2 Cleaning and Steaming (f) Nozzles shall be capable of being capped. Caps
(a) The process contact surfaces shall be constructed may include bleed valves or pressure indicators for
to withstand CIP and SIP or other cleaning/bioburden safety or operating purposes.
control methods specified by the owner/user. (g) Nozzle center-to-center and flatness tolerances are
extremely critical to proper panel functionality and shall
(b) The cleaning and steaming conditions shall be pro-
be agreed upon by the manufacturer and end-user. Rec-
vided by the owner/user prior to the design of the heat
ommended tolerances are per Table DT-7-2 and
exchanger.
Fig. SD-3.7.2-1.
SD-3.6.3 Gaskets and Seals
SD-3.7.3 Headers or Pre-piped Manifolds
(a) Gaskets that are in contact with product shall be (a) When a looped header design is employed, the
removable and self-positioning, and shall have readily branch length at capped or unused nozzles should be
cleanable grooves. minimized. The dimension of the subheader leg to the
(b) Channel/bonnet gaskets shall be of a cleanable nozzle face should not exceed an L/D of 2 (see
design. Fig. SD-3.7.1-1). A dead-ended and/or unlooped sub-
header is not recommended.
SD-3.7 Transfer Panels
(b) To optimize the drainability at all nozzles, regard-
(14) SD-3.7.1 General less of use, subheaders and pre-piped manifolds shall
(a) The transfer panel shall be constructed so that the not be sloped. All-encompassing lines including long
process contact surfaces can be cleaned by a CIP fluid or runs with the exception of subheaders, manifolds, and
other method specified by the owner/user. The process nozzles may be sloped as defined in SD-2.4.3.
contact surfaces shall be free of crevices, pockets, and SD-3.7.4 Jumpers or U-Bends
other surface irregularities. (a) Jumpers shall be constructed with hygienic con-
(b) The transfer panel nozzle elevation shall be prop- nections on both ends designed to mate with the panel
erly designed with respect to the connecting equipment nozzles.
such as tank, pump, etc., to ensure drainability, clean- (b) Jumpers may have a low point drain to provide
ability, and bioburden control during process transfer, both complete drainage and vacuum break after the
CIP, and SIP. liquid transfer has been completed (see Fig. SD-3.7.4-1).
(c) Design and fabrication of the transfer panel and The branch L/D of a low-point drain connection should
associated components must ensure that the piping sys- be minimized. Zero static diaphragm valves are recom-
tem can be fully drained when properly installed. This mended for low-point drains if available from the manu-
is not to imply that panel nozzles and/or subheaders facturer [see Fig. SD-3.7.4-1, illustrations (a) and (d)].
should be sloped (see Fig. SD-3.7.1-1). Low-point drain designs that incorporate a spool piece
(d) Tagging/labeling of the transfer panel and its allow for full rotation of the drain valve [see
components shall be per SD-2.4.4.2(i). Tagging nozzles Fig. SD-3.7.4-1, illustrations (a), (b), and (c)]. This design

47

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.7.1-1 Transfer Panel Looped Headers


Minimize

Slope

Level

Slope Level
Level

(a) Accepted

(b) Not Accepted

48

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.7.2-1 Transfer Panel Tolerances (14)


(Reference Table DT-7-2)
Inspection
planes for
reference

Note (1)

Center Center
to to Note (2)
center center

Note (1)

NOTES:
(1) Flatness tolerance defines the maximum gap allowed across the entire sealing surface relative to the inspection planes shown above.
(2) Tolerances applied to related nozzles (defined by jumper paths).

49

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-3.7.4-1 Transfer Panel Jumpers

(a) Accepted

(b) Accepted (c) Accepted (d) Accepted

(e) Not Accepted (f) Not Accepted (g) Not Accepted

50

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

ensures that the drain valve is always at the true low magnetic material is required; however, it must be fully
point of the assembled jumper connection in any speci- encapsulated to ensure that the ferrous material does
fied orientation. not contaminate the classified manufacturing area. The
(c) Jumper center-to-center and flatness tolerances are acceptance criteria for welds joining the sensor stem to
extremely critical to proper panel functionality. Recom- the jumper shall meet the requirements of Table MJ-8.5-1.
mended tolerances are per Table DT-7-2 and (d) The magnet should be of sufficient gauss rating
Fig. SD-3.7.2-1. to properly activate the corresponding proximity switch.
(d) The use of reducing jumpers is not recommended In addition, the temperature rating of the magnet should
due to drainability concerns based on jumper orienta- withstand the specified temperature ranges for process
tion. Any reduction in line size should be made behind and SIP without compromising the magnet
the primary nozzle connection (behind panel structure), performance.
thus allowing all connections to be the same size on the (e) The proximity switch mounting shall be of
front of the panel. hygienic design and structurally sound to maintain the
(e) The overall panel design shall be such that the specified design location.
quantity of unique jumper centerline dimensions is
minimized. SD-3.8 Filters (14)
(f) The same jumper should be used for process trans-
fer, CIP, and SIP. SD-3.8.1 Code 7 Cartridge Lock Design. The ASME
(g) If a pressure indicator is installed on a jumper, it BPE Code 7 lock is designed to be used with filter car-
must be a hygienic design and mounted in a manner tridges using an SAE AS 568-226 double O-ring seal and
that maintains drainability in all jumper positions. The a two-locking-tab design.
L/D should be 2 or less.
SD-3.8.1.1 Design Features. This design consists
SD-3.7.5 Drain or Drip Pans of the following features:
(a) Drain pans, if utilized, shall be built as an integral (a) a socket bore that is machined into a base or car-
part of the transfer panel. The intended function is to tridge plate into which the filter cartridge O-ring adapter
collect spilled fluids that can occur during jumper or is inserted.
cap removal. (b) locking tab retainer mechanism that captures the
(b) Drain pans shall slope [preferred minimum of cartridge locking tabs when the cartridge is inserted into
1
4 in./ft (21 mm/m)] to a low point and be piped to the the socket bore.
process drain. The depth of the drain pan is determined (1) Fig. SD-3.8.1.1-1 shows a recessed tapered lock
by calculating the largest spill volume and accommodat- retainer design in which the locking tab retainers are
ing it with a sufficient pan holding volume. Consider- machined into a plate and the machined recesses capture
ation should be given to increasing the drain port the cartridge locking tabs as the cartridge is rotated into
connection size in lieu of increasing pan depth. The position.
preferred drain port location is central bottom draining
(2) Fig. SD-3.8.1.1-2 shows an external tapered lock
or central back draining.
retainer design in which a set of metal cages captures
(c) The elevation of the pan should take into account
the cartridge locking tabs as the cartridge is rotated into
the clearance required for the jumper drain valve posi-
position.
tion when a connection is made to the bottom row of
nozzles. The pan should extend horizontally to accom- (c) the locking tab retainers shall be designed with a
modate the furthest connection and/or drain point from taper to provide a secure lock for the cartridge. The
the face of the panel. cartridge tabs shall travel through the narrowing tab
retainers until a tight fit is achieved. The taper shall be
SD-3.7.6 Proximity Switches on the upper portion of the tab retainer. Full capture of
(a) Proximity switches are used to detect the presence cartridge tabs by the locking tab retainers is not required
or absence of a jumper with a stem positioned between to secure cartridges for operation.
selected nozzles. (d) all surfaces of the cartridge socket shall meet the
(b) The use of magnetic proximity switches, which required finish for the wetted surfaces as specified by
are mounted behind the panel structure avoiding the the owner/user.
need to penetrate the panel face, are preferred. This (e) the cartridge O-ring(s) shall be completely con-
elimination of structural penetration will remove any tained within the socket bore.
unnecessary cracks, crevices, or threads at the point of
attachment, thus removing the risk of product entrap- SD-3.8.1.2 Testing. The cartridge manufacturer
ment and/or contamination concerns. shall validate that its cartridge design fits, seals, and
(c) Jumpers will contain a magnetic stem to activate remains in place with one of the housing designs shown
the corresponding proximity switch. The use of a ferrous in Figs. SD-3.8.1.1-1 and SD-3.8.1.1-2.

51

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.8.1.1-1 Tapered Locking Tab Retainer Recessed

R1.43 0.010 in. (36.3 0.25 mm)


clearance for locking tabs

1.25/1.40 in. (31.8/35.6 mm)


clearance for locking tabs A A

0.125 in. (3.18 mm)


max. 0.134 0.004 in. 10 to 20 deg
0.173 0.004 in. (3.40 0.10 mm)
(4.40 0.10 mm) O-ring lead in chamfer
0.060 in. (1.52 mm) max.

0.55 in. (14.0 mm) min.

2.250 + 0.003/-0 in.


(57.15 + 0.08/-0 mm)

Section A-A
GENERAL NOTES:
(a) Locking tab retainer options are shown as possible options and do not represent all possible designs.
(b) All surfaces shall meet the specified finish of wetted surfaces, excluding the weld zones.

SD-3.9 Spray Devices (c) The spray pattern, as it exits the device, is deter-
mined by the spray device design. Spray patterns are
SD-3.9.1 General. SD-3.9 covers spray devices
typically streams/jets or fans.
intended for use in bioprocessing equipment, intended
(d) The impact pattern is determined by the interac-
to remain in place or be removed during production.
tion over time of the spray pattern and the geometry of
Recommendations in this section are valid for water
the equipment.
based cleaning solutions. The flow rate recommenda-
tions in this section are for metallic vessels. (e) During design, consideration should be given to
the following in the selection of spray device(s):
(a) Spray devices distribute rinse and cleaning solu-
tions to interior surfaces of bioprocessing equipment by (1) residue characteristics
direct spray and utilize sheeting action for remaining (2) equipment geometry and appurtenances
targeted areas. Spray devices are also used in other appli- (3) physical location and orientation of spray
cations (e.g., water systems to maintain coverage of the device(s)
storage tank head space and in COP cabinet washers). (4) process requirements including air-purge and
(b) The differential pressure across the spray device steaming, if applicable
generates liquid velocity exiting through the spray (5) cleaning system capacity
device orifices, nozzles, or slots. Differential pressure (6) installation of screen/strainer to protect the
and its resulting flow are key parameters of spray functionality of the spray device
devices. Flow is the recommended control parameter (7) cleaning cycle time
because it is independent of temperature and location (8) cleaning chemistry compatibility with materials
of the measurement device. of construction

52

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.8.1.1-2 Tapered Locking Tab Retainer External

R1.43 0.010 in. (36.3 0.25 mm)


clearance for locking tabs

B B

0.125 in. (3.18 mm) max.


Weld zone
0.134 0.004 in. 10 to 20 deg
0.173 0.004 in. (3.40 0.10 mm)
(4.40 0.10 mm) O-ring lead in chamfer
0.060 in. (1.52 mm) max.

0.55 in. (14.0 mm) min.

R0.06 in. (1.5 mm)

2.250 + 0.003/-0 in.


(57.15 + 0.08/-0 mm)

Section: B-B
GENERAL NOTES:
(a) Locking tab retainer options are shown as possible options and do not represent all possible designs.
(b) All surfaces shall meet the specified finish of wetted surfaces, excluding the weld zones.

(9) potential orifice erosion (e.g., from CIP and SIP) the spray device turns a turbine wheel, which typically
(f) Spray devices are either static or dynamic. turns the body around one axis as well as the nozzle(s)
(1) Static spray devices continuously produce a around a second axis creating a repeatable indexed pat-
defined impact pattern by stationary direct spray. Static tern. When motor driven, the body and nozzles are
spray devices have no moving parts. Examples of static turned mechanically by the motor.
spray devices include static spray balls, stationary noz- (g) Spray devices can be designed as removable,
zles, and spray wands. retractable, or to remain in place.
(2) Dynamic spray devices are either single axis or (h) Spray device(s) are specific to the application and
multi-axis. Both produce a defined impact pattern by equipment. Spray devices are generally not interchange-
moving multidirectional spray(s). Dynamic spray device able without considering the specific flow, pressure,
rotation is rinse water/cleaning solution driven or equipment design, spray pattern, and drainability of the
motor driven. Dynamic spray devices have moving spray device(s).
parts, which may include bearings, gears, and turbines
(a) Single axis dynamic spray devices (see SD-3.9.2 Spray Device Requirements (14)
Fig. SD-3.9.1-1). When the orifices/nozzles/slots are (a) Materials of construction shall comply with
manufactured at an angle, the resulting force spins the SD-2.4.1.2 or as otherwise agreed upon with owner/
spray head. Rotation can also be turbine or motor driven. user.
(b) Multi-axis dynamic spray devices rotate in (b) When installed, spray devices shall be drainable
more than a single plane (see Fig. SD-3.9.1-2). When and cleanable inside and outside or otherwise as agreed
rinse water/cleaning solution driven, the flow through upon with owner/user.

53

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.9.1-1 Dynamic Spray Device: Single Axis

GENERAL NOTE: Spray pattern is for illustration purposes.

(14) Fig. SD-3.9.1-2 Two Axes Dynamic Spray Device

GENERAL NOTE: Number of jets is for illustration purposes.

54

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(c) Spray device(s) shall be installed per manufactur- SD-3.9.2.2 Single Axis Dynamic Spray Device
ers instructions. Requirements
(d) When operated within specification, the spray (a) Rotation and/or frequency verification shall be
device(s) shall produce repeatable effective coverage agreed upon with the owner/user.
over a defined area of the equipment. (b) Weld-on or self-cleaning slip-joint/clip-on connec-
(e) Effective coverage shall not be affected by flow tions are acceptable. Other hygienic alternatives shall
rate variations of 10% or otherwise agreed upon by be agreed upon with the owner/user.
owner/user. (c) The flow rate guideline for vertical cylindrical ves-
(f) Spray devices shall be accessible for functionality sels with dished heads is 1.9 gal/min/ft to
verification, inspection, and maintenance. 2.3 gal/min/ft (23.6 L/min/m to 28.6 L/min/m) of
(g) Removable spray device(s) shall be capable of inner vessel circumference. The majority of the flow is
being re-installed in a repeatable manner by unique directed toward the upper head to ensure coverage of
identifiers to ensure proper installation location. appurtenances and provide the sheeting action.
(h) Spray device selection, orientation, and location (d) The flow rate guideline for horizontal cylindrical
shall be designed to ensure the equipment and the tar- vessels with dished-heads is 1.4 gal/min/ft to
geted surfaces of its appurtenances (e.g., manways, dip- 2.1 gal/min/ft (17.4 L/min/m to 26.1 L/min/m) of
tubes, baffles, nozzles, agitator shaft, and impellers) are perimeter (2L + 2D). The majority of the flow is directed
exposed to rinse water/cleaning solution. toward the upper one-third of the vessel to ensure cover-
(i) Spray device(s) shall be provided with a level of age of appurtenances and provide the sheeting action.
documentation that is consistent with the equipment for
(e) Flow requirements for the specific application
which it is to be installed and in accordance with GR-5
should be confirmed with the spray device and/or
documentation requirements.
equipment manufacturer or other subject matter experts.
(j) Process contact surface finishes of spray devices
(f) High-velocity gas flow from air-blows or steam
should be consistent with the equipment for which it is
passing through liquid-driven spray devices can result
installed or otherwise specified by the owner/user and
in accordance with the definitions of Part SF. in wear to bearing surfaces. Consideration should be
(k) Spray devices shall not utilize lubricants that may taken to restrict gas flow through the spray device
or that will come in contact with the product. Dynamic according to the manufacturers recommendation.
devices are typically lubricated by the rinse/cleaning SD-3.9.2.3 Multi-Axis Dynamic Spray Device
solution(s). Requirements
SD-3.9.2.1 Static Spray Device Requirements (a) Rotation and/or frequency verification shall be
(a) Static spray devices shall have a positioning device agreed upon with the owner/end-user.
(preferred) or mark to allow for proper orientation dur- (b) The time to complete a full impact pattern (see
ing re-installation, as static devices are orientation sensi- Fig. SD-3.9.2.3-1) at a specified pressure or flow rate
tive (see Fig. SD-3.9.2.1-1) shall be provided by the manufacturer.
(b) Weld-on or self-cleaning slip-joint/clip-on connec- (c) Weld-on or self-cleaning slip-joint/clip-on connec-
tions are acceptable. Provision shall be made to ensure tions are acceptable. Other hygienic alternatives shall
proper orientation and location if a slip-joint/clip-on be agreed upon with the owner/user.
style static spray device(s) is used.
(d) The flow rate guideline for vertical cylindrical ves-
(c) A portion of the flow is directed toward the spe-
sels with dished heads is 1.3 gal/min/ft to
cific appurtenances.
1.5 gal/min/ft (16.1 L/min/m to 18.6 L/min/m) of
(d) The flow rate guideline for vertical cylindrical ves-
inner vessel circumference to ensure coverage of appur-
sels with dished heads is 2.5 gal/min/ft to 3 gal/min/ft
tenances and provide the sheeting action.
(31 L/min/m to 37 L/min/m) of inner vessel circumfer-
ence. Reference Fig. SD-3.9.2.1-2. The majority of the (e) The flow rate guideline for horizontal cylindrical
flow is directed toward the upper head to ensure cover- vessels with dished-heads is 0.8 gal/min/ft to
age of appurtenances and provide the sheeting action. 1.2 gal/min/ft (9.9 L/min/m to 14.9 L/min/m) of
(e) The flow rate guideline for horizontal cylindrical perimeter (2L + 2D) to ensure coverage of appurtenances
vessels with dished heads is 2 gal/min/ft to and provide the sheeting action.
3 gal/min/ft (25 L/min/m to 37 L/min/m) of perimeter (f) Flow requirements for the specific application
(2L + 2D). Reference Fig. SD-3.9.2.1-3. The majority of should be confirmed with the spray device and/or
the flow is directed toward the upper one-third of the equipment manufacturer or other subject matter experts.
vessel to ensure coverage of appurtenances and provide (g) High velocity gas flow from air-blows or steam
the sheeting action. passing through liquid-driven spray devices can result
(f) Flow requirements for the specific application in wear to bearing surfaces. Consideration should be
should be confirmed with the spray device and/or taken to restrict gas flow through the spray device
equipment manufacturer or other subject matter experts. according to the manufacturers recommendation.

55

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-3.9.2.1-1 Static Spray Device

Locating pin

Alignment bracket
Vessel (Ref.)

Spray holes for nozzle annulus

Drain hole at lowest point

Fig. SD-3.9.2.1-2 Flow Rate Guideline for Vertical Cylindrical Vessels

Multiple Axis Dynamic jet devices Single Axis Dynamic spray devices Static spray devices
Diameter [mm]
300 800 1300 1800 2300 2800
100
360
90
330

80 300

70 270
Flow rate [GPM]

240
Flow rate [LPM]

60
210
50
180

40 150

30 120

90
20
60
10
30

0 0
1 2 3 4 5 6 7 8 9 10
Diameter [ft]

56

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels


Multiple Axis Dynamic jet devices Single Axis Dynamic spray devices Static spray devices
Perimeter (2D+2L) [mm]
300 800 1300 1800 2300 2800
100
360
90
330

80 300

70 270
Flow rate [GPM]

240

Flow rate [LPM]


60
210
50
180

40 150

30 120

90
20
60
10
30

0 0
1 2 3 4 5 6 7 8 9 10
Perimeter (2D+2L) [ft]

Fig. SD-3.9.2.3-1 Impact Pattern Build-Up

Partial Half Full

57

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-3.12-1 Steam Traps for Clean Steam Systems


Radius internal corners
(where practical)

Sealed bellows

Sloped for drainability


(b) Welded Trap
(a) Serviceable Trap

SD-3.10 Disposables That Require Pre-Sterilization be given to ease of assembly and subsequent handling
or Post-Sterilization of sample.
[Reserved for future content] SD-3.11.2.3 Sample Collecting
SD-3.11 Sampling Systems (a) When using single-use collecting devices, consid-
eration shall be given to maximum pressure ratings of
SD-3.11.1 General valves, adaptors, and bags.
(a) Sampling equipment in the biopharmaceutical (b) Consideration should be given to the impact of
industry is used for the collection of samples that then absorption and off-gassing that could lead to nonrepre-
undergo chemical or microbiological evaluation. Sam- sentative samples. Polymeric material requirements for
pling may be either aseptic or non-aseptic. leachables and extractables are listed in Part PM.
(b) Sampling systems shall not adulterate the product,
nor affect the sample characteristics being tested. SD-3.11.3 Non-Aseptic Sampling. [Reserved for
(c) Aseptic sampling systems shall be steamable or future content]
presterilized single-use.
(d) Hygienic sampling systems shall either be cleana- SD-3.12 Steam Traps
ble or single-use. (a) Steam traps are not considered hygienic. Steam
(e) Aseptic sampling systems shall be closed to isolate trap bodies shall have an internal surface finish (exclud-
the process, protect the sample, sample container, and ing the bellows assembly) as agreed to by all parties.
sample transfer process from the environment and to Surface finish specification shall match the clean steam
obtain representative samples. condensate tube finish specification unless the conden-
SD-3.11.2 Aseptic Sampling Systems sate downstream of the trap is used in the process or
sampled for quality assurance.
SD-3.11.2.1 Basic Requirements (b) Where used in process systems, the traps shall be
(a) Steamable sample systems shall meet the relevant capable of effectively venting air.
requirements of SD-2.3.1.1. (c) Where installed on process systems, traps shall be
(b) Sampling systems intended for multiple-use shall maintainable to allow easy examination and cleaning.
be cleanable. Welded traps are acceptable if agreed to by the
(c) Sample valves shall meet the requirement of owner/user.
SG-3.3.2.3.
(d) The trap design and mode of operation shall be
(d) In septum sample devices, the needles shall be
such that the risk of soil attachment to the wetted sur-
sterilized prior to insertion into the vessel or process line.
faces is minimized, especially around the bellows and
(e) Collecting devices shall be designed, connected, seat (see Fig. SD-3.12-1).
and disconnected in ways that maintain the integrity of
(e) The trap shall be sized and installed to operate
the sample.
such that there is no backup of condensate into the
SD-3.11.2.2 Installation. The sampling device process equipment and clean steam system under
shall be installed to maintain the aseptic barrier between operating conditions. Operating conditions include
the product and the environment. Consideration should heat-up, hold, and cool down.

58

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(f) The trap shall be designed such that the normal (e) Relief devices, including discharge piping, shall
mode of mechanical failure will be in the open position. be installed in compliance with applicable codes (e.g.,
(g) Thermostatic steam traps, installed in vertical trap flammable liquids and combustibles in accordance with
legs, are preferred for use in clean steam systems (see NFPA 30).
Fig. SD-3.12-1). (f) Pressure relief valves that are used in product con-
(h) Trap operation/reactivity should be improved by tact applications shall be of hygienic design on both
the installation of an uninsulated section of tubing sides of the valve seat. Crevices and hold-up volumes
upstream of the trap [suggested 12 in. (30 cm) as recom- should be minimized.
mended by supplier] (see Fig. SD-4.2.2-2). (g) Safety pressure relief valves that are used in prod-
uct contact applications shall be of hygienic design up
(14) SD-3.13 Check Valves to the valve seat.
(a) Check valves that are used in product contact (h) Pressure and safety pressure relief valves shall be
applications shall be of hygienic design. They shall be installed in a manner that permits self-draining on both
designed for CIP. Crevices and hold-up volumes should the process and discharge sides of the valve seat.
be minimized. (i) Pressure relief valves that are used in product con-
(b) Check valves in process contact applications tact applications shall be CIP capable. If required for
should be installed in a manner that permits self-drain- CIP or SIP, an override that allows flow through the
ing. Nonself-draining valves may be used for liquid valve shall be included.
streams that flow continuously (e.g., a compendial water (j) Pressure relief valves that are used in product con-
loop) or where valves are wetted with a sanitizing tact applications shall comply with SG-3.3.2.3.
medium when not in use (e.g., chromatography system
that is filled with sodium hydroxide solution between SD-3.16 Liquid Pressure Regulators
uses).
(a) Regulators should be installed to be fully draina-
(c) The flow direction and required orientation for ble through the outlet and/or inlet ports.
drainability should be clearly identified on the device.
(b) There shall be no voids or crevices within the area
Where the valve is integral to equipment (e.g., dia-
wetted by the fluid. Regulator designs, where a portion
phragm pumps, homogenizers, etc.) indication of the
of the valve stem penetrates the sensing diaphragm,
flow direction is not required.
shall be avoided unless provisions are made to avoid
(d) The use of check valves with springs in product entrapment of foreign matter and any leakage through
contact should be avoided. The end-user should deter- the interface between stem and diaphragm, especially
mine whether check valves that use a spring are accept- after SIP.
able for other process contact applications. Applications
(c) Due to the inherent design characteristics of self-
where spring check valves are typically acceptable
contained regulators, manual means of override may be
include condensate removal lines and dry process
required to allow full cleanability and drainability.
gasses.
(e) Check valve design shall comply with SG-3.3.2.3.
SD-4 PROCESS UTILITIES
SD-3.14 Orifice Plates
Orifice plates, when required and used in hygienic SD-4.1 Compendial Water Systems
piping systems, shall be installed in a drainable position. (a) Compendial water systems, such as USP Grade
(14) SD-3.15 Relief Devices Water-for-Injection (WFI), USP Grade Purified Water
(PW), and Highly Purified Water (HPW), shall be
(a) Rupture discs (or other hygienic pressure relief designed as looped circulatory systems, rather than non-
devices approved by the owner/user) shall be installed circulating, dead-ended, branched systems.
in a hygienic manner without compromising the safety (b) Loops shall be designed to provide fully devel-
or efficiency of the system. oped turbulent flow in the circulating sections, and pre-
(b) The cleaning system design shall ensure that the vent stagnation in any branches.
rupture disc (or other hygienic pressure relief devices
approved by the owner/user) will not be damaged by SD-4.1.1 Compendial Water Generation
the cleaning process (e.g., mechanical forces, chemical (a) All surfaces that shall come into direct contact
compatibility, etc.). with the product, feed water, or condensate/blowdown
(c) Rupture disc (or other hygienic pressure relief produced by the units shall be constructed of 316 stain-
devices approved by the owner/user) installation shall less steel with all welded parts of 316L stainless steel
comply with the L/D ratios mentioned in SD-3.1.2.2. or other material as specified by the owner/user.
(d) Rupture discs shall be installed in the manufactur- (b) Connections to the product, feed water, or conden-
ers recommended holder to ensure proper functionality sate/blowdown produced by the units shall be made by
and cleanability. the use of hygienic design fittings. All gasketed fittings

59

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

should be constructed in such a manner as to avoid dead [see Fig. SD-4.1.2.1-1, illustrations (d) and (e)]. The dis-
legs and crevices. tance H of the physical break should be at least twice
(c) Units should be completely drainable and should the inner diameter of the hoses, drain valves, or any
not contain any areas where agents used to clean, de- other component leading to drains or sinks to avoid
scale, and/or passivate the units are trapped or not backsiphoning into the POU assembly. The break shall
easily flushed during rinsing operations. be at least 1 in. (25 mm) for hoses, drain valves, or other
components with internal diameters less than or equal
SD-4.1.2 Compendial Water Distribution Systems
to 12 in. (13 mm) (see Fig. SD-4.1.2.2-1).
SD-4.1.2.1 Point-of-Use Piping Design for (l) Tubing and other piping materials should be a
Compendial Water Systems. Point-of-use (POU) can be minimum of 34 in. (19 mm) in diameter to facilitate free
defined as a location in a compendial water loop where drainage of water after use.
water is accessed for processing and/or sampling. Typi- (m) POU assemblies shall be drainable as indicated
cally, the point-of-use assemblies are composed of the in SD-2.4.3.
following elements: (n) A POU may include a venturi or orifice plate, if
(a) piping associated with a compendial water loop the restriction of water flow is required. Where used,
at the physical POU the additions of these components will require a blow-
(b) POU valves, equipment, and instruments down to ensure drainability.
Additional process components and equipment may (o) When compendial water systems are constructed
be added to satisfy application and/or system require- of 316L stainless steel or other alloy steels, the surface
ments and will be discussed further in this Part (see finish should be less than or equal to 25 in. Ra or 0.6 m
Fig. SD-4.1.2.1-1). (see Part SF) and may be internally electropolished. All
SD-4.1.2.2 Critical Design Criteria for Point-of-Use internal surfaces shall be passivated.
Assemblies (p) When compendial water systems are constructed
(a) All point-of-use (POU) assemblies will be of polymer materials, the surface finish should be less
designed to optimize drainability through the POU than or equal to 25 in. Ra or 0.6 m.
valve.
(b) Assemblies will be designed to promote the ability SD-4.2 Clean/Pure Steam Systems
to CIP, SIP, and/or purge with clean gasses. SD-4.2 is applicable to both clean and pure steam
(c) Valves used in point-of-use applications should be systems.
welded into the water distribution loop where possible.
Current industry designs are available to achieve an L/D SD-4.2.1 Clean/Pure Steam Generation
of 2 or less (see SD-3.1.2.2). (a) All surfaces that come into direct contact with the
(d) Sample valves should be integral to the design of product, feed water, or condensate/blowdown pro-
the primary valve to eliminate dead legs in the system. duced by the units shall be constructed of 316 stainless
(e) Sample valves should be installed only as needed steel with all welded parts of 316L stainless steel or
on the main loop. other material as specified by the owner/user.
(f) Sample valves should be installed where water is (b) Connections to the product, feed water, or conden-
utilized for the process to demonstrate water quality sate/blowdown produced by the units shall be made by
compliance to compendial monographs. the use of hygienic design fittings. All gasketed fittings
(g) Any valve used to provide clean utility services should be constructed in such a manner as to avoid dead
to the POU assembly (e.g., steam or clean gas) should legs and crevices.
be fabricated in such a manner as to achieve an L/D of (c) Units should be completely drainable and should
2 or less downstream from the primary POU valve [see not contain any areas where agents used to clean, de-
Fig. SD-4.1.2.1-1, illustrations (a) and (c)]. scale, and/or passivate the units are trapped or not
(h) The length of tubing from POU valves to process easily flushed during rinsing operations.
equipment should be minimized [see Fig. SD-4.1.2.1-1,
illustrations (a) and (b)]. SD-4.2.2 Clean/Pure Steam Distribution System
(i) If evacuating the system is not possible, appro- (a) The distribution system shall have adequate pro-
priate porting of the primary POU valve should be vision to remove air during start-up and normal opera-
accomplished to facilitate sanitization. tions. The use of air vents installed at locations where
(j) When heat exchangers are used as point-of-use air is likely to be trapped, such as at the ends of steam
coolers [see Fig. SD-4.1.2.1-1, illustration (c)], the design headers, can assist in this requirement.
shall comply with SD-3.6, Heat Exchange Equipment. (b) The horizontal distribution lines should be sloped
(k) Physical breaks shall be employed between hoses, in the direction of flow as indicated in SD-2.4.3. Where
drain valves, or any other component leading to drains necessary, increases in height should be achieved by
or sinks to avoid backsiphoning into the POU assembly vertical risers (see Fig. SD-4.2.2-1).

60

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-4.1.2.1-1 Point-of-Use Piping (14)

Compendial water
Compendial water
distribution loop
distribution loop

Sample point
Process Min. Min.
Min. Clean gas or
equipment
clean steam
connection
Min.
Process
Equipment
Min.
(b) Direct Connect to Equipment
Drain/steam trap/
sample point
Process
Equipment

(a) Hard Piped to Equipment


Compendial water
distribution loop

Compendial water
distribution loop
Physical break
Sink

Min.
Clean gas or
clean steam Drain
Min.
(d) Sink
Heat exchanger TE
(double tubesheet)
Min.
Compendial water
distribution loop
Drain/steam trap/
sample point

Process Hose
Equipment assembly

(c) Integral Heat Exchanger Physical break


Sink / floor

Drain

(e) Hose

61

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-4.1.2.2-1 Physical Break in Point-of-Use Piping

d
H

GENERAL NOTE: H p 2 d or H p 1 in. (25 mm) if d < 12 in. (13 mm).

(c) Adequate provision should be made to allow for the steam system and are subject to continuous steam
line expansion and to prevent sagging of the distribution service.
lines, so that line drainage is not reduced. (a) Valves for steam service shall be designed for
(d) Distribution systems shall not be directly con- drainability and should have minimal fluid hold-up
nected to any nonhygienic steam systems (e.g., plant volumes.
steam systems). (b) Ball valves are an acceptable industry standard for
(e) Trap legs for the collection of condensate from the isolation purposes on continuous steam service. Three-
steam distribution system should be of equal size to the piece-body ball valves should be used instead of single-
distribution line for sizes up to 4 in. (100 mm), and one body designs for both cleanability and maintainability.
or two line sizes smaller for lines of 6 in. (150 mm) or The bore of the ball valve assembly shall match the
larger. These shall be trapped at the bottom. The line inside diameter of the tube (see Fig. SG-2.3.1.3-1).
size reduction can be made after the branch to the trap (c) All components shall be suitable for continuous
leg (see Fig. SD-4.2.2-2). steam service at the temperatures and pressures speci-
(f) Trap legs should be installed at least every 100 ft fied by the owner/user.
(approximately 30 m), upstream of control and isolation (d) Requirements for operation under CIP and SIP
valves, at the bottom of vertical risers, and at any other conditions [see SG-3.3.2.3(a)(11) and (a)(13)] can be
low points. relaxed when agreed to by the owner/user.
(g) Condensate shall be allowed to drain to and from (e) Secondary stem seals with telltale connections are
steam traps. The use of overhead, direct-coupled, pres- not required for steam service.
surized condensate return systems should be avoided (f) Valves shall be accessible for maintenance.
(see Fig. SD-4.2.2-2).
(h) Where possible, all components within the distri- SD-4.3 Process Gases
bution system should be self-draining.
SD-4.3.1 Process Gas Distribution Systems. For this
(i) Dead legs should be avoided by design of runs
section, a process gas distribution system is one that
and the use of steam traps to remove condensate (see
extends from the bulk supply source (including cylin-
Figs. SD-4.2.2-1 and SD-4.2.2-2).
ders) to the points of use (POU) as defined by the owner/
(j) Branches and points-of-use should be routed from
user. Owners/users and their Quality Assurance person-
the top of the steam header to avoid excessive conden-
nel shall demonstrate that their systems comply with
sate loads at the branch (see Fig. SD-4.2.2-2).
21 CFR 211, Subpart D.
(k) Sampling points for clean/pure steam should be
(a) The installation of process gas delivery and distri-
located to collect representative sample(s) of the system
bution systems for use within the scope of this Standard
(e.g., generator outlet, distribution header ends, critical
requires appropriate selection of piping materials. All
points-of-use, autoclaves, or SIP stations).
components shall be supplied or rendered both hydro-
(14) SD-4.2.3 Clean/Pure Steam Valves. SD-4.2.3 covers carbon free (e.g., oil free) and particulate free prior to
isolation, regulation, and control valves that are part of installation and/or use.

62

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-4.2.2-1 Typical Clean Steam System Isometric (14)

Slope
Slope
Slope
Slope in direction
Point-of-Use of steam flow
(typ.)
Thermal
expansion
Min. (typ.) loop

Slope
Sample
cooler

Slope Clean steam


Sample generator
cooler

Ported
ball
valve
(option)
sample

Portable
sample cooler
(option)

GENERAL NOTE: Provide steam traps


(a) where line transitions from horizontal to vertical (at the bottom of the vertical riser)
(b) at least every 100 ft (30 m)
(c) at end of each header or branch
(d) at thermal expansion loops or transitions
(e) where steam is sampled

63

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-4.2.2-2 Clean Steam Point-of-Use Design

Clean steam Trapped condensate


header (with valve closed)
Accepted

Clean steam Clean steam


user specification

12 in. (30 cm) Accepted Not Accepted


uninsulated Clean steam
section condensate
specification
Steam trap

Air gap Clean steam


at drain condensate header

(b) For materials of construction, the owner/user (g) Gas systems testing and sampling shall comply
shall specify all materials. When copper is used, it should with 21 CFR 211 and ICH Q7 (International Conference
be hard drawn and installed in accordance with the on Harmonization, Good Manufacturing Practice
current edition of NFPA 99, Chapter 5. When copper is Guidance for Active Pharmaceutical Ingredients).
specified in a clean room or area, the owner/user shall
confirm that all planned cleaning and sanitizing agents SD-4.4 Process Waste Systems
are compatible with copper and all materials of construc- SD-4.4.1 Bio-Kill Systems. [Reserved for future
tion. When stainless steel tubing is specified, the materi- content]
als of choice are alloys 316L or 304L. Orbital welding is
the recommended joining method. Inside clean rooms,
the piping materials of choice are 316L or 304L stainless SD-5 PROCESS SYSTEMS
steel tubing and fittings. The owner/user and manufac- SD-5.1 Upstream Systems
turer shall agree on all joining methods, levels of inspec-
SD-5.1.1 Bioreactors and Fermentors
tion, and acceptance criteria for all joints prior to
installation. SD-5.1.1.1 General
(c) Compression fittings may be used for valves, regu- (a) Scope. For this section, the terms fermentors and
lators, mass flow controllers, and other instrumentation bioreactors are interchangeable. A bioreactor or fer-
systems at the source and/or within system boundaries. mentor shall be defined as a vessel based system used
(d) Gas systems are not designed or configured with in the growth of microorganisms, plant, mammalian, or
the intent or provisions to be cleaned, passivated, or insect cells.
chemically treated after installation. Features such as (b) The area within the bioreactor sterile envelope or
slope, high point vents, and low point drains need not boundary shall be designed for cleanability and biobur-
be incorporated into these systems. den control. As a minimum, the bioreactor sterile enve-
(e) There shall be no nonvolatile residue. The system lope or boundary shall include the following (see
design shall ensure that gas will remain pure throughout Figs. SD-5.1.1.1-1 and SD-5.1.1.1-2):
its delivery. (1) vessel internals.
(f) It is important to select appropriate pre-filters and (2) inlet gas piping from the filter element(s) to the
final system filters. The final point-of-use gas purity vessel and any installed isolation valving. If redundant
shall comply with the process requirements. sterilizing grade filters are used in series, the inlet filter

64

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-5.1.1.1-1 Fermentor Sterile Envelope

Optional
Indicates sterile boundary
Exhaust
Optional

TE
CIP T T
PI

T
Inoculum

Liquid add

T T
T
Optional

T FIC Air
Nutrient

Probe
(typical) FIC Gas
Optional AE

T
M
PI Sample
Clean assembly
Agitator
steam
seal
T
GENERAL NOTE: Design may vary.

65

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-5.1.1.1-2 Bioreactor Sterile Envelope

Optional
Indicates sterile boundary
Exhaust
Optional

TE
CIP T T
PI

T
Inoculum

Liquid add
T

T T

Optional

T
T FIC Air
Nutrient

Probe
(typical) FIC Gas
Optional AE

T M

PI Sample
Clean assembly
Agitator
steam
seal
T
GENERAL NOTE: Design may vary.

66

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

element farthest from the reactor vessel shall define the shall be capable of being steam sterilized without degra-
sterile boundary. dation to any of the elastomers or polymers that make
(3) exhaust gas piping from the vessel side of the up the components or assemblies.
exhaust filter(s) to the vessel and any installed isolation
valving. If redundant sterilizing grade filters are used SD-5.1.1.2 Inlet Gas Assembly. The inlet gas
in series, the exhaust filter farthest from the reactor ves- assembly shall be defined as a piping assembly that has
sel shall define the sterile boundary. the ability to deliver controlled amounts of filtered gases
into a bioreactor vessel. The assembly shall include but
(4) agitation assembly including all internal sur-
is not limited to the items in SD-5.1.1.2.1 through
faces of the impellers, and shaft up to the mechanical
SD-5.1.1.2.4.
shaft seal in contact with the product.
(5) feed systems from the vessel to the seat of the SD-5.1.1.2.1 Flow Control Devices
isolation valve nearest to the bioreactor vessel or if the (a) Flow control devices (e.g., rotameters, mass flow
feed stream is being filter sterilized, the sterilizing grade controllers, and modulating control valves) shall be
filter element. installed outside of the sterile boundary; therefore, pip-
(6) sampling system. ing requirements within this section may not apply.
(7) product harvesting system from the vessel to However, provisions shall be included within the design
the seat of the isolation valve nearest to the bioreactor to prevent instrumentation damage due to SIP proce-
vessel. dures and backflow.
(c) A bioreactor is made up of a number of subassem- (b) Flow control devices should be sized to prevent
blies, with those subassemblies potentially in contact a vacuum condition, or a provision to bypass the flow
with product, requiring special design consideration for control device shall be provided to maintain positive
cleaning and bioburden control. pressure in the vessel.
(d) The bioreactor design for cleanability and sterility
shall take into consideration the biosafety level require- SD-5.1.1.2.2 Inlet Filter Assembly
ment for the system. A bioreactor shall be designed in (a) For this section, an inlet filter shall be defined as
accordance with a biosafety level requirement as defined a filter element installed in a housing of suitable mate-
by the National Institutes of Health or equivalent organi- rial. The inlet filter assembly shall be defined as the
zation (e.g., BSL-1, BSL-2, BSL-3, or BSL-4). The biosafety filter(s) local to the bioreactor.
level requirement should be determined based on the (b) Inlet filter assemblies shall be designed for SIP
organism, the process, the product being produced, and/ with provisions to remove entrapped air and
or the owner/users preferences. To meet a specific bio- condensate.
safety level requirement, special operational considera- (c) If multiple inlet filters are used in series, then
tions (e.g., steam blocks) may have to be addressed the filter assembly closest to the bioreactor shall be a
within the bioreactors subassembly designs. If the biore- sterilizing filter.
actor has been used to grow an organism that requires (d) Provisions shall be made for integrity testing of
biohazard containment, provision shall be made to the filter assembly in situ or out of place.
decontaminate all surfaces that may have come in con- (e) If the housings are included in a cleaning circuit,
tact with product prior to CIP, or to contain and decon- the filter elements shall be removed prior to introduction
taminate the fluids used for CIP. of cleaning solutions.
(e) The bioreactor vessel should be pressure/vacuum (f) Gas filters should be installed above the bioreactor
and temperature rated per the owner/users design cri- liquid level.
teria. The vessel shall be constructed, tested, inspected,
and stamped in accordance with local ordinances, regu- SD-5.1.1.2.3 Gas Sparging Assemblies
lations, and codes. (a) Spargers shall be defined as mechanical devices
(f) The area within the sterile envelope should be normally located below an impeller used to disperse
designed for CIP. For components that cannot be CIPd, gases within a charged bioreactor. This section applies
the design shall allow removal for manual cleaning out to sparge lances, wands, rings, and other devices (see
of place or replacement. Figs. SD-5.1.1.2.3-1 through SD-5.1.1.2.3-4) that may be
(g) The area within the sterile envelope should be mounted in the bioreactor vessel to introduce various gas
designed for SIP. For those components or assemblies streams for process operations. Sparge device assemblies
that cannot be SIPd, the design shall allow removal shall meet the requirements of SD-3.4.2.
for steam sterilization using an autoclave as long as (b) Spargers shall be designed for SIP with the vessel.
additional provisions are provided for sterilizing the (c) Spargers should be designed for CIP. If the sparge
interface (e.g., steam block) once the components or element cannot be CIPd, provisions shall be made to
assemblies are reconnected to the remainder of the biore- remove the sparge assembly from the bioreactor for
actor system. Autoclaved components or assemblies cleaning out of place or replacement.

67

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-5.1.1.2.3-1 Gas Sparging Assembly Lance

Plan

CIP spray hole


(for mounting ferrule CIP)

CIP drain hole at


lowest point of cap

Elevation

68

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-5.1.1.2.3-2 Gas Sparging Assembly Sintered (14)

Sintered element
removed for CIP

Plan

CIP spray hole


(for mounting ferrule CIP)

CIP drain hole at


lowest point of cap

Elevation

69

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-5.1.1.2.3-3 Gas Sparging Assembly Ring

Plan

CIP spray hole


(for mounting ferrule CIP)

CIP drain hole at


lowest point of cap

Elevation

70

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-5.1.1.2.3-4 Gas Sparging Assembly Single Orifice (14)

Plan

CIP spray hole


(for mounting ferrule CIP)

Elevation

71

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(d) The removable sparger shall be supplied with the steam jacketed, or electrically heated traced filter hous-
means to ensure that the installation orientation is in ings (Fig. SD-5.1.1.3.1-3). These items shall be designed
compliance with design intent. for SIP and CIP.
(e) If the bioreactor is sterilized with media in the
SD-5.1.1.3.2 Exhaust Gas Piping
vessel, the SIP operation shall direct steam flow through
the sparge device. (a) The exhaust gas assembly within the sterile enve-
lope shall meet the requirements as defined in SD-3.1.2.
(f) CIP for sparge devices that use porous material
for gas distribution requires particular attention. These (b) Exhaust gas piping within the sterile envelope
devices should be evaluated for CIP cleanability and shall meet slope requirements as defined for GSD3 in
should be removed from the bioreactor for external Table SD-2.4.3.1-1.
cleaning and/or replacement when CIP is not feasible. (c) The design of exhaust gas piping from the bioreac-
tor should ensure that there is no condensate accumula-
(g) All wetted surfaces shall be sloped to drain by
tion in the line downstream of the system.
gravity into the vessel.
(h) If a check valve is installed in the sparge line SD-5.1.1.3.3 Backpressure Control Devices
within the sterile envelope, it shall be designed for CIP (a) If required, backpressure control devices (e.g.,
and SIP. modulating control valves or regulators) should be
installed outside of the sterile boundary.
SD-5.1.1.2.4 Inlet Gas Piping
(b) Backpressure control devices shall not hinder the
(a) Overlay piping is defined as piping that directs
bioreactors capability of being SIPd and CIPd.
filtered gases to the vessel headspace.
(c) If a vapor-liquid separator is used in the exhaust
(b) Inlet gas assembly piping (sparge and overlay)
within the sterile envelope, it shall be designed for CIP
within the sterile envelope shall meet the requirements
and SIP.
as defined in SD-3.1.2.
(c) Inlet gas piping within the sterile envelope shall SD-5.1.1.4 Piping Systems
meet slope requirements as defined for GSD3 in
Table SD-2.4.3.1-1. SD-5.1.1.4.1 Feed Lines. This section applies to
bioreactor piping systems used to feed liquid ingredients
SD-5.1.1.3 Exhaust Gas Assembly. The exhaust (e.g., pH control reagents, antifoam reagents, media,
gas assembly is defined as a piping assembly that main- nutrient, and inoculum).
tains the integrity of the sterile boundary with respect (a) Feed lines shall be designed with the appropriate
to sterility and pressure. The assembly shall include piping system to allow CIP and SIP of the bioreactor
but is not limited to the items in SD-5.1.1.3.1 through vessel and the feed line itself. CIP and SIP of the feed
SD-5.1.1.3.3. line may be done independently or simultaneously with
the bioreactor.
SD-5.1.1.3.1 Exhaust Filter
(b) If CIP of the ingredient feed system is performed
(a) For this section, an exhaust filter shall be defined
during active culture operations, then the design should
as a filter element installed in a housing of suitable
include provisions to prevent cross contamination
material.
between CIP solutions and product.
(b) Exhaust filters shall be designed for SIP. The hous-
(c) Valve and piping orientation shall be designed to
ings shall be installed in such a way as to prevent the
provide complete drainage during CIP and SIP.
collection of condensate in the elements due to SIP.
(c) If redundant sterilizing grade exhaust filters are SD-5.1.1.4.2 Dip Tubes. This section applies to
used in series, then the filter farthest from the bioreactor all bioreactor port tube-extensions within the vessel.
shall have a maximum rating of 0.2 m absolute. In (a) Bioreactor dip tubes shall meet the requirements
addition, provisions shall be included for draining con- of SD-3.4.2.
densate from the piping between the filters. (b) Removable dip tubes (see Fig. SD-3.4.2-4) shall be
(d) Consideration should be made for CIP or removal inserted through a hygienic fitting. The removable dip
in the case of cleaning out of place. tube shall be supplied with the means to ensure that
(e) Provisions shall be made for integrity testing of the installation orientation is in compliance with design
the exhaust filter. intent.
(f) Filter elements shall be removed prior to introduc- (c) All wetted surfaces shall be sloped to drain by
tion of cleaning solutions into exhaust gas assemblies. gravity into the vessel.
(g) To prevent the exhaust filters from becoming (d) The SIP operation shall direct or balance steam
blinded by condensate saturation during operation, the distribution to establish and maintain sterilization tem-
exhaust gas assembly may include exhaust condensers perature within the tube during the sterilization hold
(Fig. SD-5.1.1.3.1-1), exhaust heaters (Fig. SD-5.1.1.3.1-2), period.

72

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-5.1.1.3.1-1 Exhaust Gas Condenser


Cooling
outlet

Pitch
Vent

Inlet from
vessel
Insulation with
sheathing

Cooling
inlet

Fig. SD-5.1.1.3.1-2 Exhaust Gas Heater


Steam
inlet

Pitch
Vent

Inlet from
vessel
Insulation with
sheathing

Condensate
outlet

73

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14)

Fig. SD-5.1.1.3.1-3 Electrically Heat Traced Filter Housing


Outlet

Insulation with
sheathing

Electric heat trace

Temperature
controller

Inlet from vessel

74

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(e) If the bioreactor is sterilized with media in the (b) Product-contact surfaces of internal coils require
vessel, and the dip tube extends below the working level provisions for CIP and SIP.
of the media, the SIP operation shall direct steam flow
SD-5.1.1.5.4 Baffles. Baffle assemblies shall
through the dip tube into the vessel.
meet the requirements of SD-3.5.
(f) Bioreactor dip tubes shall be designed for CIP or
COP. SD-5.1.1.5.5 Sprayballs/Devices/Wands. This
(g) If the dip tube is installed in the vessel during section applies to sprayballs, wands, and other devices
CIP, both the inside and outside of the dip tube shall (see Fig. SD-3.9.2.1-1) that may be mounted in the biore-
be cleaned. actor vessel for distributing cleaning solution during
CIP operations.
SD-5.1.1.4.3 Harvest Valves/Bottom Outlet (a) Spray device assemblies shall meet the require-
Valve. This section applies to all valves installed in the ments of SD-3.4.2 and SD-3.9.
vessel bottom head. (b) If not removed during processing, spray device
(a) Harvest valves shall meet the requirements of assemblies shall be designed for SIP.
SG-3.3.2.3. (1) The SIP operation shall direct or balance steam
(b) Bottom outlet valves shall be drainable and distribution to establish and maintain sterilization tem-
installed in such a way as to ensure complete drainage perature within the spray device during the sterilization
of the bioreactor contents. hold period.
(c) Bioreactor harvest valves shall be designed for SIP (2) With the exception of a combination sparger/
and CIP or COP. spray device, internal spray devices should be located
above the bioreactor operating liquid level.
SD-5.1.1.5 Miscellaneous Internal Components
(3) If the bioreactor is sterilized with media in the
SD-5.1.1.5.1 Agitation Assemblies. This section vessel, and the spray device assembly extends or is
applies to mechanical agitator assemblies mounted in located beneath the working level of the media, the SIP
the bioreactor for achieving one or more mixing-related operation shall direct steam flow through the device
unit operations (e.g., blending, mass transfer, heat trans- into the vessel.
fer, and solids suspension). SD-5.1.1.6 Instrumentation
(a) Agitators shall meet the requirements of SD-3.5. (a) Instruments installed within the sterile envelope
(b) Agitators with double mechanical seals (see or boundary shall be designed for SIP. Consideration
Fig. SG-2.3.2.3-2) or magnetic couplings (Fig. SD-3.5.5-2) should be made in the design for instrument removal
are recommended to isolate bioreactor contents from the for calibration.
environment. (b) Instruments installed within the sterile envelope
(c) Agitator seal or magnetic coupling components or boundary shall be designed for CIP or removed for
shall be designed for CIP and SIP. COP. In the case of COP, blind caps or plugs should be
(d) Provisions shall be included in the design to clean provided to maintain the integrity of the system.
the product-contact surfaces of impellers. Additional (c) Temperature sensing elements should be installed
spray elements may be required to achieve coverage. in thermowells. Piping associated with in-line ther-
(e) Bottom-mounted agitators shall not interfere with mowells shall be sized to allow sufficient steam and
free and complete drainage of bioreactor contents. condensate flow.
SD-5.1.1.5.2 Mechanical Foam Breaker SD-5.1.2 Cell Disrupters
Assemblies. This section applies to mechanical foam (a) Product contact material shall not affect product
breaker assemblies that may be mounted in the quality or integrity.
bioreactor for reducing or eliminating foam accumula- (b) The device shall be designed with the ability to
tion in the vapor space of the bioreactor. optimize drainability.
(a) Foam breaker assemblies shall meet the require- (c) The design shall incorporate non-shedding com-
ments of SD-3.5. ponents and parts.
(b) Foam breakers with either double mechanical (d) Safety rupture discs shall be oriented for draina-
seals (Fig. SG-2.3.2.3-2) or magnetic couplings bility while maintaining system integrity and safety.
(Fig. SD-3.5.5-2) are recommended to isolate bioreactor (e) The disrupter shall be designed for ease of disas-
contents from the environment. sembly to allow for COP.
(c) Foam breaker seal or magnetic coupling compo- SD-5.1.3 Centrifuges
nents shall be designed for CIP and/or SIP as
appropriate. SD-5.1.3.1 General
(a) Centrifuges designed for CIP and SIP shall have
SD-5.1.1.5.3 Internal Coils all product contact surfaces accessible to the CIP and
(a) Internal coils should be avoided where possible. SIP fluids and be accessible for examination.

75

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(b) Centrifuges that are not designed for CIP or SIP moisture accumulation in vent filters, such as vent heat-
should be easily disassembled and reassembled for ers or condensers, could be considered.
cleaning and examination.
SD-5.2.1.1.1 Cleaning
(c) The owner/user shall inform the manufacturer of
(a) Filtration systems that are designed for cleaning
the cleaning requirements and the bioburden control
in place shall be designed in accordance with SD-2.4.2
method (e.g., temperature, pressure, chemistry).
unless otherwise agreed to by the owner/user and
(d) All crevices and corners, etc., should be accessible
manufacturer.
for visual examination and cleaning.
(b) Tangential flow filtration elements may be
(e) Hexagon socket head cap screws shall not be used
designed for repeated use and cleaned along with the
if they are in contact with the product.
system. When multiple-use elements are cleaned in
(f) No exposed lubricated bearings shall be allowed
place, system design shall ensure suitable conditions
in product contact zones.
(e.g., flow rates) to properly clean the filtration elements.
(g) The centrifuge manufacturer should minimize all
(c) Direct flow filtration elements are typically not
unwanted areas where solids may accumulate. These
reused and are not installed during the cleaning process.
should include threads, gaps between parts, crevices,
etc. The centrifuge manufacturer shall identify all areas SD-5.2.1.1.2 Sanitization. The owner/user is (14)
of primary and incidental product contact that require responsible for defining the sanitization requirements
manual cleaning in addition to CIP. based upon the level of bioburden control required for
the unit operation. All components and filter elements
(14) SD-5.1.3.2 Process Contact Surface Finishes
shall be either compatible with the selected sanitization
(Wetted Surfaces)
agents and conditions, or capable of being removed or
(a) Surface finish specifications shall comply with
isolated prior to the sanitization process while main-
Parts SF and MJ of this Standard.
taining a flow path through the system.
(b) The owner/user and manufacturer shall agree on
(a) Chemical Sanitization. Equipment intended to be
the required finishes for the various parts. The surface
chemically sanitized shall be designed to ensure contact
finish of machined components or parts shall be speci-
between process contact surfaces and the sanitization
fied by the manufacturer and agreed upon by the
solution.
owner/user.
(b) Thermal Sanitization or Sterilization. Temperature,
(c) Provisions should be made for inspection prior to
flow direction, and differential pressure of the thermal
assembly into larger assemblies of subcomponents and
sanitization or sterilization process shall be defined by
parts. Provisions shall be made to enhance the cleanabil-
the owner/user. The properties of the filter elements
ity of the machined surface by use of sloping, draining,
shall be considered to confirm compatibility of the ele-
electropolishing of surface, or other means.
ment with the exposure conditions of a thermal sanitiza-
SD-5.2 Downstream Systems tion process.

SD-5.2.1 Filtration SD-5.2.1.2 Micro/Ultrafiltration Systems (14)


(a) Skid pumps designed for both process and CIP
(14) SD-5.2.1.1 General shall be designed to provide turbulent flow for cleaning.
(a) All wetted surfaces should be accessible for clean- All process piping systems that include piping, tubing,
ing and examination. and fluidic components shall be sloped for adequate
(b) The filter housing shall be designed to allow for drainage. For all low points in the system, a drain port
complete venting and draining. Liquid tee-type filter shall be installed. A common drain port on the skid is
housings should be installed vertically, and vent type preferred.
in-line filter housings should be installed vertically with (b) Piping and equipment hold-up volume shall be
the condensate/drain port directed downward (see minimized.
Fig. SD-5.2.1.1-1).
(c) Ultrafiltration cartridge housings shall be
(c) All nozzle connections shall be of a hygienic designed with connections and covers that will allow
design. the unit to drain completely.
(d) Baffle plates, when used, should be cleanable and
designed for SIP. SD-5.2.1.3 Depth Filtration. [Reserved for future (14)
(e) The housing assembly, tube-sheets, end plates, and content]
connections should be designed to prevent bypassing
SD-5.2.1.4 Tangential/Cross Flow Filtration. (14)
of the product around the element.
[Reserved for future content]
(f) Parts forming internal crevices should be easily
disassembled to enable access for cleaning. SD-5.2.3 Chromatography. For this section, sys-
(g) Vent filters for hot process services should be heat tem is intended to cover the chromatography piping
traced or steam jacketed. Other methods for preventing skid, not including the associated column.

76

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-5.2.1.1-1 Tank/Vessel Vent Filters

Low point drain

(a) In-Line Design (b) T-Type Design


(Accepted) (Accepted)

SD-5.2.3.1 Cleaning. Chromatography systems SD-5.3.2.1 General. For this section, autoclaves
shall be designed for cleaning in place. Systems should and steam sterilizers shall be used synonymously. This
be designed in accordance with SD-3.1 unless otherwise section describes the requirements of autoclaves that are
agreed by owner/user and manufacturer. used in bioprocessing for the steam sterilization of hard,
dry-wrapped, and liquid materials. Autoclave chambers
SD-5.2.3.2 Sanitization
are pressure vessels and shall be pressure and tempera-
(14) SD-5.2.3.2.1 Chemical Sanitization. Chemical ture rated per the owner/users design criteria with a
sanitization processes are used to reduce bioburden. All minimum pressure rating of 25 psig at 266F (1.7 barg
process contact surfaces of system components shall at 130C). The chambers shall also be vacuum rated.
either be compatible with the selected sanitization For systems used in the processing of materials used
agents or be capable of being removed or isolated prior in the European market, autoclaves may also be required
to the sanitization process. Chromatography systems to comply with Pressure Equipment Directive (PED)
are typically stored flooded with a sanitizing solution 97/23/EC and/or EN-285. Special conditions such as
to maintain bioburden control. bio-seals may be required for autoclaves used in BSL-3
SD-5.2.3.2.2 Thermal Sanitization. Chromatog- and BSL-4 applications. Please refer to the Biosafety in
raphy systems may be designed for thermal sanitization. Microbiological and Medical Labs (BMBL) and Centers
However, because it is generally not possible to perform for Disease Control (CDC) guidelines for these special
thermal sanitization of columns, the requirement is often conditions.
waived for chromatography systems. If a system is This section does not pertain to pasteurizers, ETO
designed for thermal sanitization, components shall be (ethylene oxide), VHP (vaporized hydrogen peroxide),
designed for the specified conditions, or shall be or ClO2 (chlorine dioxide) type sterilization equipment.
removed or isolated prior to the sanitization process. The Manufacturer shall define the sterile boundary
Note that if items are removed for sanitization, they of the system.
should be sanitized separately and reinstalled in a con-
trolled environment to avoid contaminating the system. SD-5.3.2.2 Cycle Types. Autoclaves should be
capable of multiple cycle types for various load condi-
SD-5.3 Process Support Systems tions. Autoclaves shall only be used to sterilize the types
of goods for which they are designed. The most common
SD-5.3.1 Washers. [Reserved for future content]
load types are specified in SD-5.3.2.2.1 through
SD-5.3.2 Steam Sterilizers/Autoclaves SD-5.3.2.2.3.

77

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

SD-5.3.2.2.1 Hard Goods Cycles. Hard goods (b) Surface Finish. The surface finish within the sterile
refer to goods such as metallic instruments, containers, boundary need not exceed 35 Ra in. (0.89 m). Electro-
and glassware. Effective removal of noncondensable polishing is not required for steam sterilization systems.
gases is required for effective autoclaving of hard goods. (c) Elastomers. Elastomers shall comply with SG-3.1.1
Hard goods may be wrapped or unwrapped. (Service Temperature), SG-3.1.2 (Service Pressure), and
Unwrapped goods can often be effectively autoclaved SG-3.3 (Seal Construction). Elastomers shall be resistant
using either a single vacuum pull or gravity air displace- to corrosion and to chemical and thermal degradation.
ment. These goods can sometimes be autoclaved at Elastomers used in autoclave applications shall be capa-
higher temperatures. Multiple vacuum pulse precondi- ble of withstanding pressures of a minimum of 25 psig
tioning is required for wrapped goods to ensure proper at 266F (1.7 barg at 130C). Seals should meet the testing
evacuation of noncondensable gases from both the auto- requirements specified in SG-4.2.
clave chamber and autoclaved goods. Steam sterilizers (d) Insulation. External surfaces should be insulated
used for the processing of wrapped or porous goods to minimize heat transmission.
shall be able to pull vacuum to levels below 1 psia
[69 mbar (a)] and maintain the vacuum with a maximum SD-5.3.2.3.2 Doors. Autoclave door(s) shall be
leak rate of 0.1 psi/5 min (6.9 mbar/5 min). Cooling, accessible, cleanable, and replaceable, and should be
drying (pulse, vacuum) is an optional cycle step used capable of undergoing inspection without dismantling.
to dry goods at the end of the autoclave cycle. Heated The door seal shall be resistant to clean steam and clean
pulse drying is also recommended for the drying of steam condensate. The door on the non-sterile side shall
porous goods such as rubber stoppers. Exhaust rates be capable of reopening after closing without undergo-
and heating rates should be adjustable for pressure- ing a cycle. The door(s) shall not be capable of opening
sensitive materials. during a sterilization cycle. The doors shall be con-
structed of materials that are resistant to clean steam
SD-5.3.2.2.2 Liquid Cycles. Forced air removal and clean steam condensate. For multiple-door systems,
preconditioning is an optional cycle used to evacuate the doors shall be interlocked to allow the opening of
the noncondensable gases from the autoclave chamber. only one door at a time. The unloading (sterile-side)
Liquid cooling cycles should be provided to efficiently door shall remain sealed in standby mode. Refer to Part
cool the autoclave chamber. Providing the chamber with SG for specifications of seals used in bioprocessing.
overpressure helps prevent the liquid goods from boiling
over during the cool down phase. Liquids can also be SD-5.3.2.3.3 Sterile Air/Vent Filters. Where the
cooled by slow rate exhaust. Heating rates should be sterilization cycle requires admission of air into the
adjustable to help compensate for differences in heating chamber, the air should be filtered with a sterilizing filter
profiles of items in mixed loads. (0.22 m or less). The filter element shall be replaceable.
Provisions for the steam in place (SIP) of the vent filter
SD-5.3.2.2.3 Air Filter Sterilization. An indepen- elements should be provided.
dent air filter steam in place sterilization (SIP) cycle
should be provided for the in situ sterilization of the SD-5.3.2.3.4 Steam Traps. Refer to SD-3.12 for
chamber vent filters ensuring supply of sterile air for requirements of steam traps.
cool-down phases of autoclave loads.
SD-5.3.2.3.5 Loading Carts/Trays. Carts and
SD-5.3.2.3 Components trays exposed to clean steam shall be constructed of
materials resistant to clean steam and clean steam con-
(14) SD-5.3.2.3.1 General densate. Carts, trays, and chamber shall be accessible or
(a) Materials of Construction. Materials in contact with removable and cleanable.
steam shall resist corrosion from steam and steam con-
densate. The materials shall not affect steam quality and SD-5.3.2.3.6 Valves. Valves and sealing materi-
shall not release any substances known to be toxic or als located within the sterile boundary shall comply
that could adulterate the product. Piping/tubing and with SG-3.3.2.3. Valves within the sterile boundary are
fittings shall be pressure and vacuum tight. The piping/ typically only exposed to clean steam service and chemi-
tubing layout should be designed to eliminate dead-legs cal(s) used during passivation. Exposure to these condi-
within the sterile boundary. Tubing within the sterile tions should be considered when selecting a valve type
boundary should be orbital-welded stainless steel tub- for this application.
ing where possible and shall comply with Part MJ SD-5.3.2.3.7 Check Valves. Provisions to pre-
(Table MJ-8.4-1) acceptance criteria. All process contact vent back-siphoning into the service feed systems should
surfaces within the sterile boundary including tubing, be considered.
chamber, and components shall be passivated.
The autoclave shall be enclosed with paneling that is SD-5.3.2.3.8 Jacket. The jacket shall be con-
resistant to corrosion and is cleanable. structed using materials that are resistant to corrosion

78

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

and degradation from steam or clean steam and clean SD-5.3.3.1.2 CIP System Operating Capabilities
steam condensate, as applicable. (a) The CIP system shall be capable of delivering and
SD-5.3.2.4 Other Features subsequently removing cleaning solutions to soiled
equipment in a verifiable and reproducible manner.
SD-5.3.2.4.1 Drain Temperature. Waste to drain (b) The CIP system shall be capable of removing pro-
temperature shall comply with owner/user specifica- cess soils to an owner/user determined acceptance
tions. The owner/user must specify discharge tempera- criteria.
ture requirements to the manufacturer. (c) The CIP system shall be capable of removing clean-
SD-5.3.2.4.2 Instrumentation. Autoclave pres- ing chemicals to a verifiable amount characteristic of
sure and temperature shall be displayed at all doors. the final rinse solution.
All instruments within the sterile boundary should be SD-5.3.3.1.3 CIP System Functionality
of hygienic design. Instruments shall be capable of being
(a) A CIP system is a distributed system of properly
calibrated and replaced. The instrumentation shall
integrated components including the following:
include the following:
(1) CIP skid (CIP preparation equipment) designed
(a) Temperature. Independent temperature elements
to prepare the cleaning solution. The CIP skid should be
(one or two for monitoring and recording and an inde-
designed to deliver feed water, inject cleaning chemicals,
pendent one for controlling temperature) shall be pro-
heat, and supply the cleaning solution to the soiled
vided. The chamber temperature recording element
equipment. The skid shall also be designed to remove
should be located in the chamber drain. Each tempera-
all residual cleaning chemicals added during the cycle.
ture element shall be accurate to 0.1C (0.18F) with a
(2) CIP distribution equipment designed to trans-
sensor response time <5 sec. The element installation
port the cleaning solution to and from the soiled equip-
shall not affect the maximum leak rate. The temperature
ment. The distribution equipment may also return the
elements shall be temperature and clean steam resistant.
solution to the CIP skid, if applicable.
(b) Pressure/Vacuum. Pressure/vacuum instruments
(3) Spray devices (if applicable) designed to deliver
shall be provided. The pressure instruments shall moni-
the cleaning solutions throughout the soiled process
tor the chamber and jacket pressures. Provisions for
equipment.
recording chamber pressure during active autoclave
(4) Instrumentation and controls architecture (if
cycles shall be included.
applicable) designed to communicate, monitor, and syn-
(c) Date/Time. Provisions for recording the date and
chronize the CIP cycle, and report CIP variables.
time during an autoclave cycle shall be included.
(b) The following cleaning variables should be consid-
(d) Recording may be achieved by paper or 21CFR
ered in the design of the CIP system and CIP cycle:
Part 11 compliant electronic means.
(1) time of exposure (contact time) to wash and
SD-5.3.3 CIP Systems and Design rinse solutions
SD-5.3.3.1 General (2) temperature of wash and rinse solutions
(3) chemical concentration of wash solutions
SD-5.3.3.1.1 Scope and Definitions
(4) fluid hydraulics
(a) The following terms are defined for this section:
(c) A CIP system should include the capability to
(1) Clean-in-place (CIP) system: a system used in the
control directly or indirectly (monitor and record if
preparation, distribution, delivery, and subsequent
applicable) the following CIP variables:
removal of cleaning solutions to soiled equipment.
(1) timing of CIP cycle
(2) CIP cycle: the executed recipe of rinses, washes,
(2) path being cleaned (e.g., valve position indica-
and air blows used to clean soiled equipment.
tion, pressure/flow verification, manual setup
(3) CIP circuit: the sum of paths within a process
verification)
unit operation that are cleaned as part of a single CIP
cycle (e.g., bioreactor, buffer hold vessel). (3) CIP supply temperature (or return if applicable)
(4) CIP path: the specific destination contacted (4) conductivity, volume of cleaning chemical
with cleaning solution/rinse water during a CIP cycle added, or cleaning chemical concentration for wash
(e.g., spray device path, inoculum line path, addition solutions
line path). Multiple paths within a circuit may be cleaned (5) final rinse conductivity or residual cleaning
simultaneously. chemical concentration
(b) All in-circuit components of the CIP system (e.g., (6) CIP supply flow rate
filter housings, pumps, vessels, heat exchangers, transfer (7) totalized flow (if timing not monitored)
panels, instrumentation, valving, piping) shall be (8) CIP supply pressure
designed to be cleanable, drainable, and of hygienic (9) spray device rotation (if used)
design appropriate for use in contact with process fluids (10) interruption or unacceptable decrease in flow
per the applicable sections of this Standard. to a path

79

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(11) pressure of clean compressed air supply (if Table SD-5.3.3.3-1 Flow Rates to Achieve
used in air blow) 5 ft/sec (1.52 m/s)
SD-5.3.3.2 CIP Skid Design Sanitary Tube Size
(a) For this section, a CIP skid consists of a wash O.D. I.D. Flow Rate
and/or rinse tank with all requisite valves, pumps, and in. mm in. mm gpm Lpm
instrumentation. Provision for separation of feed waters
and wash solutions should be considered. CIP skids may 0.5 12.7 0.37 9.4 1.7 6.3
be located in a fixed, centralized location or may be 0.75 19.1 0.62 15.7 4.7 18
1.0 25.4 0.87 22.1 9.3 35
portable and used adjacent to the soiled equipment. 1.5 38.1 1.37 34.8 23 87
(b) The CIP skid design should consider the CIP cir- 2 50.8 1.87 47.5 42.8 162
cuit volume for water consumption, location of skid in
facility (if fixed), chemical consumption, waste effluent,
and energy required to clean a given circuit.
(c) The wash/rinse tank(s) shall be designed and fab-
ricated per SD-3.4. The tank(s) shall be designed for SD-5.3.3.4 Design Guidelines for Cleaning Process
cleanability per SD-5.3.3.4 and shall be equipped with Vessels
a spray device(s) per SD-3.9. (a) Process vessels should be cleaned via internal
(d) If used on wash/rinse tanks, a hydrophobic vent spray device(s) designed to consistently expose all inter-
filter shall be designed to prevent moisture accumula- nal surfaces to the cleaning variables described in
tion in the vent filters and shall be fabricated per SD-5.3.3.
SD-5.2.1. (b) The use and application of a particular spray
(e) Heat exchange equipment shall be designed and device design to satisfy these requirements is to be
fabricated per SD-3.6.1. decided by the owner/user. Spray devices shall be
(f) The CIP skid should have flow control, either via designed and fabricated per SD-3.9 (also see
pump output or by means of flow control valves. Fig. SD-3.9.2.1-1 for static spray device design
(g) CIP supply pumps shall be designed and fabri- considerations).
cated per SD-3.3.2. The pump design should consider (c) Dished-head vertical vessels should have cleaning
the handling of a gas/liquid mixture. solutions delivered with the majority of flow directed
(h) The design should consider hazardous operation toward the upper head and sidewall area at the upper
of cycle considering choice of cleaning chemicals. Chem- knuckle radius. Cylindrical horizontal vessels should
ical segregation, spill control, addition handling, mate- have cleaning solutions delivered with the majority of
rial compatibility, secondary containment, and flow directed toward the upper one-third of the vessel.
personnel safety should be considered. (1) If a static sprayball is used, gravity provides a
solution sheeting over the side wall and bottom head
SD-5.3.3.3 CIP Flow Rate Guidelines for Process (vertical vessels) or lower surfaces (horizontal vessels).
Lines (2) If a dynamic spray device is used, the device
(a) Pipeline should be fully flooded and ensure turbu- may directly spray areas throughout the vessel or rely
lent flow during cleaning. on sheeting action.
(b) CIP shall be performed at a flow rate that main- (3) Figure SD-3.9.2-2 details ranges of flow recom-
tains a fully flooded process line and ensures turbu- mendations for static sprayballs on vertical process ves-
lent flow. sels under typical cleaning loads. The recommendations
(c) The flow direction, line orientation, line size, and in Fig. SD-3.9.2-2 ensure sufficient coverage.
presence and orientation of branches, fittings, and other (4) The criteria to ensure sufficient coverage on
equipment can have a significant influence on the flow horizontal process vessels vary with geometry and size.
rate required to fully flood a process line. Consequently, (5) Sufficient exposure shall be confirmed by cover-
designers should take these into account when age testing per SD-6.1 at site of equipment manufacture
determining suitable flow paths and CIP flow rates. and/or installation.
(d) CIP flow rate requirements should not be consid- (d) Spray device design and location shall ensure
ered exclusively of other CIP process variables. appurtenances such as manways, baffles, dip tubes, agi-
(e) Table SD-5.3.3.3-1 details flow rate recommenda- tator impellers, and nozzles are contacted with cleaning
tions that should ensure air removal in straight hori- solution. Some appurtenances may require additional
zontal and vertical lines for line sizes up to 2 in. These provisions for cleaning.
flow rates correspond to a flow velocity of (e) Spray devices only ensure coverage of the exterior
5 ft/sec (1.52 m/s), which is characterized by turbulent of installed appurtenances and equipment. If not
flow for all CIP solutions that are within the scope of removed during CIP, cleaning solutions shall flow
this section and all line sizes referenced in Part DT. through appurtenances to clean their interior.

80

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(f) The fluid level should be minimized in the process (e) Zero-Static Chains (See Fig. SD-5.3.3.5.1-2)
vessel during CIP. Proper hydraulic balance (supply and (1) For this section, a CIP distribution zero-static
return flow) of the CIP circuit and sizing of the bottom chain shall be defined as a manifold of circuit-specific
outlet valve should be considered to minimize fluid zero-static valves.
level. (2) Provision shall be made to flush the manifold
(g) Vortex formation during CIP may adversely affect in a zero-static chain.
the operation. The installation of a vortex breaker may (f ) Swing Elbows and Piping Spools (See
be required. Fig. SD-5.3.3.5.1-3)
(h) Vortex breaker design is to be decided by the (1) For this section, a swing elbow or piping spool
owner/user. Vortex breaker surfaces shall be sloped to shall be defined as a removable section of pipe used to
eliminate pooling during CIP and positioned to not provide a positive break between two paths.
adversely affect the hydraulic balance of the CIP circuit. (2) Swing elbows or piping spools shall be con-
(i) For process vessels equipped with an agitator, the nected to adequately supported piping to maintain line
impeller should be rotated at an appropriate speed dur- slope and connection alignment.
ing the CIP cycle.
SD-5.3.3.5.2 CIP Distribution Piping
SD-5.3.3.5 CIP Distribution Design (a) The distribution piping and components in a recir-
SD-5.3.3.5.1 CIP Distribution Guidelines (Supply culated CIP circuit shall be hygienic for design and fabri-
and Return) cation as per SD-3.1.2 and SD-2.4.3.
(a) General (b) The distribution piping and components in a once
(1) The use and application of a particular distribu- through CIP circuit or path (not recirculated) shall be
tion design or combination of designs is to be decided hygienic for design and fabrication as per SD-3.1.2 and
by the owner/user. SD-5.3.3.5 discusses design and SD-2.4.3 upstream of the location of cleaning perform-
installation considerations for a series of CIP distribu- ance verification.
tion options. (c) CIP supply piping should be sized to ensure that
(2) All CIP distribution designs shall be sloped for the fluid flow meets or exceeds the guidelines stated in
drainability as per SD-2.4.3. Slope designation GSD2 is sections SD-5.3.2.3 and SD-5.3.2.4.
recommended. (d) The distribution circuits shall be designed such
(3) The use of looped headers, transfer panels, and that fluid flow will maintain a positive pressure relative
valve types (e.g., divert, mix-proof, multiport, zerostatic, to the process drain, preventing backflow.
and diaphragm) should all be considered in the design (e) CIP return piping shall be designed to maintain
of the CIP distribution system. hydraulic balance (supply and return flow) of the CIP
(b) Looped Headers (See Fig. SD-5.3.3.5.1-1) circuit.
(1) For this section, a CIP distribution looped SD-5.3.3.5.3 CIP Return Pumps
header shall be defined as a piping ring surrounded by (a) CIP return pumps (if required) shall be designed
circuit-specific isolation valves. The entire ring path is and fabricated per SD-3.3.2. Centrifugal pumps are pre-
cleaned during a CIP cycle. ferred for CIP return applications. If a gas/liquid mix-
(2) The dimension from the looped header to the ture is anticipated, then hygienic liquid ring pumps are
isolation valve weir or seat should conform to SD-3.1.2.2 recommended.
(see Fig. SD-3.1.2.2-1 for details). The use of short-outlet (b) When a vessel is included in the circuit, CIP return
tees or zero-static valves is to be decided by owner/user. pumps should be placed as close as possible to the vessel
(3) Future connections (if applicable) on the looped bottom outlet and at the low point of the circuit.
header should utilize capped short-outlet tees or capped (c) Provision shall be made to flush through the casing
installed zero-static valves. drain of CIP return pumps.
(4) Looped header connections should be oriented (d) CIP return pumps shall be designed to maintain
horizontally when used in CIP return applications. hydraulic balance (supply and return flow) of the CIP
(5) CIP supply header design should provide for circuit.
adequate velocity in parallel cleaning paths (e.g., line
size reduction in loop header). SD-5.3.3.5.4 CIP Return Eductors. For this sec-
(c) Transfer Panels. Transfer panels shall be designed tion, a CIP return eductor shall be defined as a device
and fabricated per SD-3.7.1. that uses a motive fluid to create a pressure differential
(d) Multiport Valves. For this section, a CIP distribu- that returns the CIP solution.
tion multiport valve shall be defined as a multiple valve (a) CIP return eductors shall be designed and
assembly fabricated as a single body to minimize dis- installed to be drainable.
tances and maximize drainability [see SG-3.3.2.3(a) for (b) CIP return eductors shall be designed to be remov-
details]. able for examination.

81

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SD-5.3.3.5.1-1 CIP Looped Header (Supply or Return)


To/from CIP To/from CIP
circuit or path #1 circuit or path #2
Zero-static
isolation valve
Minimum

Short-outlet tee (future) Capped zero-static


valve (future)
To/from CIP skid

Fig. SD-5.3.3.5.1-2 Zero-Static Chain


Minimum

From CIP skid To CIP


skid or drain

CIP circuit or path CIP circuit or path


#1 supply #2 supply

Fig. SD-5.3.3.5.1-3 Swing Elbow Arrangement


To/from
CIP circuit #2 To/from CIP skid

Swing elbow
transition point To/from
CIP circuit #1

82

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(c) Special design factors shall be considered when SD-5.4.1.2.2 Lyophilizer Chamber
using CIP return eductors (e.g., vapor pressure, return (a) The interior surfaces of the lyophilizer chamber
line size). (chamber vessel) are considered process contact
surfaces.
SD-5.3.4 Ultra High Temperature Sterilizers.
[Reserved for future content] (b) The lyophilizer chamber includes all necessary fit-
tings and closures (e.g., doors, bellows, isolation valves).
SD-5.3.5 Media Prep. [Reserved for future content] The chamber floor shall be self-draining.
(c) The surface finishes of the chamber internal sur-
(14) SD-5.4 Formulation Systems faces (i.e., door, walls, ceiling, and floor) shall be speci-
SD-5.4.1 Lyophilizers/Freeze Dryers fied by the owner/user using the designations in
Table SF-2.4-1.
SD-5.4.1.1 General. For the purpose of this sec- (d) Where the chamber interfaces with the clean room
tion, the terms lyophilizer and freeze dryer may be used or isolator, the surfaces shall meet the owner/users
synonymously. This section describes the requirements specified requirements.
for cleanability and bioburden control of lyophilizers
that are used for biopharmaceutical processing. A lyoph- SD-5.4.1.2.3 Condenser Vessel
ilizer comprises a number of interconnected compo- (a) The condenser vessel, used to contain the con-
nents. Components with process contact surfaces and/ denser heat exchanger, is connected to the chamber ves-
or product contact surfaces shall be designed for clean- sel and may be separated by a main isolation valve.
ability and bioburden control. (b) All surfaces shall be self-draining.
Lyophilizer surfaces of components, piping, equip- (c) In systems designed with back-streaming preven-
ment, or systems that are isolated by design from both tion (i.e., prevention of reverse flow from the vacuum
product and process fluids are not process contact sur- pumps), the condenser vessel is downstream of the
faces nor required to be designed for cleanability or chamber. The condenser vessel surfaces are not process
bioburden control. Examples of surfaces that are not contact surfaces and do not have surface finish
process contact surfaces include the exterior surfaces
requirements.
of equipment, drain lines, vacuum lines, and systems
(d) In systems not designed with back-streaming pre-
containing hydronic or hydraulic fluids.
vention, the condenser vessel surfaces are process con-
SD-5.4.1.2 Components. A lyophilizer is com- tact surfaces. The surface finishes of the condenser vessel
prised of functional components/systems, as shown in shall be specified by the owner/user using the
Fig. 5.4.1.2-1, which are designed for isolation, designations in Table SF-2.4-1.
cleanability, and/or bioburden control. These compo-
nents/systems have the potential to affect product qual- SD-5.4.1.2.4 Lyophilizer Shelves
ity and include the following: (a) The flat surfaces of shelves supporting containers
(a) lyophilizer chamber of product (e.g., vials containing product) are considered
(b) condenser vessel process contact surfaces.
(c) lyophilizer shelves (b) The flat surfaces of shelves are considered product
(d) vacuum systems contact surfaces if product without containers is placed
(e) isolation bellows directly on the shelves.
(f) internal moving parts (c) Surfaces of the structural components of the
(g) spray devices shelves are considered process contact surfaces.
(h) gas filter assemblies (d) The shelf heat transfer performance depends on
(i) doors and door seals shelf flatness. The loading/unloading and initial con-
(j) valves tainer closure performance requires the shelves to be
level. Therefore, shelves are not required to be sloped.
(k) instruments
Methods other than self-draining may be required to
SD-5.4.1.2.1 General remove residual CIP liquid (e.g., collapsible shelves may
(a) All components shall be rated for the applicable be contracted to remove residual CIP liquid from shelf
pressure, vacuum, temperature range, thermal shock, surfaces followed by a process that facilitates drying,
and exposure to sanitizing agents [e.g., VHP (Vaporized such as SIP followed by a vacuum hold).
Hydrogen Peroxide)] when applicable. (e) The surface finishes of shelves shall be specified
(b) Process contact surfaces made from metallic mate- by the owner/user using the designations in
rial should comply with SD-2.4.1.1 through SD-2.4.1.3. Table SF-2.4-1. A rougher surface may be specified for
(c) Process contact surfaces made from nonmetallic the bottom side of the shelves by the owner/user to
material should comply with SD-2.4.1.1, SD-2.4.1.2, meet process requirements (e.g., stopper adhesion
SD-2.4.1.4, and Part PM. prevention).

83

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-5.4.1.2-1 Typical Lyophilizer Component Assembly


Condenser vacuum Condenser relief valve
isolation valve

Condenser SIP/CIP
inlet valve
Hydraulic cylinder for
moving shelves

Vacuum
system

Condenser vessel

Liquid ring
vacuum
pump

CIP inlet

Steam inlet

Chamber relief valve

Gas filter assembly

Isolation bellows

Chamber shelves
Chamber vessel
Chamber door

CIP spray nozzles


inside chamber

84

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

SD-5.4.1.2.5 Vacuum Systems SD-5.4.1.2.8 Spray Devices


(a) The lyophilizer vacuum pumps and condenser (a) Spray devices are used in lyophilizers to facilitate
cooler establish a pressure gradient during lyophiliza- the cleaning of surfaces inside the chamber and con-
tion from the chamber vessel through the condenser denser vessels. Spray devices in the condenser vessel
vessel resulting in single direction flow toward the may also be used for directing spray at the condenser
lyophilizer vacuum pumps. To maintain an environment cooler to facilitate defrosting of the condenser cooler.
appropriate for aseptic processing in the chamber vessel, (b) Spray devices designed for cleaning should pro-
the vacuum system shall prevent reverse flow vide sufficient flow and force to clean flat surfaces (e.g.,
(backstreaming). shelves) by direct spray. Cleaning the internal surfaces
(b) The lyophilizer vacuum pumps are not hygienic of a lyophilizer by direct spray may require a supply
components and should be designed to be outside the pressure and flow rate that are substantially higher than
sterile boundary. are typical for cleaning an empty vessel. The supply
(c) Where vacuum pumps for wet service (e.g., liquid pressure and flow rate should meet the manufacturers
ring vacuum pumps) are used to evacuate air/vapor recommendation for these spray devices.
from the chamber and condenser vessels, they should (c) Both static and dynamic spray devices are accept-
be located outside the sterile boundary. able for use in lyophilizers. The use and application of
a particular spray device design should be agreed upon
SD-5.4.1.2.6 Isolation Bellows among the owner/user, lyophilizer manufacturer, and
(a) Isolation bellows are employed to isolate nonhy- CIP system integrator. The number of spray devices may
gienic moving components from the lyophilizer sterile be reduced if the shelves are allowed to move during
boundary. cleaning. Spraying of shelves should be designed to
(b) The surfaces of the bellows and its mounting con- avoid the interference of spray streams of opposing
nections exposed to the inside of the lyophilizer are directions.
considered process contact surfaces and should be (d) The use of threaded connections for spray devices
assessed for cleanability. The bellows shall be extended shall be agreed upon by the owner/user.
during the cleaning cycle to provide access to all exposed (e) Spray devices shall meet the provisions of SD-3.9.2.
process contact surfaces. (f) Spray device design, location, and orientation shall
(c) The bellows shall be sealed at each end to isolate ensure appurtenances (e.g., nozzles, bellows, shelf sup-
the inside of the lyophilizer from external conditions. ports, and hoses) are exposed to complete spray
Bellows may be bolted or welded into place. A bellows coverage.
sealed by a bolted flange connection with an O-ring seal
within the chamber vessel facilitates replacement and SD-5.4.1.2.9 Gas Filter Assemblies
maintenance. The inside of the bellows may be evacu- (a) For the purpose of this paragraph, the gas filter
ated, vented, or pressurized to facilitate retraction or assembly is defined as those filters installed for the pur-
extension of the bellows. The lyophilizer may be pro- pose of filtering process gases supplied to the lyophi-
vided with a leak-test system to ensure the bellows are lizer. The filter assembly includes the filter media, seals,
intact. housing, and connected tubing.
(d) When specified, the bellows shall be suitable for (b) The last filter in the path of the gas to the lyophi-
sterilization and shall allow for full penetration of the lizer (proximal filter) shall be part of the sterile boundary
sterilizing agent at all surfaces inside the sterile and be designed for the chosen means of bioburden
boundary. reduction (e.g., SIP or VHP). This filter shall be a steriliz-
ing grade filter. If a redundant sterilizing filter is utilized,
SD-5.4.1.2.7 Internal Moving Parts. The follow- both filters shall be included within the sterile boundary.
ing should be considered in the design of moving parts (c) Filter assemblies that are steamed in place shall
(e.g., the raising and lowering of the shelves) within the be designed to
chamber and/or condenser vessels: (1) limit the pressure drop across the filter to within
(a) Nonmetallic material may be used for moving the manufacturers specifications in the specified flow
parts in order to reduce friction (e.g., PTFE, PEEK, direction
UHMWPE). The selection of the material should con- (2) permit temperature monitoring in a location
sider minimizing particle generation. representative of the coldest location
(b) Contact surfaces between moving parts shall be (3) accommodate the integrity testing of the proxi-
exposed to solutions used for cleaning and bioburden mal filter, either in situ or out of place
control. (d) If CIP of the gas filter assembly is specified, provi-
(c) A bellows may be used to isolate the chamber sions shall be made in the design for removal of the
and/or condenser from moving parts that are not of filter element(s) prior to the CIP. Filter elements shall
hygienic design. be reinstalled prior to sterilization of the filter assembly.

85

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

SD-5.4.1.2.10 Doors and Door Seals SD-5.4.1.2.12 Instruments


(a) Lyophilizer doors and door seals shall be designed (a) All instruments within the sterile boundary
to withstand vacuum, cleaning, and sterilization should comply with all applicable sections of Part PI,
conditions. including PI-2.1, PI-2.1.1(c), PI-2.1.1(f), and PI-2.2.2.
(b) Lyophilizer doors shall be accessible, cleanable, (b) Instruments in process contact should be of
and replaceable and should be capable of undergoing hygienic design.
inspection without dismantling. (c) Instrument probe surfaces and side port penetra-
(c) For multiple-door systems, the doors shall be tions shall be oriented for self-drainage.
interlocked to allow the opening of only one door at a (d) Instruments installed within the sterile boundary
time during normal operation. should be designed for CIP and sterilization. Instru-
(d) Doors and locking hardware that interface with ments not designed for CIP should be removed for clean-
the clean room should not be retracted to uncontrolled ing and reinstalled for sterilization.
space. (e) Locations with product-sensing instruments (e.g.,
(e) Both sliding and swing door designs are thermocouples and RTDs) and wire lead-throughs
acceptable. should be considered when designing for cleaning and
(f) Door seals can be made with either static or inflat- sterilization.
able seals. Static seal grooves that hold the seal may be (f) Instrumentation with integral seals or diaphragm
either on the door or the chamber. seals is preferred within the sterile boundary. The risk
(g) The seal groove may be set back from the chamber of using instrumentation without integral seals or dia-
flange edge to keep the seal in position during vacuum phragm seals (e.g., Pirani gages) should be assessed
conditions. based on the risk to product quality as determined by
(h) Compression of a single static seal to achieve a the owner/user.
metal-to-metal contact is preferred to avoid a gap SD-5.4.1.3 Sterile Boundary. For the purpose of
between door and chamber vessel. identifying areas that should be exposed to sterilizing
(i) The door static-seal design shall provide access for agents, the following area within the chamber and con-
manual sanitization as the seal face under compression denser vessels define the sterile boundary as indicated
does not permit penetration of sterilizing agents. in Fig. 5.4.1.3-1:
(j) A combination (static and inflatable) seal design (a) The inside surfaces of the chamber vessel to the
with the static seal circumscribing the inflatable seal chamber door isolation seal.
provides for penetration of sterilizing agents across the (b) The inside surface of the condenser vessel to the
sealing face of the inflatable seal. condenser door isolation seal.
(k) Door seal lubricants shall not be used in aseptic (c) The chamber and condenser drains to the first
processing applications. isolation drain valve.
(l) Refer to Part SG for specifications of seals used in (d) The vacuum pump inlet connection in the con-
bioprocessing. denser vessel to the first isolation vacuum valve closest
SD-5.4.1.2.11 Valves to condenser vessel.
(a) Valve design and selection for service shall follow (e) The vacuum break/gas inlet line to the sterile gas
SG-3.3.2.3(a) and Part SD as appropriate. The application filter. If redundant sterilizing filters in series are used,
of a specific valve type for a given service should be the sterile boundary ends at the membrane of the filter
agreed upon by the manufacturer and owner/user. farthest from the chamber vessel.
(b) Hygienic valves shall be used inside the sterile (f) The CIP/SIP inlet lines to the first CIP/SIP isola-
boundary. tion valve that is closed during the lyophilization
process.
(c) Diaphragm valves are acceptable for hygienic
fluid service. (g) The sealing surface on all instruments connected
to the chamber and condenser vessels.
(d) Butterfly valves may be used as part of the sterile
(h) Thermocouple/RTD seals connected directly to
boundary when piping/tubing is larger than 2 in. in
the chamber and condenser vessels.
diameter.
(i) The exposed surface of the pressure relief valve or
(e) Ball valves may be used outside the sterile bound-
rupture disk.
ary to establish positive isolation.
(f) Pressure relief devices or rupture discs of hygienic SD-5.4.1.4 Internal Connections and Fasteners
design may be used as part of the sterile boundary. (a) Threads sealed by an O-ring or hygienic gasket
(g) If the lyophilizer is designed for isolation between are acceptable. The use of exposed threads within the
the chamber and condenser, the isolation valve may take lyophilizer sterile boundary should be avoided. If other
the form of a mushroom valve, butterfly valve, or other means of fastening are not practical, the use of exposed
proprietary valve design. threads may be permitted with the agreement of the

86

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SD-5.4.1.3-1 Lyophilizer Sterile Boundary


Instrument sealing surfaces
on chamber and condenser

Sealing surface of pressure relief


valve on chamber

CIP/SIP inlet
connections Sealing surface of
Thermocouple/RTD seals
to the first pressure relief
connected to chamber
isolation valves valve on condenser
and condenser
Vacuum pump inlet
connection to the
first isolation valve
Inside
chamber

Condensing Plates
or Coils Inside condenser
Shelves
Vacuum break/gas
inlet line to sterile
gas filter
Condenser

Chamber

Chamber and condenser drains up to


first isolation valve

owner/user. The surfaces of exposed threads should be coverage shall be agreed to by the manufacturer and
among those assessed for cleaning and penetration of owner/user. Nonmandatory Appendix L provides an
sterilizing agents. acceptable procedure for spray device coverage testing.
(b) For process contact surfaces, the use of pins, clevis (d) The process contact surfaces within the condenser
rods, snap rings, and clips may be required to mount vessel may be cleaned via internal spray devices to pro-
hardware inside the sterile boundary but should be min- vide the coverage agreed upon between the manufac-
imized and agreed upon by the owner/user. The sur- turer and owner/user.
faces of these fasteners should be among those assessed (e) Internal liquid distribution piping shall be sloped
for cleaning and penetration of sterilizing agents. to meet the requirements of GSD2 to facilitate gravity
(c) Socket head cap screws and counter bored holes draining.
inside the sterile boundary shall only be used with the (f ) External liquid distribution piping shall be
agreement of the owner/user. designed with valve actions that facilitate gravity drain-
SD-5.4.1.5 CIP of Lyophilizers ing. The pipe slope shall meet the requirements of GSD2.
(a) Systems used to clean lyophilizers shall comply (g) The liquid level in the chamber and condenser
with SD-5.3.3.1.2. Cleanability requirements of SD-2.4.2 vessels should be minimized during once-through CIP
are applicable to lyophilizers except for SD-2.4.2(b)(1), by correct sizing of the drain and by providing slope to
which does not apply to lyophilizer shelves. the respective drain. A CIP drain pump may be used
(b) It is accepted practice to use water as the CIP to assist draining of the chamber and condenser vessels.
fluid for cleaning water soluble compounds. Water for (h) When recirculated CIP is used, the following
injection shall be used for the final rinse in aseptic pro- requirements apply:
cessing applications. (1) Recirculated systems shall be drainable includ-
(c) The chamber vessel, which includes internal ing pump casing(s).
shelves, should be cleaned via internal spray devices (2) Recirculated systems shall be capable of remov-
designed to provide coverage of targeted surfaces. Risk ing residual chemicals and debris during the final rinse.
to product quality should be considered when determin- (i) The chamber and condenser vessels shall be self-
ing the required coverage. The acceptance criteria for drainable.

87

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(1) Process contact surfaces shall be sloped to meet SD-5.4.1.6.2 Hydrogen Peroxide Sterilization.
the requirements of GSD3 for drainage of CIP fluids When designing lyophilizers for sterilization with
and to prevent the collection of condensate during the hydrogen peroxide gas under vacuum
steaming processes. (a) the system should be designed to be dried and
(2) Interior surfaces of nozzles penetrating the ver- have a surface temperature that meets the suppliers
tical walls of the vessel shall be sloped to meet the specification for the hydrogen peroxide supply system
requirements of GSD3. [typically 59F (15C) and 176F (80C)] prior to the start
(3) The floor of the vessel shall be sloped toward of the sterilization process.
the drain connection to meet the requirements of GSD3, (b) the system should be designed to verify that the
unless otherwise agreed to by the manufacturer and residual hydrogen peroxide levels are below the estab-
owner/user. lished thresholds, after the sterilization process has been
completed. Threshold levels should be agreed upon by
SD-5.4.1.6 Bioburden Reduction in Lyophilizers. the owner/user for both operators safety and the poten-
Lyophilizers designed for bioburden control should con- tial impact on the product quality.
sider the following:
SD-5.4.1.7 Leak Rate
(a) Pressure or vacuum hold testing in preparation for
the bioburden reduction process. Refer to leak detection (a) Lyophilizers designed for aseptic lyophilization
para. SD-5.4.1.7. processes shall be designed to meet leak-rate testing
criteria as agreed to by the owner/user. The sterile
(b) Evacuation of air from the chamber and condenser
boundary should be leak tested before aseptic opera-
vessels to reduce the potential for air to be trapped
tions begin. The leak rate is calculated as follows:
during the bioburden reduction process. Effective air
evacuation may be achieved through the use of a liquid PV
ring vacuum pump or similar. Q, mbar-L/sec p
t

SD-5.4.1.6.1 Steam-in-Place (SIP). When where


designing lyophilizers for steam-in-place (SIP) Q p leak rate
(a) steam should enter the lyophilizer at only one V p the lyophilizer system volume subject to the
point at a time to minimize the potential to trap air or vacuum, adjusted to exclude the volume occu-
condensate. If steam needs to enter through multiple pied by internal hardware, L
locations simultaneously, the design should create flow P p the absolute pressure rise during the test
paths that avoid air entrapment. The design should (mbar)
ensure that condensate will freely flow toward low point t p the test duration, sec
drains.
(b) a dual control design may be used to deliver high (b) Leak rate testing should be performed on a clean,
steam flow rates that are often required during the heat- dry, and fully assembled and insulated system with the
ing phase and to maintain tight control of temperature condenser cooler in operation to capture residual vapor.
and pressure during the exposure phase. For example, Typically, leak rates less than 0.02 mbar-L/sec are accept-
one regulator and/or control valve may be used for the able for new installations. Leak rate testing is intended
heating phase and a separate regulator and/or control to confirm vacuum integrity of the system.
valve may be used for tight control during the exposure (c) Leak rate tests are performed at high vacuum con-
phase. ditions with an absolute pressure typically on the order
(c) a vacuum drying phase should be used to elimi- of 0.01 mbar.
nate any condensate remaining within the sterile bound- (d) Sufficient stabilization time will avoid misinter-
ary following SIP. pretation of the vacuum leak rate due to virtual leaks.
(d) if cooling and drying is accomplished with the Virtual leaks are identified by a leak rate that stabilizes
introduction of a process gas with open drains, a positive over time.
pressure differential shall be maintained to preserve the (e) Individual component assemblies, which are sub-
sterile boundary during this operation. jected to vacuum conditions, should be helium leak
tested prior to final installation.
(e) temperature monitored throughout the SIP cycle
should include coldest (worst case) locations. If routine SD-5.4.1.8 Branch Connections
monitoring of worst-case locations is not practical, the (a) The provisions of SD-3.1.2.2 are applicable to
temperature of locations that have been correlated to the liquid-service process-contact piping leading to the
actual worst-case locations may be monitored instead. lyophilizer.
(f) to minimize cold locations during SIP, horizontal (b) Nozzles within the sterile boundary should be
penetrations should be sloped to allow condensate to designed to allow for full exposure to the sterilizing
drain. agent.

88

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(c) Nozzles and other appurtenances that are cleaned (a) Hydrostatic testing shall use clean purified or
by liquid spraying should allow complete coverage. deionized water filtered at 25 microns or better, unless
(d) Lyophilizer internals should be designed to avoid otherwise agreed to by owner/user.
low points where fluid can be trapped. (b) Pneumatic testing shall use oil-free clean dry air,
nitrogen, or inert gas filtered at 25 microns or better,
(14) SD-6 DESIGN CONFORMANCE TESTING unless otherwise agreed to by owner/user.
Design conformance testing shall not result in the
SD-6.4 Vessel Drainability Test
formation of any surface anomalies or contamination.
All design conformance tests and test results documen- Specific steps or operations in a bioprocess may
tation shall have the date and time recorded. Each test require vessels to be self-draining. A drainability test
document shall include a record of personnel who per- for such vessels shall be conducted as agreed to by all
formed and confirmed the test results. parties. As a proposed test procedure, the following
should be considered:
SD-6.1 Spray Device Coverage Test
(a) The vessel shall be leveled for drainability per its
An acceptable spray device coverage test procedure design (e.g., the bottom head of the vessel can be leveled
is provided in Nonmandatory Appendix L. The purpose with the outlet nozzle flange face) and within a tolerance
of the spray device coverage test is to demonstrate and agreed to by owner/user.
document liquid coverage of the process contact sur- (b) The vessel shall be filled approximately to the
faces. The test provides information about liquid cover- weld seam that joins the shell to the bottom head.
age and the conditions necessary to achieve this
(c) The outlet valve shall be opened, the vessel shall
coverage as a prerequisite for cleaning of the process
be vented to atmosphere, and the vessel shall be allowed
equipment. Effective coverage shall be visually deter-
to drain by gravity.
mined using a fluorescent solution and an ultraviolet
(d) There shall be no puddles of water left on the
lamp or by other verification methods as agreed to by
bottom of the vessel greater than as agreed to by the
the owner/user and manufacturer. The minimum
owner/user and manufacturer.
acceptable water quality is noncompendial purified
water (e.g., reverse osmosis or deionized). Acceptance It is generally understood that residual water may be
criteria and coverage test protocol should be agreed to present in the form of droplets that typically do not
by the owner/user and manufacturer. exceed a diameter of 5 mm. Residual water droplets
Spray device coverage tests are not intended to dem- adhere to process surfaces due to surface tension and
onstrate system cleanability. System cleanability is are not indicative of a vessels drainability. Observed
achieved through the equipment design, the spray puddles that are displaced with a 1.0-in. (25-mm) rubber
design, knowledge of the soils, cleaning agent selection, dowel applied perpendicular to the puddle and reform
and cleaning process parameters. Cleanability is verified at the point of displacement indicate a flat or unintended
using a complete CIP per protocol during cleaning low point, and that area shall be repaired to the satisfac-
validation. tion of the owner/user. Puddles that are displaced with
a 1.0-in. (25-mm) diameter rubber dowel applied per-
SD-6.2 Cleaning, Steaming, and Bioburden Control pendicular to the puddle and do not return to the point
Testing of displacement are considered to be large droplets and
Cleaning, steaming, and bioburden control testing (in do not constitute a test failure.
addition to spray device testing) shall be as agreed to
NOTE: Filter housings are available in several designs. In some
by the owner/user and manufacturer, and in accordance
cases, flat bottom filter housings are specified by the owner/user
with accepted industry standards. based on their risk-assessed process and equipment requirements.
Flat bottom cartridge mount filter housings, including those that
SD-6.3 Fluid Requirements for Leak Testing
will be steamed in place, are exempt from this test, and the equip-
Where leak testing is required, the following fluids ment shall be installed as agreed by the manufacturer and
shall be used: owner/user.

89

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Part DT
Dimensions and Tolerances for Process Components

DT-1 PURPOSE AND SCOPE All sizes shown in these tables are nominal O.D.
tube sizes.
The purpose of this Part is to provide requirements
All automatic weld end fittings shall have minimum
that ensure process component fit-up and compatibility.
tangent lengths per Table DT-4.1-1. The tangent length,
This Part specifies dimensions, tolerances, and all
T, is defined as the straight length measured from the
supplementary conditions for process components.
welding end.
The categorized groups in DT-4.1.1 through DT-4.1.5
DT-2 PRESSURE RATING designate specific fitting dimensions.

Fittings manufactured to this Part shall meet or exceed DT-4.1.1 Elbows/Bends. Refer to Tables DT-4.1.1-1
the pressure ratings shown in Table DT-2-1, and shall through DT-4.1.1-8.
have an ambient temperature bursting strength of at DT-4.1.2 Tees/Crosses. Refer to Tables DT-4.1.2-1
least three times the 100F rated internal working pres- through DT-4.1.2-11.
sure as shown in Table DT-2-1 (see also Fig. DT-2-1).
Fabricated components employing welds shall be DT-4.1.3 Reducers. Refer to Tables DT-4.1.3-1
rated at 100% of the above ratings. through DT-4.1.3-3.
Valves manufactured to this Part shall be rated per DT-4.1.4 Ferrules. Refer to Table DT-4.1.4-1. (14)
the manufacturers marked pressure and temperature Hygienic clamp ferrule dimensions are specified in
recommendations. Table DT-7-1.
DT-4.1.5 Caps. Refer to Tables DT-4.1.5-1 and
DT-3 WALL THICKNESS DT-4.1.5-2.
The nominal wall thickness of the fittings and process DT-4.2 Nonstandard Fitting Dimensions
components at the point of joining shall be the same as Fittings not specifically described in Tables DT-4.1.1-1
the tube to which they are welded. The thickness of the through DT-4.1.5-2 may be constructed using combina-
weld ends shall conform with the tolerances listed in tions of centerline-to-end dimensions from the tables.
Tables DT-3-1 and DT-3-2. For tees and crosses, use Tables DT-4.1.2-4 and
After fabrication and surface treatment, the wall thick- DT-4.1.2-8 for standard clamp leg lengths,
ness in any formed part of the fitting or process compo- Tables DT-4.1.2-2 and DT-4.1.2-7 for short outlet branch
nent, beyond the control portion as defined in DT-7, clamp lengths, Table DT-4.1.2-3 for short outlet run
shall be a minimum of 65% of the nominal wall thickness. clamp lengths, and Table DT-4.1.2-1 for weld end
For guidelines regarding all shop and field welds, refer lengths. Consideration shall be made for clamp clear-
to Part MJ. All welds shall meet the provisions of MJ-8 ances when fabricating fittings not depicted in
and Fig. MJ-8.4-1. Tables DT-4.1.1-1 through DT-4.1.5-2.

DT-4.3 Special Angle Fittings Dimensions (14)


(14) DT-4 DIMENSIONS
Special angle fittings can be offered if in accordance
Process components are designed for use with nomi- with all DT tables, with the exception of O (off angle)
nal outside diameter (O.D.) tubing for the sizes listed in Table DT-3-1. Fittings furnished to this Standard shall
in Table DT-4-1. The dimensions are accompanied with not be mitered.
soft metric conversions from the U.S. Customary units,
and are listed for reference only (Ref. GR-6). For nominal DT-4.4 Valve Dimensions
metric size tubing and fittings, refer to the appropriate The dimensions of the valve or valve fabrication shall
international standards. conform to manufacturers standards, or as agreed to
by the purchaser and manufacturer.
DT-4.1 Fitting Dimensions Standard dimensions for valve weld end connections
Dimensions for fittings that are governed by this covered by this Standard are given in Table DT-4.4.1-1.
Standard are grouped and categorized into tables. All sizes shown are nominal O.D. tube sizes.

90

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

The categorized group in DT-4.4.1 designates specific DT-9.2 Hygienic Gaskets


valve dimensions. Fittings and process components with hygienic clamp
DT-4.4.1 Diaphragm Valves. Refer to unions furnished to this Standard shall employ gasket
Table DT-4.4.1-1. materials and gasket designs that meet the requirements
of Table DT-2-1 and Part SG. Gasket seal performance
in the clamp union shall be based on the principles of
DT-5 MATERIALS SG-4 and shall comply with the dimensional require-
Materials used in the manufacture of fittings and other ments of Fig. SG-4.2-1, illustration (d) when the union
process components shall conform to one of the material assembly is tightened to an amount recommended by
specifications listed in Part MM. the manufacturer. Gasket seal width as shown in
Fig. SG-4.2-1, illustration (d) shall be a maximum of
0.085 in. in the uncompressed condition prior to
DT-6 TESTS installation.
Hydrostatic testing of each fitting is not required in DT-9.3 Connections
this Standard; however, fittings shall be capable of with-
standing a hydrostatic test pressure of 1.5 times the Connections meeting all dimensions of Table DT-7-1
pressure rating shown in Table DT-2-1 at 100F (38C). are considered interchangeable. Alternative sealing
designs are acceptable, provided dimensions A, B, C,
and D of Table DT-7-1, as well as A and B of
(14) DT-7 TOLERANCES Table DT-9.3-1, are met. All connections shall be made
in accordance with SG-3.3.2.
Tables DT-3-1, DT-3-2, DT-4-1, and DT-7-1 list the
required tolerances for fittings and process components
DT-9.4 Hygienic Clamps
depicted by this Standard. For tubing tolerances, refer
to ASTM A270, Supplement 2. Table DT-7-2 lists the Hygienic clamps shall be designed and manufactured
required tolerances for transfer panel nozzles and through the entire range of all union component dimen-
jumpers. sional tolerances to accomplish the following:
These tolerances shall apply after heat and surface (a) completely retain all components in a fully sealed
treatment. state to meet the requirements of DT-2
The control portion of the fitting or process compo- (b) maintain proper component alignment during
nents (refer to C in the Table DT-3-1 illustration) is the installation and operation per SG-3.3.2.1
length from the welding end over which tolerances for (c) cause the ferrules to be aligned to meet a uniform
wall thickness and O.D. are maintained. The length of nominal gap per Fig. SG-2.2.2-1, illustration (d) when
the control portion is fixed for all sizes at 0.75 in. (19 mm). installed and tightened to the proper design
For exceptions, see Table DT-4.1.4-1 for ferrule lengths specifications
and Table DT-4.1.5-1 for automatic tube weld caps. (d) cause the gauging and contact diameter between
the ferrules and the mating surfaces of the clamp to occur
at the gauging diameter (A) specified in Table DT-9.3-1
DT-8 WELD ENDS
when installed and tightened to achieve the nominal
Where Type 316L is specified, the material of the auto- gap per Fig. SG-2.2.2-1, illustration (d).
matic weld end shall conform to the requirements for
NOTE: As this is a nominal design condition, manufacturing
chemical composition as prescribed in MM-5.1.1. For tolerances of the components will cause some variation in the
nonautomatic weld ends, the chemical composition shall actual gauging and contact diameter at assembly.
meet the requirements of the applicable ASTM
specification. (e) avoid any interference with any clamp union com-
Automatic weld ends furnished to this Standard shall ponents or itself that would prevent proper assembly
be furnished with square-cut ends, free from burrs and when assembled with all components (see Fig. DT-2-1)
breaks. All weld end connections for valves shall have
a minimum unobstructed weld end length equal to or
DT-10 MINIMUM EXAMINATION REQUIREMENTS
greater than the minimum control portion as per DT-7.
DT-10.1 Visual Inspection (14)

DT-9 HYGIENIC CLAMP UNIONS For fittings and process components including, but
not limited to, tubing, valves, pumps, filter housings,
(14) DT-9.1 Typical Hygienic Clamp Unions and instrumentation, each item shall be visually exam-
Typical hygienic clamp unions are described in ined for the following criteria, as a minimum. It is not a
SG-2.2.2. requirement that the packaged components be removed

91

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

from the original packaging, provided the following can Refer to Forms MEL-1 and MEL-2, which have been
be verified: provided as a guide for the Material Examination Log
(a) manufacturers name, logo, or trademark (see Nonmandatory Appendix B).
(b) alloy/material type
(c) description including size and configuration DT-11 MARKING
(d) heat number/code DT-11.1 Fitting Marking Information (14)
(e) process contact surface finish designation [only
Except as specified in DT-11.1.1, each fitting and pro-
one surface finish (SF) designation allowed]
cess component shall be permanently marked by any
(f) reference to ASME BPE
suitable method not injurious to the process contact sur-
(1) ASME BPE Certificate of Authorization holders face to show the following:
shall mark the reference to this Standard by applying (a) heat number/code traceable to material test report
their ASME Certification Mark with BPE Designator. for each process contact surface component
Refer to Fig. CR-1-1. (b) material type
(2) Non-ASME BPE Certificate of Authorization (c) manufacturers name, logo, or trademark
holders shall only mark BPE. (d) reference to this Standard (BPE)
(g) pressure rating for valves (1) ASME BPE Certificate of Authorization holders
(h) no damage or other noncompliances shall mark the reference to this Standard by applying
their ASME Mark with BPE Designator. Refer to
DT-10.2 Documentation Verification Fig. CR-1-1.
Refer to Part GR for documentation verification (2) Non-ASME BPE Certificate of Authorization
requirements. holders shall only mark BPE.
(e) process contact surface designation for the appro-
DT-10.3 Physical Examination priate BPE specification [only one surface finish (SF)
designation allowed]
For this paragraph, a lot shall be defined as a specific NOTE: All marking of a process component should be made
combination of size, configuration, and heat number outside of the control portion to optimize welding fit-up and identi-
for fittings and process components including, but not fication.
limited to, tubing, valves, pumps, filter housings, and
DT-11.1.1 Exceptions
instrumentation in a single shipment.
(a) Where the size of the fitting or process component
If required by the owner/user, a percentage of each
does not permit complete marking, the identification
lot may be physically examined by the manufacturer,
marks may be omitted in reverse of the order presented
installing contractor, inspection contractor, or owner/
above. However, the heat number and material type
user for the following criteria:
shall be marked on the fitting or process component.
(a) wall thickness (for weld ends only)
(b) Where the size of the fitting or process component
(b) outside diameter (O.D.) (for weld ends only) does not permit complete marking of the heat number,
(c) surface finish (as specified) a manufacturers code number is acceptable under this
(d) visual Standard.
When required examination reveals a defect(s), an
additional 10% of that lot shall be examined for the DT-11.2 Valve Marking Information (14)
specific defect(s). If this examination reveals another Except as specified in DT-11.2.1, each valve shall be
defect, an additional 10% of that lot shall be examined permanently marked by any suitable method not injuri-
for the specific defect(s). If additional defects are found, ous to the process contact surface to show the following:
perform 100% examination or reject the balance of the (a) heat number/code traceable to material test report
lot. All examined and accepted material in this lot may for all wetted metal component parts of the valve or
be retained and utilized valve fabrication, if more than one heat is used
The completed Material Examination Log shall (b) valve pressure rating
describe all of the features listed above. The results of (c) material type
the examination shall be recorded on a Material (d) manufacturers name, logo, or trademark
Examination Log. This documentation may be one line (e) reference to this Standard (BPE)
item for the total quantity of a particular size, configura- (1) ASME BPE Certificate of Authorization holders
tion, and heat number. The information required to be shall mark the reference to this Standard by applying
on the Material Examination Log may be in any format, their ASME Mark with BPE Designator. Refer to
written or tabular, to fit the needs of the manufacturer, Fig. CR-1-1.
installing contractor, inspection contractor, and owner/ (2) Non-ASME BPE Certificate of Authorization
user as long as all information is included or referenced. holders shall only mark BPE.

92

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(f) process contact surface designation for the appro- DT-11.3 Modified Surfaces (14)
priate BPE specification [only one surface finish (SF) When the surface finish of a process component is
designation allowed] modified, the surface finish designation marking shall
be changed to match the final surface finish designation
NOTE: All marking of a process component should be made according to Table SF-2.4-1. Only the final finish designa-
outside of the control portion to optimize welding fit-up and identi-
tion shall be indicated.
fication.
After removal of the original markings, all dimensions
and tolerances must comply with Tables DT-3-1 and, as
DT-11.2.1 Exceptions applicable, DT-3-2.
(a) Where the size of the valve does not permit com-
plete marking, the identification marks may be omitted DT-12 PACKAGING
in reverse of the order presented above. However, the All end connections of fittings or process components
heat number, valve pressure rating, and material type shall be protected with end caps. Additionally, fittings
shall be marked on the valve. shall be sealed in transparent bags or shrink wrapped.
(b) Where the size of the valve does not permit com- Additional packaging for process components, other
plete marking of the heat number, a manufacturers code than fittings, shall be as agreed to by the purchaser and
number is acceptable under this Standard. manufacturer.

93

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. DT-2-1 Clamp Conditions at Installation

Spacing should be
Acceptable maintained after Not Acceptable
torquing per
DT-9.4(e)

When clamp ends


are contacting,
the required load
is not imparted
onto the gasket
per DT-9.4(e)

Spacing should be
Acceptable maintained after Not Acceptable
torquing per
DT-9.4(e)

Acceptable Not Acceptable

Not Acceptable

94

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-2-1 Hygienic Unions: Rated Internal Working Pressure


Temperature < 3 in. Clamp 3 in. Clamp 4 in. Clamp 6 in. Clamp

F C psig kPa psig kPa psig kPa psig kPa

100 38 200 1 379 200 1 379 200 1 379 150 1 034


250 121 165 1 138 150 1 034 125 862 75 517

GENERAL NOTES:
(a) These pressure ratings apply to the hygienic clamp and gasket. For information on pressure ratings, see the manufacturers guidelines
for the components.
(b) For installation practices, refer to Fig. DT-2-1.

95

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Table DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components

B O P

C O
T

Squareness Equivalent Centerline


Face to Radius
Angle
Nominal O.D. Wall Thickness Tangent, B Off Angle, O Off Plane, P (CLR), R
(for O)
Size, in. in. mm in. mm in. mm in. mm deg in. mm in. mm
1
4 0.005 0.13 +0.003/0.004 +0.08/0.10 0.005 0.13 0.009 0.23 2.1 0.030 0.76 0.563 14.30
3
8 0.005 0.13 +0.003/0.004 +0.08/0.10 0.005 0.13 0.012 0.30 1.8 0.030 0.76 1.125 28.58
1
2 0.005 0.13 +0.005/0.008 +0.13/0.20 0.005 0.13 0.014 0.36 1.6 0.030 0.76 1.125 28.58
3
4 0.005 0.13 +0.005/0.008 +0.13/0.20 0.005 0.13 0.018 0.46 1.4 0.030 0.76 1.125 28.58
1 0.005 0.13 +0.005/0.008 +0.13/0.20 0.008 0.20 0.025 0.64 1.4 0.030 0.76 1.500 38.10
112 0.008 0.20 +0.005/0.008 +0.13/0.20 0.008 0.20 0.034 0.86 1.3 0.050 1.27 2.250 57.15
2 0.008 0.20 +0.005/0.008 +0.13/0.20 0.008 0.20 0.043 1.09 1.2 0.050 1.27 3.000 76.20
212 0.010 0.25 +0.005/0.008 +0.13/0.20 0.010 0.25 0.054 1.37 1.2 0.050 1.27 3.750 95.25
3 0.010 0.25 +0.005/0.008 +0.13/0.20 0.016 0.41 0.068 1.73 1.3 0.050 1.27 4.500 114.30
4 0.015 0.38 +0.008/0.010 +0.20/0.25 0.016 0.41 0.086 2.18 1.2 0.060 1.52 6.000 152.40
6 0.030 0.76 +0.015/0.015 +0.38/0.38 0.030 0.76 0.135 3.43 1.3 0.060 1.52 9.000 228.60

GENERAL NOTES:
(a) Tolerance on end-to-end and center-to-end dimension E is 0.050 in. (1.27 mm) for all fittings and process components depicted. For
those not depicted in this Standard, see manufacturer for standards.
(b) See Table DT-3-2 for electropolished wall thickness tolerances.
(c) See DT-7 (Tolerances) for C control portion lengths.
(d) See Table DT-4.1-1 for T tangent length dimensions.
(e) Tolerance for centerline radius (CLR) is 10% of the nominal dimension (R).

96

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-3-2 Final Tolerances for Electropolished


Fittings and Process Components
Wall Thickness
Nominal
Size, in. in. mm
1
4 +0.003/0.006 +0.08/0.15 Table DT-4.1-1 Tangent Lengths
3
8 +0.003/0.006 +0.08/0.15 Nominal Tangent, T
1
2 +0.005/0.010 +0.13/0.25 O.D. Tube
3
4 +0.005/0.010 +0.13/0.25 Size, in. in. mm
1
1 +0.005/0.010 +0.13/0.25 4 1.50 38.10
112 +0.005/0.010 +0.13/0.25 3
8 1.50 38.10
1
2 +0.005/0.010 +0.13/0.25 2 1.50 38.10
212 +0.005/0.010 +0.13/0.25 3
4 1.50 38.10
1 1.50 38.10
3 +0.005/0.010 +0.13/0.25 112 1.50 38.10
4 +0.008/0.012 +0.20/0.30 2 1.50 38.10
6 +0.015/0.017 +0.38/0.43 212 1.50 38.10
3 1.75 44.45
4 2.00 50.80
6 2.50 63.50
Table DT-4-1 Nominal O.D. Tubing Sizes
Tube Wall GENERAL NOTES:
Tube O.D. Thickness (a) Minimum tangent lengths for ferrules do not apply. See
Nominal Table DT-4.1.4-1, dimensions B and C, for available length
Size, in. in. mm in. mm options.
(b) Minimum tangent length for 14 in. to 34 in. size automatic
1
4 0.250 6.35 0.035 0.89 tube weld: 180 deg return bend does not conform (see
3
8 0.375 9.53 0.035 0.89 Table DT-4.1.1-7, Dimension B).
1
2 0.500 12.70 0.065 1.65 (c) Minimum tangent lengths for Tables DT-4.1.2-2, DT-4.1.2-3,
3
4 0.750 19.05 0.065 1.65 DT-4.1.2-7, DT-4.1.3-1, and DT-4.1.3-2 do not apply.
1 1.000 25.40 0.065 1.65
112 1.500 38.10 0.065 1.65
2 2.000 50.80 0.065 1.65
212 2.500 63.50 0.065 1.65
3 3.000 76.20 0.065 1.65
4 4.000 101.60 0.083 2.11
6 6.000 152.40 0.109 2.77

GENERAL NOTE: Refer to ASTM A270, Supplement 2 for tubing


tolerances.

97

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.1-2 Automatic Tube Weld: Hygienic


Clamp Joint, 90-deg Elbow

B
Table DT-4.1.1-1 Automatic Tube Weld: 90-deg
Elbow
A

A
A

Nominal Size, in. in. mm


1
4 2.625 66.7 A B
3
8 2.625 66.7 Nominal
1
2 3.000 76.2 Size, in. in. mm in. mm
3
4 3.000 76.2
1
4 2.625 66.7 1.625 41.3
3
1 3.000 76.2 8 2.625 66.7 1.625 41.3
1
112 3.750 95.3 2 3.000 76.2 1.625 41.3
3
2 4.750 120.7 4 3.000 76.2 1.625 41.3
212 5.500 139.7
1 3.000 76.2 2.000 50.8
3 6.250 158.8 112 3.750 95.3 2.750 69.9
4 8.000 203.2 2 4.750 120.7 3.500 88.9
6 11.500 292.1 212 5.500 139.7 4.250 108.0

3 6.250 158.8 5.000 127.0


4 8.000 203.2 6.625 168.3
6 11.500 292.1 10.500 266.7

98

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.1-3 Hygienic Clamp Joint: 90-deg Table DT-4.1.1-4 Automatic Tube Weld: 45-deg
Elbow Elbow
A

45 deg

A
A

A A

Nominal Size, in. in. mm Nominal Size, in. in. mm


1 1
4 1.625 41.3 4 2.000 50.8
3 3
8 1.625 41.3 8 2.000 50.8
1 1
2 1.625 41.3 2 2.250 57.2
3 3
4 1.625 41.3 4 2.250 57.2

1 2.000 50.8 1 2.250 57.2


112 2.750 69.9 112 2.500 63.5
2 3.500 88.9 2 3.000 76.2
212 4.250 108.0 212 3.375 85.7

3 5.000 127.0 3 3.625 92.1


4 6.625 168.3 4 4.500 114.3
6 10.500 266.7 6 6.250 158.8

99

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.1-5 Automatic Tube Weld: Hygienic Table DT-4.1.1-6 Hygienic Clamp Joint: 45-deg
Clamp Joint, 45-deg Elbow Elbow

A
B

45 deg
45 deg

Nominal Size, in. in. mm


1
4 1.000 25.4
3
8 1.000 25.4
1
2 1.000 25.4
3
4 1.000 25.4
A B
Nominal
Size, in. in. mm in. mm 1 1.125 28.6
112 1.438 36.5
1 2 1.750 44.5
4 2.000 50.8 1.000 25.4
3
8 2.000 50.8 1.000 25.4 212 2.063 52.4
1
2 2.250 57.2 1.000 25.4
3 3 2.375 60.3
4 2.250 57.2 1.000 25.4
4 3.125 79.4
1 2.250 57.2 1.125 28.6 6 5.250 133.4
112 2.500 63.5 1.438 36.5
2 3.000 76.2 1.750 44.5
212 3.375 85.7 2.063 52.4

3 3.625 92.1 2.375 60.3


4 4.500 114.3 3.125 79.4
6 6.250 158.8 5.250 133.4

100

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.1-7 Automatic Tube Weld: 180-deg Table DT-4.1.1-8 Hygienic Clamp Joint: 180-deg
Return Bend Return Bend
A A

B B

A B A B
Nominal Nominal
Size, in. in. mm in. mm Size, in. in. mm in. mm
1 1
4 4.500 114.3 2.625 66.7 4 4.500 114.3 3.125 79.4
3 3
8 4.500 114.3 2.625 66.7 8 4.500 114.3 3.125 79.4
1 1
2 4.500 114.3 3.000 76.2 2 4.500 114.3 3.500 88.9
3 3
4 4.500 114.3 3.000 76.2 4 4.500 114.3 3.500 88.9

1 3.000 76.2 3.000 76.2 1 3.000 76.2 3.500 88.9


112 4.500 114.3 4.500 114.3 112 4.500 114.3 5.000 127.0
2 6.000 152.4 5.000 127.0 2 6.000 152.4 5.500 139.7
212 7.500 190.5 5.750 146.1 212 7.500 190.5 6.250 158.8

3 9.000 228.6 6.500 165.1 3 9.000 228.6 7.000 177.8


4 12.000 304.8 8.500 215.9 4 12.000 304.8 9.125 231.8
6 18.000 457.2 11.500 292.1 6 18.000 457.2 13.000 330.2

1
GENERAL NOTE: 4 in.34 in. sizes do not conform to Table DT-4.1-1.

101

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.2-1 Automatic Tube Weld: Straight


Tee and Cross

Table DT-4.1.2-2 Automatic Tube Weld:


Short Outlet Hygienic Clamp Joint Tee
Y

A B
Nominal
Size, in. in. mm in. mm
1
4 1.750 44.5 1.000 25.4
3
8 1.750 44.5 1.000 25.4
1
2 1.875 47.6 1.000 25.4
3
4 2.000 50.8 1.125 28.6

1 2.125 54.0 1.125 28.6


112 2.375 60.3 1.375 34.9
A
2 2.875 73.0 1.625 41.3
212 3.125 79.4 1.875 47.6
A
3 3.375 85.7 2.125 54.0
Nominal Size, in. in. mm 4 4.125 104.8 2.750 69.9
6 5.625 142.9 4.625 117.5
1
4 1.750 44.5
3
8 1.750 44.5
1
2 1.875 47.6
3
4 2.000 50.8

1 2.125 54.0
112 2.375 60.3
2 2.875 73.0
212 3.125 79.4

3 3.375 85.7
4 4.125 104.8
6 5.625 142.9

102

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.2-4 Hygienic Clamp Joint: Straight


Tee and Cross

Table DT-4.1.2-3 Hygienic Mechanical Joint: Short


Outlet Run Tee

B A

A B C
Nominal
Size, in. in. mm in. mm in. mm
1
4 0.875 22.2 1.750 44.5 1.750 44.5
3 A
8 0.875 22.2 1.750 44.5 1.750 44.5
1
2 0.875 22.2 1.875 47.6 1.875 47.6
3 A
4 1.000 25.4 2.000 50.8 2.000 50.8

1 1.125 28.6 2.125 54.0 2.125 54.0 Nominal Size, in. in. mm
112 1.375 34.9 2.375 60.3 2.375 60.3 1
4 2.250 57.2
2 1.625 41.3 2.875 73.0 2.875 73.0 3
8 2.250 57.2
212 1.875 47.6 3.125 79.4 3.125 79.4 1
2 2.250 57.2
3
4 2.375 60.3
3 2.125 54.0 3.375 85.7 3.375 85.7
4 2.750 69.9 4.125 104.8 4.125 104.8 1 2.625 66.7
6 4.625 117.5 5.625 142.9 5.625 142.9 112 2.875 73.0
2 3.375 85.7
212 3.625 92.1

3 3.875 98.4
4 4.750 120.7
6 7.125 181.0

103

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.2-6 Automatic Tube Weld:


Reducing Tee
Y

Nominal Size,
in. A B
Table DT-4.1.2-5 Hygienic Clamp Joint:
X Y in. mm in. mm
Short Outlet Tee
3 1
8 4 1.750 44.5 1.750 44.5
1 1
2 4 1.875 47.6 1.875 47.6
1 3
2 8 1.875 47.6 1.875 47.6
B 3 1
4 4 2.000 50.8 2.000 50.8
3 3
4 8 2.000 50.8 2.000 50.8
3 1
4 2 2.000 50.8 2.000 50.8
1
1 4 2.125 54.0 2.125 54.0
3
1 8 2.125 54.0 2.125 54.0
1
1 2 2.125 54.0 2.125 54.0
A 1 3
4 2.125 54.0 2.125 54.0
112 1
2 2.375 60.3 2.375 60.3
A B 112 3
4 2.375 60.3 2.375 60.3
Nominal
Size, in. in. mm in. mm 112 1 2.375 60.3 2.375 60.3
1
2 2 2.875 73.0 2.625 66.7
1
2 2.250 57.2 1.000 25.4 2 3
4 2.875 73.0 2.625 66.7
3
4 2.375 60.3 1.125 28.6 2 1 2.875 73.0 2.625 66.7
1 2.625 66.7 1.125 28.6 2 112 2.875 73.0 2.625 66.7
112 2.875 73.0 1.375 34.9 212 1
2 3.125 79.4 2.875 73.0
2 3.375 85.7 1.625 41.3
212 3.625 92.1 1.875 47.6 212 3
4 3.125 79.4 2.875 73.0
3 3.875 98.4 2.125 54.0 212 1 3.125 79.4 2.875 73.0
4 4.750 120.7 2.750 69.9 212 112 3.125 79.4 2.875 73.0
6 7.125 181.0 4.625 117.5 212 2 3.125 79.4 2.875 73.0
1
3 2 3.375 85.7 3.125 79.4
3
3 4 3.375 85.7 3.125 79.4
3 1 3.375 85.7 3.125 79.4
3 112 3.375 85.7 3.125 79.4
3 2 3.375 85.7 3.125 79.4
3 212 3.375 85.7 3.125 79.4
1
4 2 4.125 104.8 3.625 92.1
3
4 4 4.125 104.8 3.625 92.1
4 1 4.125 104.8 3.625 92.1
4 112 4.125 104.8 3.625 92.1
4 2 4.125 104.8 3.875 98.4
4 212 4.125 104.8 3.875 98.4
4 3 4.125 104.8 3.875 98.4

6 3 5.625 142.9 4.875 123.8


6 4 5.625 142.9 5.125 130.2

104

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.2-7 Automatic Tube Weld: Short


Outlet Hygienic Clamp, Joint Reducing Tee
Y

Nominal Size,
in. A B
X Y in. mm in. mm
3 1
8 4 1.750 44.5 1.000 25.4
1 1
2 4 1.875 47.6 1.000 25.4
1 3
2 8 1.875 47.6 1.000 25.4
3 1
4 4 2.000 50.8 1.000 25.4
3 3
4 8 2.000 50.8 1.000 25.4
3 1
4 2 2.000 50.8 1.000 25.4
1
1 4 2.125 54.0 1.125 28.6
3
1 8 2.125 54.0 1.125 28.6
1
1 2 2.125 54.0 1.125 28.6
3
1 4 2.125 54.0 1.125 28.6
112 1
2 2.375 60.3 1.375 34.9
112 3
4 2.375 60.3 1.375 34.9
112 1 2.375 60.3 1.375 34.9
1
2 2 2.875 73.0 1.625 41.3
3
2 4 2.875 73.0 1.625 41.3
2 1 2.875 73.0 1.625 41.3
2 112 2.875 73.0 1.625 41.3
212 1
2 3.125 79.4 1.875 47.6
212 3
4 3.125 79.4 1.875 47.6
212 1 3.125 79.4 1.875 47.6
212 112 3.125 79.4 1.875 47.6
212 2 3.125 79.4 1.875 47.6
1
3 2 3.375 85.7 2.125 54.0
3
3 4 3.375 85.7 2.125 54.0
3 1 3.375 85.7 2.125 54.0
3 112 3.375 85.7 2.125 54.0
3 2 3.375 85.7 2.125 54.0
3 212 3.375 85.7 2.125 54.0
1
4 2 4.125 104.8 2.625 66.7
3
4 4 4.125 104.8 2.625 66.7
4 1 4.125 104.8 2.625 66.7
4 112 4.125 104.8 2.625 66.7
4 2 4.125 104.8 2.625 66.7
4 212 4.125 104.8 2.625 66.7
4 3 4.125 104.8 2.625 66.7
1
6 2 5.625 142.9 3.625 92.1
3
6 4 5.625 142.9 3.625 92.1
6 1 5.625 142.9 3.625 92.1
6 112 5.625 142.9 3.625 92.1
6 2 5.625 142.9 3.625 92.1
6 212 5.625 142.9 3.625 92.1
6 3 5.625 142.9 3.625 92.1
6 4 5.625 142.9 3.750 95.3

105

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.2-8 Hygienic Clamp Joint: Reducing


Tee
Y

Nominal Size,
in. A B

X Y in. mm in. mm
3 1
8 4 2.250 57.2 2.250 57.2
1 1
2 4 2.375 60.3 2.375 60.3
1 3
2 8 2.375 60.3 2.375 60.3
3 1
4 4 2.500 63.5 2.500 63.5
3 3
4 8 2.500 63.5 2.500 63.5
3 1
4 2 2.500 63.5 2.500 63.5
1
1 4 2.625 66.7 2.625 66.7
3
1 8 2.625 66.7 2.625 66.7
1
1 2 2.625 66.7 2.625 66.7
3
1 4 2.625 66.7 2.625 66.7
112 1
2 2.875 73.0 2.875 73.0
112 3
4 2.875 73.0 2.875 73.0
112 1 2.875 73.0 2.875 73.0
1
2 2 3.375 85.7 3.125 79.4
3
2 4 3.375 85.7 3.125 79.4
2 1 3.375 85.7 3.125 79.4
2 112 3.375 85.7 3.125 79.4
212 1
2 3.625 92.1 3.375 85.7
212 3
4 3.625 92.1 3.375 85.7
212 1 3.625 92.1 3.375 85.7
212 1
1 2 3.625 92.1 3.375 85.7
212 2 3.625 92.1 3.375 85.7
1
3 2 3.875 98.4 3.625 92.1
3
3 4 3.875 98.4 3.625 92.1
3 1 3.875 98.4 3.625 92.1
3 112 3.875 98.4 3.625 92.1
3 2 3.875 98.4 3.625 92.1
3 212 3.875 98.4 3.625 92.1
1
4 2 4.750 120.7 4.125 104.8
3
4 4 4.750 120.7 4.125 104.8
4 1 4.750 120.7 4.125 104.8
4 112 4.750 120.7 4.125 104.8
4 2 4.750 120.7 4.375 111.1
4 212 4.750 120.7 4.375 111.1
4 3 4.750 120.7 4.375 111.1
6 3 7.125 181.0 5.375 136.5
6 4 7.125 181.0 5.750 146.1

106

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.2-9 Hygienic Clamp Joint: Short Table DT-4.1.2-10 Automatic Tube Weld:
Outlet Reducing Tee Instrument Tee
Y
Y

B
B
X
X

A
A

Nominal Size,
Nominal Size, in. A B
in. A B
X Y in. mm in. mm
X Y in. mm in. mm
3
8 1
4 2.250 57.2 1.000 25.4
1
2 112 2.500 63.5 0.875 22.2
1
2 1
4 2.375 60.3 1.000 25.4
3
4 112 2.500 63.5 1.000 25.4
1
2 3
8 2.375 60.3 1.000 25.4 1 112 2.500 63.5 1.125 28.6
3
4 1
4 2.500 63.5 1.000 25.4
1
2 2 2.750 69.9 1.000 25.4
3
4 3
8 2.500 63.5 1.000 25.4
3
4 2 2.750 69.9 1.125 28.6
3
4 1
2 2.500 63.5 1.000 25.4 1 2 2.750 69.9 1.250 31.8
1 1
4 2.625 66.7 1.125 28.6 112 2 2.750 69.9 1.500 38.1
3
1 8 2.625 66.7 1.125 28.6
1
1 2 2.625 66.7 1.125 28.6
3
1 4 2.625 66.7 1.125 28.6
112 1
2 2.875 73.0 1.375 34.9
112 3
4 2.875 73.0 1.375 34.9
112 1 2.875 73.0 1.375 34.9
1
2 2 3.375 85.7 1.625 41.3 Table DT-4.1.2-11 Hygienic Clamp Joint:
3
2 4 3.375 85.7 1.625 41.3 Instrument Tee
2 1 3.375 85.7 1.625 41.3
2 112 3.375 85.7 1.625 41.3 Y
212 1
2 3.625 92.1 1.875 47.6
212 3
4 3.625 92.1 1.875 47.6
212 1 3.625 92.1 1.875 47.6 B
212 112 3.625 92.1 1.875 47.6
212 2 3.625 92.1 1.875 47.6 X
1
3 2 3.875 98.4 2.125 54.0
3
3 4 3.875 98.4 2.125 54.0
3 1 3.875 98.4 2.125 54.0
3 112 3.875 98.4 2.125 54.0
A
3 2 3.875 98.4 2.125 54.0
3 212 3.875 98.4 2.125 54.0
1
4 2 4.750 120.7 2.625 66.7 Nominal Size,
3
4 4 4.750 120.7 2.625 66.7 in. A B
4 1 4.750 120.7 2.625 66.7
X Y in. mm in. mm
4 112 4.750 120.7 2.625 66.7
4 2 4.750 120.7 2.625 66.7 1
2 112 3.000 76.2 0.875 22.2
4 212 4.750 120.7 2.625 66.7 3
4 112 3.000 76.2 1.000 25.4
4 3 4.750 120.7 2.625 66.7
1 1 112 3.000 76.2 1.125 28.6
6 2 7.125 181.0 3.625 92.1 1
2 2 3.250 82.6 1.000 25.4
3
6 4 7.125 181.0 3.625 92.1 3
4 2 3.250 82.6 1.125 28.6
6 1 7.125 181.0 3.625 92.1 1 2 3.250 82.6 1.250 31.8
6 112 7.125 181.0 3.625 92.1 112 2 3.250 82.6 1.500 38.1
6 2 7.125 181.0 3.625 92.1
6 212 7.125 181.0 3.625 92.1
6 3 7.125 181.0 3.625 92.1
6 4 7.125 181.0 3.750 95.3

107

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Table DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer
L4
L4 R1 R2

L3
L1 L1
L3
L2
X Y X

L2
 Y

R1

R2
A A

Minimum Minimum Minimum Minimum


Nominal I.D Tangent, I.D. Tangent, O.D. Tangent, O.D. Tangent, Maximum Minimum Minimum
Size, in. Overall Length, Large End, Small End, Small End, Large End, Internal Taper, Internal Radius, External Radius,
X Y A, in. L1, in. L2, in. L3, in. L4, in. , deg R1, in. R2, in.
3 1
8 4 1.625 0.375 0.875 0.750 0.750 30 0.250 0.031
1 1
2 4 1.875 0.375 0.875 0.750 1.000 30 0.250 0.031
1 3
2 8 1.875 0.375 0.875 0.750 1.000 30 0.250 0.031
3 3
4 8 2.000 0.375 0.875 0.750 1.000 30 0.250 0.031
3 1
4 2 2.125 0.375 1.125 1.000 1.000 30 0.250 0.031
1
1 2 2.500 0.375 1.125 1.000 1.000 30 0.250 0.031
3
1 4 2.125 0.375 1.125 1.000 1.000 30 0.250 0.031

112 3
4 3.000 0.375 1.125 1.000 1.000 30 0.250 0.031
112 1 2.500 0.375 1.125 1.000 1.000 30 0.250 0.031
2 1 3.375 0.375 1.125 1.000 1.000 30 0.250 0.031
2 112 2.500 0.375 1.125 1.000 1.000 30 0.250 0.031
212 112 3.375 0.375 1.125 1.000 1.000 30 0.250 0.031
212 2 2.500 0.375 1.125 1.000 1.000 30 0.250 0.031
3 112 4.250 0.375 1.125 1.000 1.500 30 0.250 0.031
3 2 3.375 0.375 1.125 1.000 1.500 30 0.250 0.031
3 212 2.625 0.375 1.125 1.000 1.500 30 0.250 0.031
4 2 5.125 0.375 1.125 1.000 1.500 30 0.250 0.031
4 212 4.250 0.375 1.125 1.000 1.500 30 0.250 0.031
4 3 3.875 0.375 1.625 1.500 1.500 30 0.250 0.031
6 3 7.250 0.375 1.625 1.500 2.000 30 0.250 0.031
6 4 5.625 0.375 1.625 1.500 2.000 30 0.250 0.031

108

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer (14)

R1 R2

L3
L1 L1
L3
L2
X Y X 
L2
 Y

R1
R2
A A

Minimum Minimum Minimum


Nominal I.D Tangent, I.D. Tangent, O.D. Tangent, Maximum Minimum Minimum
Size, in. Overall Length, Large End, Small End, Small End, Internal Taper, Internal Radius, External Radius,
X Y A, in. L1, in. L2, in. L3, in. , deg R1, in. R2, in.
3 1
8 4 2.125 0.375 0.875 0.750 30 0.250 0.031
1 1
2 4 2.375 0.375 0.875 0.750 30 0.250 0.031
1 3
2 8 2.375 0.375 0.875 0.750 30 0.250 0.031
3 3
4 8 2.500 0.375 0.875 0.750 30 0.250 0.031
3 1
4 2 2.625 0.375 1.125 1.000 30 0.250 0.031
1
1 2 3.000 0.375 1.125 1.000 30 0.250 0.031
3
1 4 2.625 0.375 1.125 1.000 30 0.250 0.031

112 3
4 3.500 0.375 1.125 1.000 30 0.250 0.031
112 1 3.000 0.375 1.125 1.000 30 0.250 0.031
2 1 3.875 0.375 1.125 1.000 30 0.250 0.031
2 112 3.000 0.375 1.125 1.000 30 0.250 0.031
212 112 3.875 0.375 1.125 1.000 30 0.250 0.031
212 2 3.000 0.375 1.125 1.000 30 0.250 0.031
3 112 4.750 0.375 1.125 1.000 30 0.250 0.031
3 2 3.875 0.375 1.125 1.000 30 0.250 0.031
3 212 3.125 0.375 1.125 1.000 30 0.250 0.031
4 2 5.750 0.375 1.125 1.000 30 0.250 0.031
4 212 4.875 0.375 1.125 1.000 30 0.250 0.031
4 3 4.500 0.375 1.625 1.500 30 0.250 0.031
6 3 8.000 0.375 1.625 1.500 30 0.250 0.031
6 4 6.375 0.375 1.625 1.500 30 0.250 0.031

109

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Table DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer

R1 R2

L1
L1

L2
X
X Y
L2
Y

R1

R2
A A

Minimum Minimum
Nominal Size, I.D Tangent, I.D. Tangent, Maximum Minimum Minimum
in. Overall Length, Large End, Small End, Internal Taper, Internal Radius, External Radius,
X Y A, in. L1, in. L2, in. , deg R1, in. R2, in.
3 1
8 4 2.625 0.375 0.875 30 0.250 0.031
1 1
2 4 2.875 0.375 0.875 30 0.250 0.031
1 3
2 8 2.875 0.375 0.875 30 0.250 0.031
3 3
4 8 3.000 0.375 0.875 30 0.250 0.031
3 1
4 2 3.125 0.375 1.125 30 0.250 0.031
1
1 2 3.500 0.375 1.125 30 0.250 0.031
3
1 4 3.125 0.375 1.125 30 0.250 0.031

112 3
4 4.000 0.375 1.125 30 0.250 0.031
112 1 3.500 0.375 1.125 30 0.250 0.031
2 1 4.375 0.375 1.125 30 0.250 0.031
2 112 3.500 0.375 1.125 30 0.250 0.031
212 112 4.375 0.375 1.125 30 0.250 0.031
212 2 3.500 0.375 1.125 30 0.250 0.031
3 112 5.250 0.375 1.125 30 0.250 0.031
3 2 4.375 0.375 1.125 30 0.250 0.031
3 212 3.625 0.375 1.125 30 0.250 0.031
4 2 6.250 0.375 1.125 30 0.250 0.031
4 212 5.375 0.375 1.125 30 0.250 0.031
4 3 5.000 0.375 1.625 30 0.250 0.031
6 3 8.500 0.375 1.625 30 0.250 0.031
6 4 7.000 0.375 1.625 30 0.250 0.031

110

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.4-1 Automatic Tube Weld: Ferrule

A, B, C

Nominal A B C
Size, in. in. mm in. mm in. mm
1
4 1.750 44.5 1.130 28.7 0.500 12.7
3
8 1.750 44.5 1.130 28.7 0.500 12.7
1
2 1.750 44.5 1.130 28.7 0.500 12.7
3
4 1.750 44.5 1.130 28.7 0.500 12.7

1 1.750 44.5 1.130 28.7 0.500 12.7


112 1.750 44.5 1.130 28.7 0.500 12.7
2 2.250 57.2 1.130 28.7 0.500 12.7
212 2.250 57.2 1.130 28.7 0.500 12.7

3 2.250 57.2 1.130 28.7 0.500 12.7


4 2.250 57.2 1.130 28.7 0.625 15.9
6 3.000 76.2 1.500 38.1 0.750 19.1

111

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.1.5-1 Automatic Tube Weld: Cap


A

A, Min.

Nominal Size, in. in. mm


1
2 1.500 38.1
3
4 1.500 38.1
1 1.500 38.1
112 1.500 38.1
2 1.500 38.1
212 1.500 38.1
3 1.750 44.5
4 2.000 50.8
6 2.500 63.5

GENERAL NOTE: Minimum I.D. control portion length, B, is 0.375 in.


(9.53 mm) for all sizes.

(14) Table DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap

A, min.
Nominal Size, in. Type in. mm
1
4 A 0.187 4.7
3
8 A 0.187 4.7
1
2 A 0.187 4.7
3
4 A 0.187 4.7
1 A 0.250 6.4

1 B 0.250 6.4
112 B 0.250 6.4
2 B 0.250 6.4
212 B 0.250 6.4
3 B 0.250 6.4
4 B 0.312 7.9
6 B 0.437 11.1

112

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-4.4.1-1 Hygienic Clamp Joint: Weir Style


Diaphragm Valve

A
Nominal Size,
in. in. mm
1
4 Fractional 2.500 63.5
3
8 Fractional 2.500 63.5
1
2 Fractional 2.500 63.5
1
2 3.500 88.9
3
4 4.000 101.6

1 4.500 114.3
112 5.500 139.7
2 6.250 158.8
212 7.630 193.8

3 8.750 222.3
4 11.500 292.1

113

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
(14) Table DT-7-1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances
Type A

Groove E
detail
G

R1
G
R2
D F B A
R4
R3
A1

Groove Detail C

114
Flange
Tube Diameter, I.D. Bore, Flange Angle, Flange Diameter, Thickness, Groove Diameter,
A, in. B, in. C, deg D, in. E, in. ref. F, in.
ASME BPE-2014

Nominal Dimen- Tolerance, Dimen- Tolerance, Dimen- Tolerance, Dimen- Tolerance, Tolerance, Dimen- Dimen- Tolerance, Tolerance,
Size, in. Type sion sion sion sion + sion sion +
1
4 A 0.250 0.005 0.180 0.005 20 0.5 0.984 0.005 0.005 0.143 0.800 0.005 0.005
3
8 A 0.375 0.005 0.305 0.005 20 0.5 0.984 0.005 0.005 0.143 0.800 0.005 0.005
1
2 A 0.500 0.005 0.370 0.005 20 0.5 0.984 0.005 0.005 0.143 0.800 0.005 0.005
3
4 A 0.750 0.005 0.620 0.005 20 0.5 0.984 0.005 0.005 0.143 0.800 0.005 0.005
1 A 1.000 0.005 0.870 0.005 20 1.0 1.339 0.005 0.005 0.143 1.160 0.005 0.005

Copyright c 2014 by the American Society of Mechanical Engineers.


Groove Depth, G, in. Face Offset, H, in. Groove Detail, R3, in. Groove Detail, R4, in. Groove Detail, A1, deg Radius, Radius,
R1, in. R2, in.

No reproduction may be made of this material without written consent of ASME.


Nominal Dimen- Tolerance, Dimen- Tolerance, Dimen- Tolerance, Dimen- Tolerance, Dimen- Tolerance,
Size, in. Type sion sion sion sion sion Max. Max. Min.
1
4 A 0.085 0.005 0.031 0.005 0.031 0.005 0.020 0.005 35 1 0.031 0.031 0.005
3
8 A 0.085 0.005 0.031 0.005 0.031 0.005 0.020 0.005 35 1 0.031 0.031 0.005
1
2 A 0.085 0.005 0.031 0.005 0.031 0.005 0.020 0.005 35 1 0.031 0.031 0.005
3
4 A 0.085 0.005 0.031 0.005 0.031 0.005 0.020 0.005 35 1 0.031 0.031 0.005
1 A 0.085 0.005 0.031 0.005 0.031 0.005 0.020 0.005 35 1 0.031 0.031 0.005
Table DT-7-1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances (Contd)
Type B
E
Groove
detail G

R1

R4 R2
A1
R3
D F B A

G
Groove Detail

Flange
Tube Diameter, I.D. Bore, Flange Angle, Flange Diameter, Thickness, Groove Diameter,
A, in. B, in. C, deg D, in. E, in. ref. F, in.

115
Nominal Dimen- Tolerance, Dimen- Tolerance, Dimen- Tolerance, Dimen- Tolerance, Tolerance, Dimen- Dimen- Tolerance, Tolerance,
Size, in. Type sion sion sion sion + sion sion +
ASME BPE-2014

1 B 1.000 0.005 0.870 0.005 20 1.0 1.984 0.008 0.005 0.112 1.718 0.005 0.005
112 B 1.500 0.008 1.370 0.005 20 1.0 1.984 0.008 0.005 0.112 1.718 0.005 0.005
2 B 2.000 0.008 1.870 0.005 20 1.0 2.516 0.008 0.008 0.112 2.218 0.005 0.005
212 B 2.500 0.010 2.370 0.005 20 1.0 3.047 0.008 0.008 0.112 2.781 0.005 0.005
3 B 3.000 0.010 2.870 0.005 20 1.0 3.579 0.010 0.010 0.112 3.281 0.005 0.005
4 B 4.000 0.015 3.834 0.005 20 1.0 4.682 0.015 0.015 0.112 4.344 0.005 0.005
6 B 6.000 0.030 5.782 0.005 20 1.0 6.570 0.030 0.030 0.220 6.176 0.005 0.005

Copyright c 2014 by the American Society of Mechanical Engineers.


Groove Depth, G, in. Face Offset, H, in. Groove Detail, R3, in. Groove Detail, R4, in. Groove Detail, A1, deg Radius, Radius,

No reproduction may be made of this material without written consent of ASME.


R1, in. R2, in.
Nominal Dimen- Tolerance, Dimen- Tolerance, Dimen- Tolerance, Dimen- Tolerance, Dimen- Tolerance,
Size, in. Type sion sion sion sion sion Max. Max. Min.
1 B 0.063 0.005 N/A N/A 0.047 0.005 0.020 0.005 46 1 0.063 0.031 0.005
112 B 0.063 0.005 N/A N/A 0.047 0.005 0.020 0.005 46 1 0.063 0.031 0.005
2 B 0.063 0.005 N/A N/A 0.047 0.005 0.020 0.005 46 1 0.063 0.031 0.005
212 B 0.063 0.005 N/A N/A 0.047 0.005 0.020 0.005 46 1 0.063 0.031 0.005
3 B 0.063 0.005 N/A N/A 0.047 0.005 0.020 0.005 46 1 0.063 0.031 0.005
4 B 0.063 0.005 N/A N/A 0.047 0.005 0.020 0.005 46 1 0.063 0.031 0.005
6 B 0.063 0.005 N/A N/A 0.047 0.005 0.020 0.005 46 1 0.063 0.031 0.005

GENERAL NOTES:
(a) Dimensions and tolerances apply to machined finishes only.
(b) I.D. bore dimension B should be measured on the ferrule face side only.
ASME BPE-2014

Table DT-7-2 Transfer Panel and Jumper Tolerances


Flatness Tolerance
Connection Nominal Maximum Gap Center-to-Center
Size, in. Allowed, in. Dimensional Tolerance, in.
0.50 0.010 0.015
0.75 0.010 0.015
1.00 0.020 0.015
1.50 0.020 0.015
2.00 0.025 0.015
2.50 0.025 0.015
3.00 0.030 0.015
4.00 0.040 0.015

116

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria (14)

Nominal design
clamp to ferrule
contact point per
DT-9.4(d)
B, gauging width Clearance
per DT-9.4(e)

Clearance
per DT-9.4(e)

A, gauging diameter
0.065 in.
per DT-9.4(c)

Basic Gauging and


Contact Diameter, Gauging Width,
Nominal Type A, in. ref B, in. Hygienic Clamp
Size, in. (From Table DT-7-1) Dimension Dimension Tolerance, Size, in.
1 3
4 A 0.867 0.164 0.004 4
3 3
8 A 0.867 0.164 0.004 4
1 3
2 A 0.867 0.164 0.004 4
3 3
4 A 0.867 0.164 0.004 4
1 A 1.222 0.164 0.004 ISO DN15

1 B 1.748 0.155 0.005 112


112 B 1.748 0.155 0.005 112
2 B 2.280 0.155 0.005 2
212 B 2.811 0.155 0.005 212
3 B 3.264 0.169 0.005 3
4 B 4.288 0.184 0.005 4
6 B 6.255 0.277 0.005 6

117

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Part MJ
Materials Joining

MJ-1 PURPOSE AND SCOPE MJ-2.1.4 Other Metals. Other metals (e.g., titanium,
tantalum, palladium, or gold, as used in instrumenta-
The purpose of this Part is to provide requirements
tion) may be joined, when specified by the owner/user.
for the joining of metallic and polymeric materials. This
includes joining methods, welding procedure and per-
MJ-2.2 Filler Metals
formance qualifications, examination, inspection, test-
ing, and acceptance criteria. MJ-2.2.1 Stainless Steels. When filler metals are
used, the matching filler metals listed in
Table MM-5.1.2-1 and Table MM-5.1.2-2 shall be used
MJ-2 MATERIALS
except that higher alloy filler metals may be used when
MJ-2.1 Base Metals specified by the owner/user.
Austenitic stainless steel grades may be welded with
MJ-2.1.1 Stainless Steels
or without filler metals.
(a) Austenitic Stainless Steels. Only the austenitic
Superaustenitic stainless steels shall be welded either
stainless steel grades listed in Table MM-2.1-1 or
with or without filler metals or consumable inserts.
Table MM-2.1-3 may be used for welded components,
When welded autogenously (without filler metal or con-
except as permitted in MM-5.1.
sumable inserts), postweld solution heat treatment in
Weld ends that are to be autogenously welded (with-
accordance with the manufacturers recommendations
out filler metal or consumable inserts) shall meet the
is required to minimize segregation.
requirements of MM-5.1.1.
Duplex stainless steels shall be welded either with
However, a process component or tube of one of the
or without filler metals or consumable inserts. When
above alloys with a sulfur content either below the lower
welded autogenously, postweld solution heat treatment
limit or above the upper limit for sulfur in MM-5.1.1
in accordance with the manufacturers recommenda-
may be used in a welded connection, provided that all
tions is required. Welding of duplex stainless steels gen-
of the following conditions are met:
erally results in an increase in the amount of ferrite in
(1) Use of the process component or tube is agreed
the microstructure, and as a result, appropriate welding
to by the owner/user.
procedures should be selected. The balance of austenite
(2) All welds on the component or tube are inter- and ferrite in the weld metal shall be maintained so that
nally inspected and meet the requirements of MJ-8.4. there is no less than 30% of the lesser phase.
(b) Superaustenitic Stainless Steels. Only the super-
austenitic stainless steel grades listed in Table MM-2.1-1 MJ-2.2.2 Nickel Alloys. When filler metals are used,
or Table MM-2.1-3 may be used for welded components, the matching filler metals listed in Table MM-5.1.2-1 and
except as permitted in MM-5.1. Table MM-5.1.2-2 shall be used, except that higher alloy
The superaustenitic stainless steels are prone to the filler metals may be used when specified by the
precipitation of undesirable secondary intermetallic owner/user.
phases such as sigma and chi. The cautions of MM-5.2.2 Nickel alloys shall be welded with or without filler
must be considered when welding superaustenitic stain- metals. Postweld solution heat treatment is not required.
less steels.
(c) Duplex Stainless Steels. Only the duplex stainless MJ-2.2.3 Copper Alloys. Brazing joint filler materials
steel grades listed in Table MM-2.1-1 or Table MM-2.1-3 shall comply with ANSI/AWS A5.8. Copper-to-copper
may be used for welded components, except as permit- joints shall be brazed using copper-phosphorus or cop-
ted in MM-5.1. The cautions of MM-5.2.4 must be consid- per-phosphorus-silver brazing filler metal (BCuP series)
ered when welding duplex stainless steels. without flux.

MJ-2.1.2 Nickel Alloys. Only the nickel alloys listed MJ-2.3 Nonmetallics
in Table MM-2.1-2 or Table MM-2.1-3 may be used for
Joining of polymers shall be performed in accordance
welded components, except as permitted in MM-5.1.
with MJ-9. Joining of other nonmetallic materials shall
MJ-2.1.3 Copper Alloys. Only the copper alloys be in accordance with procedures and processes recom-
listed in Table MM-2.1-4 may be used for brazed systems. mended by the material manufacturer, and approved

118

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

by the owner/user, using materials or compounds that surfaces prior to welding. Welding on tubing shall be
are inert to the intended service. done using automatic (or machine) welding techniques
(such as orbital tube welding or lathe welding), except
where size or space will not permit. In that case, manual
MJ-3 JOINT DESIGN AND PREPARATION welding can be performed, but must be agreed to by
MJ-3.1 General the owner/user and contractor.
All butt joints in which one or both weld faces is a MJ-3.5 Tube-Attachment Welds
process contact surface shall have continuous complete
weld joint penetration. This requirement exists for welds (a) Tube-attachment welds, as addressed in this
made from either one side or from both sides of the Standard, are those that
weld joint. All weld joints must have the process contact (1) make branch connections other than those used
surfaces properly purged or protected for the prevention to fabricate the fittings described in Part DT of this
of discoloration or contamination. External attachments Standard
(e.g., lift lugs, dimple jackets, ladder clips, etc.) must (2) attach tubes to other product forms
have any discoloration of the process contact surface (3) attach nozzles to transfer panels
removed. (4) attach a tube to any part of a hygienic system
Welds attaching any connection that passes through (b) Tube-attachment welds not governed by this Part
the wall of a tank or vessel, or a branch connection on of the Standard include
a pipe or tube system, in which one or both sides of the (1) those governed by MJ-8.4 of this Standard
weld joint is a process contact surface, shall either be (2) tube-to-tubesheet welds that are governed by
joined with a full penetration groove weld with a rein- ASME BPVC, Section VIII, in addition to the visual
forcing fillet weld [similar to Fig. SD-3.4.2-2, illustration inspection requirements of Part SF and MJ-8.2 of this
(a)], or have at least one telltale hole provided if double Standard
fillet welded only [similar to Fig. SD-3.4.2-2, illustration These welds may be performed by the manual,
(b)]. A telltale hole is required on all lap, tee, corner, or machine, or an automatic welding process. Joint designs
edge joints that have one or both welds as a process shall comply with MJ-3.1. The weld joints for complete
contact surface and are not attached by full penetration penetration welds shall be prepared by means compati-
welds. The telltale hole shall provide a path for product ble with hygienic service. The weld joints shall be prop-
or test media flow if the inner weld containment fails. erly cleaned within 12 in. (13 mm) on the inside and
Telltale holes are not required when all welds are on outside surfaces, where accessible, prior to welding.
process contact surfaces [e.g., Fig. SD-3.4.3-1, illustration Either fillet welds, groove welds, or a combination of
(c) detail or similar]. The telltale hole shall be no larger both may be used.
than NPS 14 in. (6 mm) and may be tapped for a prelimi-
nary compressed air and soapsuds test for tightness of MJ-3.6 Brazed Joints
inside welds. These telltale holes may be plugged when Joint design shall comply with the latest edition of
the vessel is in service. The plugging material used shall NFPA 99.
not be capable of sustaining pressure between the lapped
surfaces.
MJ-4 JOINING PROCESSES AND PROCEDURES
Socket welding is not permitted in process stream
systems or where CIP or SIP requirements are defined. MJ-4.1 Welds Finished After Welding
For pressure vessels, tanks, and piping and tubing
MJ-3.2 Pressure Vessels and Tanks
systems where the process contact surface of the weld
Joint designs shall be those permitted by ASME BPVC, is to be finished after welding, the welding processes
Section VIII, and shall comply with MJ-3.1. used shall be limited to the arc or high energy beam
(electron beam and laser beam) processes as defined in
MJ-3.3 Piping AWS A3.0. All welding procedures shall be qualified
Joint designs shall be those permitted by ASME B31.3, per MJ-5. All welders and welding operators shall be
and shall comply with MJ-3.1. qualified per MJ-6. The owner/user and contractor shall
agree that the welding process selected will provide the
MJ-3.4 Tubing desired results.
Joint designs for hygienic tubing and fittings shall be
square butt joints. The tubing and fittings shall have ends MJ-4.2 Welds Used in the As-Welded Condition
prepared by machining or facing to provide a square end For pressure vessels, tanks, and piping and tubing
that meets the requirements of Tables DT-3-1 and DT-3-2. systems where the process contact surface of the weld
The butt weld joints shall be properly cleaned within is to be used as is, welding processes shall be limited
1
2 in. (13 mm) of the joint area on the inside and outside to the inert-gas arc processes (such as gas tungsten-arc

119

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

welding and plasma arc welding) or the high energy Table MJ-6.3-1 Tube/Pipe Diameter Limits for
beam processes (such as electron beam or laser beam Orbital GTAW Performance Qualification
welding), as defined in AWS A3.0. All welding proce- Outside Diameter Qualified, in.
dures shall be qualified per MJ-5. All welders and weld- Outside Diameter of
Test Coupon, in. (mm)
ing operators shall be qualified per MJ-6. Every effort
(mm) Min. Max.
shall be made to use an automatic or machine welding
process. Autogenous welds, welds with filler wire, or 1
2 (13) and less None 1
2 (13)
consumable inserts are acceptable for this Standard pro- >12 (13) to 312 (89) >12 (13) 312 (89)
vided they meet the requirements for all applicable >312 (89) >312 (89) Unlimited
codes. The owner/user and contractor shall agree that
the welding process selected will provide the desired
results. Table MJ-6.3-2 Weld Thickness Limits for Orbital
GTAW Performance Qualification
MJ-4.3 Brazing
Deposited Weld Thickness
Joining of copper and copper alloy materials by braz- Qualified, in. (mm)
Thickness of Test
ing shall be in accordance with NFPA 99. All brazing Coupon, t, in. (mm) Min. Max.
procedures shall be qualified per MJ-5 of this Standard.
All brazers shall be qualified per MJ-6. <116 (1.5) t 2t
1
16 (1.5) t 38 (10) 1
16 (1.5) 2t
>38 (10) 3
16 (5) Unlimited
MJ-5 PROCEDURE QUALIFICATIONS
MJ-5.1 Pressure Vessels and Tanks
MJ-6 PERFORMANCE QUALIFICATIONS
Welding procedures for pressure vessels and tanks
shall be qualified in accordance with ASME BPVC, MJ-6.1 Pressure Vessels and Tanks
Section VIII. Welder and welding operator performance qualifica-
tions for pressure vessels and tanks shall be in accor-
MJ-5.2 Piping dance with ASME BPVC, Section VIII.
Welding procedures for piping systems shall be quali-
MJ-6.2 Piping
fied in accordance with ASME B31.3.
Welder and welding operator performance qualifica-
MJ-5.3 Tubing tions for piping systems shall be in accordance with
ASME B31.3. When the piping is to be used for hygienic
Welding procedures for hygienic tubing systems shall
systems, the essential variables for welding operators in
be qualified in accordance with ASME B31.3, with the
MJ-6.3 shall also apply.
following additions:
(a) A change in the type or nominal composition of MJ-6.3 Tubing
the backing (purge) gas shall require requalification.
Welder and welding operator performance qualifica-
(b) If filler metal is used, a change from one AWS
tions for hygienic tubing systems shall be in accordance
classification of filler metal to another, or to a proprietary
with ASME B31.3. This includes qualification of welders
filler metal, shall require requalification.
and welding operators who fabricate components in
This includes qualification of procedures for welding accordance with Part DT but not to those who manufac-
of components to Part DT but does not apply to longitu- ture tubes in accordance with a recognized standard.
dinal welds on tubes made in accordance with a recog- For the qualification of welding operators, the follow-
nized standard. ing essential variables also apply:
(a) welding of a joint using an edge preparation other
MJ-5.4 Duplex Stainless Steels
than a square groove.
In addition to the welding procedure specification test (b) the addition or deletion of solid backing.
requirements of ASME BPVC, Section IX, the weld metal (c) a change in the fit-up gap from that qualified.
and heat-affected zones from qualification test coupons (d) a change in pipe/tube diameter. See
of duplex stainless steels shall also meet the require- Table MJ-6.3-1.
ments of ASTM A923 Methods A and/or C. (e) the addition or deletion of filler metal.
(f) the addition or deletion of consumable inserts.
MJ-5.5 Brazing (g) a change in the thickness of the deposited weld
Brazing procedures for piping systems shall be quali- metal. See Table MJ-6.3-2.
fied in accordance with NFPA 99. (h) the addition or deletion of backing gas (purge gas).

120

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(i) a change in the current type or polarity. MJ-7.2.3 Tubing. All examiners, inspectors, and
(j) a change in the weld head type from open head Inspectors Delegates shall be qualified in accordance
to closed head or vice versa. with GR-4.
(k) a change from single pass to multipass welding
MJ-7.2.4 Tube Attachments. All examiners, inspec-
or vice versa, when using filler wire.
tors, and Inspectors Delegates shall be qualified in
In addition, either the original ASME BPVC, Section
accordance with GR-4.
IX qualification coupon or another tube-to-tube weld
coupon made by that same welding operator shall be MJ-7.2.5 Copper Tubing/Piping. All examiners,
visually examined and shall meet all the requirements inspectors, and Inspectors Delegates shall be qualified
of Table MJ-8.4-1. in accordance with GR-4.
Any change in the variables listed in MJ-6.3 requires
welding of a new test coupon, for which only visual MJ-7.2.6 Examination Personnel Eye Examination
inspection in accordance with Table MJ-8.4-1 is required. Requirements. Personnel performing examinations
Compliance with the variables in MJ-6.3 shall be shall have eye examinations as follows:
documented. (a) Near Vision Acuity. The individual shall have natu-
ral or corrected near distance acuity in at least one eye
MJ-6.4 Brazing such that the individual is capable of reading a minimum
Brazer performance qualifications, for piping systems, of a Jaeger Number 2 or equivalent type and size letter
shall be in accordance with NFPA 99 and shall be made at a distance designated on the chart but no less than
under an internal purge and exhibit full joint 12 in. (305 mm). This test shall be administered initially
penetration. and at least annually thereafter.
(b) Color Contrast. The individual shall demonstrate
the capability of distinguishing and differentiating con-
MJ-7 EXAMINATION, INSPECTION, AND TESTING trast among colors. This test shall be administered ini-
Owner/user, inspection contractor, and/or engineer tially and, thereafter, at intervals not exceeding 3 yr.
shall agree to the types of examinations, inspections, and These examinations shall be administered by an
testing unless otherwise specified in the applicable code. Ophthalmologist, Optometrist, Medical Doctor,
Registered Nurse or Nurse Practitioner, Certified
MJ-7.1 Examination Procedures Physician Assistant, or by other ophthalmic medical per-
MJ-7.1.1 Pressure Vessels and Tanks. Examination sonnel and shall include the state or province (or applica-
procedures for pressure vessels and tanks shall be in ble jurisdictional) license number.
accordance with ASME BPVC, Section VIII.
MJ-7.3 Examination, Inspection, and Testing
MJ-7.1.2 Piping. Examination procedures for piping Requirements
systems shall be in accordance with ASME B31.3.
MJ-7.3.1 Pressure Vessels and Tanks
MJ-7.1.3 Tubing. Examination procedures for tub-
(a) Examination. Examinations shall be performed in
ing systems shall be in accordance with ASME B31.3.
accordance with the provisions of ASME BPVC,
MJ-7.1.4 Tube Attachments. Examination proce- Section VIII. In addition, all welds having a process
dures for tubing systems shall be performed in accor- contact surface shall be visually examined by the
dance with ASME B31.3. fabricator.
MJ-7.1.5 Brazing. Examination procedures for (b) Inspection. In addition to the inspection required
brazed systems shall be in accordance with NFPA 99. by ASME BPVC, Section VIII, the owner/user or inspec-
tion contractor shall perform inspection(s) necessary to
MJ-7.2 Personnel Requirements ensure compliance with this Standard as well as any
additional requirements of the owner/user s
MJ-7.2.1 Pressure Vessels and Tanks. Personnel
performing examinations of pressure vessels and tanks specification.
designed to ASME BPVC, Section VIII, shall meet the (c) Testing. In addition to the testing required by
requirements of the appropriate section of that code. ASME BPVC, Section VIII, the owner/user or inspection
All inspectors shall be qualified in accordance with contractor shall perform testing necessary to ensure
GR-4.1. compliance with this Standard as well as any additional
All Inspectors Delegates shall meet the requirements requirements of the owner/users specification.
of GR-4.2. MJ-7.3.2 Piping
MJ-7.2.2 Piping. All examiners, inspectors, and (a) Examination. Examinations shall be performed in
Inspectors Delegates shall be qualified in accordance accordance with the provisions of the specified fluid
with GR-4. service in ASME B31.3.

121

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(b) Inspection. Owner/user, inspection contractor, service in ASME B31.3. The external surfaces of all welds
and/or engineer shall agree to the minimum percentage shall be visually examined.
of process contact welds to be selected for borescopic (b) Inspection. Visual inspection shall be performed
or direct visual inspection, and they shall inform the on all process contact surfaces affected by the attachment
installation contractor. The inspection contractor shall welding.
submit an inspection plan to ensure that welds meet the (c) Testing. Testing shall be performed in conjunction
acceptance criteria of this Part. This plan shall include with the system test.
borescopic or direct visual inspection of the process con-
MJ-7.3.5 Brazing
tact surfaces on at least 20% of the welds in each system
installed. A representative sample of each welders and/ (a) Examination. Examinations shall be performed in
or welding operator s work (as applicable) must be accordance with NFPA 99.
included. (b) Inspection. Owner/user, inspection contractor,
The examination required for compliance with and/or engineer shall agree to the minimum percentage
ASME B31.3 may be included in the minimum inspec- of brazed joints to be selected for direct visual inspection,
tion percentage, provided those examinations were and they shall inform the installation contractor. The
direct visual or borescopic and of the process contact inspection contractor shall submit an inspection plan to
surface. ensure that joints meet the acceptance criteria of this
(c) Testing. Leak testing of piping systems shall be Part. A representative sample of each brazer s work
performed in accordance with the specified fluid service must be included.
requirements in ASME B31.3. (c) Testing. Leak testing of copper systems shall be
performed in accordance with the specified fluid service
MJ-7.3.3 Tubing requirements in ASME B31.3.
(a) Examination. Examinations shall be performed in
accordance with the provisions of the specified fluid MJ-7.4 Records
service in ASME B31.3. The external surfaces of all welds See GR-5.
shall be visually examined.
If ASME B31.3 High Purity Fluid Service (Chapter X)
is specified, radiographic, ultrasonic, or in-process MJ-8 ACCEPTANCE CRITERIA
examination is not required unless specified by the MJ-8.1 General
owner/user.
Welding for a sterile environment requires that the
(b) Inspection. Owner/user, inspection contractor, weld shall not result in a surface that will contribute to
and/or engineer shall agree to the minimum percentage microbiological growth and contamination of the prod-
of process contact welds to be selected for borescopic uct. The weld shall not have any discontinuities such
or direct visual inspection, and they shall inform the as cracks, voids, porosity, or joint misalignment that will
installation contractor. The inspection contractor shall promote contamination of the product. All welding pro-
submit an inspection plan to ensure that welds meet the cedures shall be qualified to MJ-5.
acceptance criteria of this Part. This plan shall include
borescopic or direct visual inspection of the process con- MJ-8.2 Pressure Vessel and Tank Welds
tact surfaces on at least 20% of the welds in each system
Weld acceptance criteria for pressure vessels and
installed. A representative sample of each welders and/
tanks shall be in accordance with ASME BPVC,
or welding operator s (as applicable) work must be
Section VIII, with the additional requirements of
included. There shall also be a plan for inspecting a
Table MJ-8.2-1.
representative sample of each welders and/or welding
operators (as applicable) first shift of production. A MJ-8.3 Piping Welds
procedure shall be submitted for inspecting blind welds.
Weld acceptance criteria for piping shall be in accor-
The random selection of accessible welds to be inspected
dance with the specified fluid service of ASME B31.3.
shall be up to the owner/users inspectors discretion.
The additional requirements of Table MJ-8.3-1 shall
The examination required for compliance with
apply. See SD-3.1.1 for cautionary information if using
ASME B31.3 may be included in the minimum inspec-
pipe instead of tube for hygienic systems.
tion percentage provided those examinations were
visual or borescopic and of the process contact surface. MJ-8.4 Tubing Welds
(c) Testing. Leak testing of tubing systems shall be Weld acceptance criteria (including borescopic accept-
performed in accordance with the specified fluid service ance criteria) for tubing and components shall be in
requirements in ASME B31.3. accordance with Table MJ-8.4-1 (see Fig. MJ-8.4-1). This
MJ-7.3.4 Tube Attachments includes welds on components but not longitudinal
(a) Examination. Examinations shall be performed in welds on tubes manufactured in accordance with a rec-
accordance with the provisions of the specified fluid ognized standard.

122

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Preproduction sample welds, when required, shall be materials, nor are all methods acceptable for all pro-
submitted by the contractor to the owner/user to estab- cesses. The selection of materials of construction and
lish weld quality. Owner/user, contractor, and inspec- joining techniques are based upon application
tion contractor shall agree to the number and type of requirements.
sample welds.
During construction, sample welds shall be made on MJ-9.2 Weld Joint Design and Preparation
a regular basis to verify that the equipment is operating The weld surfaces to be joined shall be properly
properly and that the purging setup is adequate to pre- aligned. This may include planing or facing of the com-
vent discoloration beyond the level agreed upon by the ponents. The weld surfaces shall be protected against
owner/user and contractor. Owner/user and contractor adverse environmental influences, including excessive
shall agree to the frequency of sample welds. It is moisture, extreme temperature conditions, excessive
strongly recommended that these sample welds be made drafts, and contamination sources (e.g., dirt, dust, oil,
at the beginning of each work shift, whenever the purge foreign material shavings).
source bottle is changed, and when the automatic or
machine welding equipment is changed (such as when MJ-9.2.1 Tubing and Piping. Joint designs for tubing,
the orbital tube weld head is changed). piping, and fittings shall be square butt joints. Joining
The sample welds described in the preceding para- surfaces shall have ends prepared by molding, cutting,
graphs, and any associated welding machine printed machining, or facing to provide a square end that meets
records (e.g., welding parameter printouts directly from requirements for the applicable Welding Procedure
welding machine or downloaded from a welding Specification (WPS).
machine), if any, may be disposed of after written accept-
MJ-9.3 Joining Processes and Procedures
ance of the coupons by the owner, the owners represen-
tative, or the inspector. Polymer tube and pipe systems are joined by a variety
of heat fusion welding methods, including beadless
MJ-8.4.1 Sample Welds. Sample welds for tubing fusion, noncontact infrared (IR) fusion, contact butt
shall meet all the acceptance criteria of Table MJ-8.4-1. fusion, and socket fusion. Fusion does not require sol-
An internal bead width of 1.0 to 2.5 times the nominal vents or glue to join material, and nothing is added or
wall thickness is required. changed chemically between the two components being
MJ-8.4.2 Rewelding. Rewelding (reflow) may be joined. Other joining methods may be used when agreed
attempted one time only for the following defects: upon by the owner/user. Joining of polymers shall be
(a) incomplete penetration (lack of penetration) performed in accordance with a documented WPS that
(b) incomplete fusion (lack of fusion) is qualified in accordance with MJ-9.4. The owner/user,
(c) unconsumed tack welds that can be inspected on contractor, and manufacturer shall agree that the weld-
the process contact side ing process selected will provide the desired results.
All rewelds shall either totally consume the original MJ-9.3.1 Beadless Welding. Beadless welding (a
weld or overlap the original weld with no base metal material-dependent process) shall be used where in-
between the welds. place drainage and bioburden control are required (see
MJ-8.5 Tube-Attachment Welds Fig. MJ-9.7.1-1) (reference SD-2.4.3).

The acceptance criteria for tube-attachment welds MJ-9.3.1.1 Records. Weld equipment should mon-
shall be in accordance with Table MJ-8.5-1. itor and record critical weld parameters such as heat,
cool time, and temperature. If the equipment does not
MJ-8.5.1 Sample Welds. Sample welds are not have monitoring or recording capabilities, weld data
required for tube-attachment welds or seal welds. shall be recorded in welding protocols or on data
MJ-8.5.2 Rewelding. Rewelding is allowed, except carriers.
for welds that are process contact surfaces, for which
MJ-9.3.2 Noncontact IR and Contact Butt Fusion
the rewelding restrictions of MJ-8.4.2 apply.
Welding. Noncontact infrared (IR) and contact butt
MJ-8.6 Brazed Joints fusion are not suitable joining processes for systems
requiring drainability and bioburden control. Either may
Brazed joint acceptance criteria shall be in accordance
be acceptable for single use applications. Refer to the
with NFPA 99.
WPS or manufacturers written procedures.

MJ-9 JOINING OF POLYMERIC MATERIALS MJ-9.3.3 Socket Fusion Welding. Socket fusion is not
suitable for systems requiring drainability or bioburden
MJ-9.1 General control. Socket fusion may be acceptable for single use
Polymeric materials are described in Part PM. All join- applications where approved by the owner/user for the
ing techniques may not be available for all polymeric intended service.

123

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Refer to the WPS or manufacturer s written MJ-9.6.3 Examination, Inspection, and Testing
procedures. Requirements
MJ-9.4 Procedure Qualifications MJ-9.6.3.1 Examination. Examinations shall be
Welding procedures shall be qualified in accordance performed in accordance with the provisions of the spec-
with AWS B2.4. A WPS shall be provided for each poly- ified fluid service in ASME B31.3.
mer and process being used. Environmental condition The external surfaces of all welds shall be visually
recommendations shall be included in the WPS. examined. If ASME B31.3, High Purity Fluid Service
(Chapter X) is specified, radiographic, ultrasonic, or in-
MJ-9.5 Performance Qualifications process examination is not required unless specified by
Welder and welding operator performance qualifica- the owner/user.
tions shall be in accordance with AWS B2.4. The quality Preproduction sample welds, when required, shall be
of polymeric weld joints depends on the qualification submitted by the contractor to the owner/user to estab-
of the welders and welding operators, the suitability lish weld quality. The owner/user, contractor, and
of the equipment used, environmental influences, and inspection contractor shall agree to the number and type
adherence to the applicable WPS. Welders and welding of sample welds. During construction, sample welds
operators shall be trained and possess a valid qualifica- shall be made on a regular basis to verify that the equip-
tion certificate from the manufacturer for the process ment is operating properly and that the setup is ade-
and material being welded. quate to prevent discoloration beyond the level agreed
MJ-9.6 Examination, Inspection, and Testing upon by the owner/user and contractor. The owner/
user and contractor shall agree to the frequency of sam-
Examination, inspection, and testing criteria and ple welds. It is strongly recommended that these sample
methods are dictated by material type and joining welds be made at the beginning of each work shift and
method. Owner/user, inspection contractor, and/or when changing the welder and/or welding operator (as
engineer shall agree to the types of examinations, inspec- applicable) and welding equipment.
tions, and testing unless otherwise specified in the appli-
The sample welds described in the preceding para-
cable code.
graphs, and any associated welding machine printed
MJ-9.6.1 Examination Procedures. Written visual records (e.g., welding parameter printouts directly from
examination procedures shall be used. welding machine or downloaded from a welding
machine), if any, may be disposed of after written accept-
MJ-9.6.2 Personnel Requirements
ance of the coupons by the owner, the owners represen-
MJ-9.6.2.1 Personnel Qualifications. All examin- tative, or the inspector.
ers, inspectors, and Inspectors Delegates shall be quali-
fied in accordance with GR-4 and shall be trained and MJ-9.6.3.2 Inspection. Owner/user, inspection
possess a valid qualification certificate from the manu- contractor, and/or engineer shall agree to the minimum
facturer for the process and material being welded. percentage of process contact welds to be selected for
borescopic or direct visual inspection, and they shall
MJ-9.6.2.2 Examination Personnel Eye Examination
Requirements. Personnel performing examinations inform the installation contractor. The inspection con-
shall have eye examinations as follows: tractor shall submit an inspection plan to ensure that
(a) Near Vision Acuity. The individual shall have natu- welds meet the acceptance criteria of this Part. This plan
ral or corrected near distance acuity in at least one eye shall include borescopic or direct visual inspection of
such that the individual is capable of reading a minimum the process contact surfaces or visual inspection with
of a Jaeger Number 2 or equivalent type and size letter light illumination of the weld cross sections on at least
at a distance designated on the chart but no less than 20% of the welds in each system installed. A representa-
12 in. (305 mm). This test shall be administered initially tive sample of each welders and/or welding operators
and at least annually thereafter. (as applicable) work shall be included. There shall also
(b) Color Contrast. The individual shall demonstrate be a plan for inspecting a representative sample of each
the capability of distinguishing and differentiating con- welders and/or welding operators (as applicable) first
trast among colors. This test shall be administered ini- shift of production. A procedure shall be submitted for
tially and, thereafter, at intervals not exceeding 3 yr. inspecting blind welds. The random selection of accessi-
These examinations shall be administered by an ble welds to be inspected shall be up to the owner/
Ophthalmologist, Optometrist, Medical Doctor, users inspectors discretion. The examination required
Registered Nurse or Nurse Practitioner, Certified for compliance with ASME B31.3 may be included in
Physician Assistant, or by other ophthalmic medical per- the minimum inspection percentage, provided those
sonnel and shall include the state or province (or applica- examinations were visual or borescopic and of the pro-
ble jurisdictional) license number. cess contact surface.

124

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

MJ-9.6.3.3 Testing. Hydrostatic leak testing shall (g) Concavity. Maximum inside diameter (I.D.) con-
be performed in accordance with the specified fluid ser- cavity shall be limited to 10% of the nominal wall thick-
vice requirements in ASME B31.3. Hydrostatic leak test- ness [see Fig. MJ-9.7.1-1, illustration (h)].
ing shall never exceed the manufacturers rating of the
MJ-9.7.2 Acceptance Criteria for Nonbeadless
system installed.
Welds. Acceptance criteria for nonbeadless welds in
The use of pneumatic testing is not recommended on
piping shall be in accordance with AWS G1.10M or
these systems.
DVS 2202-1.
MJ-9.6.4 Records. See GR-5.
MJ-9.7.3 Acceptance Criteria for Sample Welds.
MJ-9.7 Weld Acceptance Criteria Sample welds shall meet all the acceptance criteria of
Common visual acceptance criteria include complete MJ-9.7.1.
bonding of joining surface, straight and aligned joints,
MJ-9.7.4 Rewelding. Rewelding is not allowed.
and exclusion of dirt and foreign substances in the
weld zone. MJ-9.8 Documentation Requirements
MJ-9.7.1 Acceptance Criteria for Beadless Welds. The following documentation shall be presented to
An acceptable beadless weld is shown in Fig. MJ-9.7.1-1, the owner/user or their designee, as a minimum:
illustration (a). Weld acceptance criteria shall be in accor-
(a) Welding Documentation. Welding Procedure
dance with the following:
Specifications (WPS) used, their Procedure Qualification
(a) Cracks and Crevices. Any crack or crevice would Records (PQR), and Welder Performance Qualifications
generally indicate lack of full penetration welds. Internal (WPQ)/Performance Qualification Test Records
or external cracks or crevices shall not be permitted in (PQTRs) and/or Welding Operator Performance
the weld zone [see Fig. MJ-9.7.1-1, illustration (b)]. Qualifications (WOPQ).
(b) Pits and Pores. Pits and pores shall not be present
(b) Weld Maps. When required by the owner/user,
in the weld zone on the interior surface [see
weld maps of bioprocessing components, weld inspec-
Fig. MJ-9.7.1-1, illustration (c)].
tion logs of bioprocessing components (including type
(c) Voids. Voids or microbubbles in the weld zone are and date of inspection), and welder and/or welding
the result of molten material shrinking as it cools, leaving operator identification of each weld shall be provided
small voids, usually in the center of the weld, due to either on the weld map or on the inspection log.
volume displacement. They are not uncommon in Fusion equipment that electronically stores welding
beadless welding, and their presence alone is not reason histories and serializes welds should be used. Welding
for rejection. history shall be turned over, in printed or electronic
(1) Maximum single void diameter shall be 10% of format, to the owner/user upon completion of work
nominal wall thickness. and as part of the Installation Qualification (IQ) process.
(2) Maximum total for all void diameters in a given (c) Materials. All molded fittings, molded valves, and
cross-sectional examination shall be 10% of nominal wall extruded piping shall be intrinsically identified to pro-
thickness [see Fig. MJ-9.7.1-1, illustration (d)]. vide, as a minimum, material of construction, lot num-
(d) Fit-Up and Mismatch. Components shall be ber, and date of production to ensure traceability.
aligned so as to prevent hold-up that would contribute Certificates of compliance shall be provided for
to contamination of the product. The maximum mis- molded/extruded components not individually labeled.
alignment is 10% of nominal wall thickness [see
(d) Testing Records. Other records (e.g., pressure test,
Fig. MJ-9.7.1-1, illustration (e)]. It is not recommended to
surface finish) shall be provided as required by the
join polymer components of different wall thicknesses.
owner/user.
(e) Inclusions. Any dark, visible inclusion(s) or
speck(s) on the process contact surface of the weld zone
are considered foreign materials and are not acceptable MJ-10 DOCUMENTATION REQUIREMENTS
[see Fig. MJ-9.7.1-1, illustration (f)].
(f) Discoloration. Slight discoloration in the weld zone The requirements for metallic materials and weld doc-
is not uncommon in beadless welding. Slight discolor- umentation are listed in GR-5. For polymeric materials,
ation would include up to a light straw color in the see MJ-9.8.
weld zone. Dark color on the surface or at the weld
interface could indicate improper cleaning or joint prep-
MJ-11 PASSIVATION
aration and is rejectable [see Fig. MJ-9.7.1-1,
illustration (g)]. Refer to SD-3.1.2.3(i).

125

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Pressure Vessels and Tanks
Welds on Process Contact Surfaces Welds on Nonprocess Contact Surfaces
Welds Left in the As- Prior to Postweld Welds Left in the After Postweld
Discontinuities Welded Condition Finishing After Postweld Finishing As-Welded Condition Finishing

Cracks None None None None None


Lack of fusion None None None None None
Incomplete None on process con- None on process con- None on process See Notes (1) See Notes (1)
penetration tact side; otherwise, tact side; otherwise, contact side; otherwise, and (2) and (2)
see Note (1) see Note (1) see Note (1)
Porosity None open to the sur- See Note (1) None open to the surface; None open to the sur- None open to the sur-
face; otherwise, see otherwise, see Note (1) face; otherwise, see face; otherwise, see
Note (1) Note (1) Note (1)
Inclusions None open to the sur- See Note (1) None open to the surface; None open to the sur- None open to the sur-
[metallic face; otherwise, see otherwise, see Note (1) face; otherwise, see face; otherwise, see
(e.g., tung- Note (1) Note (1) Note (1)
sten) or non-
metallic]
Undercut None See Note (1) None See Note (1) See Note (1)
Groove weld See Note (1) See Note (1) Maximum of 10% of the See Note (1) See Note (1)
concavity nominal wall thickness of
thinner member
Fillet weld con- 116 in. (1.5 mm) max. Per applicable design 1
32 in. (0.8 mm) max. See Note (1) See Note (1)
vexity and fabrication code
Discoloration Heat affected zone N/A Heat affected zone (HAZ) Per customer specifi- Per customer specifi-
(heat (HAZ) may be permit- may be permitted to cation cation
affected ted to have light straw have light straw to light
zone) to light blue color (see blue color (see Figs.
Figs. MJ-8.4-2 and MJ-8.4-2 and MJ-8.4-3).
MJ-8.4-3). Any discolor- Any discoloration present
ation present must be must be tightly adhering
tightly adhering to the to the surface such that
surface such that nor- normal operations will
mal operations will not not remove it. In any
remove it. In any case, case, the HAZ shall have
the HAZ shall have no no evidence of rust, free
evidence of rust, free iron, or sugaring. See
iron, or sugaring. See Note (3).
Note (3).
Discoloration None allowed. For welds N/A None allowed. For welds Per customer specifi- Per customer specifi-
(weld bead) in nickel alloys, and in nickel alloys, and for cation cation
for welds in superaus- welds in superaustenitic
tenitic alloys made alloys made with nickel
with nickel alloy alloy inserts or filler met-
inserts or filler metals, als, slag is permitted as
slag is permitted as long as it is silver to
long as it is silver to light gray in color and
light gray in color and adherent to the surface.
adherent to the sur- See Note (3).
face. See Note (3).

126

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Pressure Vessels and Tanks (Contd)
Welds on Process Contact Surfaces Welds on Nonprocess Contact Surfaces
Welds Left in the As- Prior to Postweld Welds Left in the After Postweld
Discontinuities Welded Condition Finishing After Postweld Finishing As-Welded Condition Finishing
1
Reinforcement See Note (1) See Note (1) 32 in. (0.8 mm) max. See Note (1) See Note (1)
Tack welds See Note (1) N/A N/A See Note (1) N/A
Arc strikes None N/A None None None
Overlap None None None None None
Weld bead
width N/A N/A N/A N/A N/A
Minimum fillet
weld size See Note (1) See Note (1) See Note (1) See Note (1) See Note (1)
Misalignment
(mismatch) See Note (1) See Note (1) See Note (1) See Note (1) See Note (1)

NOTES:
(1) The limits of ASME BPVC, Section VIII shall apply.
(2) Does not apply to insulation sheathing and similar welds.
(3) Welds on pressure vessels or tanks that have been in service may require unique criteria.

127

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Pipe


Welds on Process Contact Surfaces Welds on Nonprocess Contact Surfaces
Welds Left in the As- Prior to Postweld After Postweld Welds Left in the As- After Postweld
Discontinuities Welded Condition Finishing Finishing Welded Condition Finishing

Cracks None None None None None


Lack of fusion None None None None None
Incomplete pene- None None on process con- None on process con- See Notes (1) and (2) See Notes (1) and (2)
tration tact side; otherwise, tact side; otherwise,
see Note (1) see Note (1)
Porosity None open to the sur- See Note (1) None open to the sur- None open to the sur- None open to the sur-
face; otherwise, see face; otherwise, see face; otherwise, see face; otherwise, see
Note (1) Note (1) Note (1) Note (1)
Inclusions [metallic None open to the sur- See Note (1) None open to the sur- None open to the sur- None open to the sur-
(e.g., tungsten) or face; otherwise, see face; otherwise, see face; otherwise, see face; otherwise, see
nonmetallic] Note (1) Note (1) Note (1) Note (1)
Undercut None See Note (1) None See Note (1) See Note (1)
Concavity See Note (1) See Note (1) See Note (1) See Note (1) See Note (1)
1 1
Fillet weld 16 in. (1.5 mm) max. See Note (1) 32 in. (0.8 mm) max. See Note (1) See Note (1)
convexity
Discoloration (heat Heat affected zone N/A, see Note (3) Heat affected zone Per customer specifi- Per customer specifi-
affected zone) (HAZ) may be permit- (HAZ) may be permit- cation cation
ted to have light straw ted to have light
to light blue color (see straw to light blue
Figs. MJ-8.4-2 and color (see Figs.
MJ-8.4-3). Any discolor- MJ-8.4-2 and
ation present must be MJ-8.4-3). Any discol-
tightly adhering to the oration present must
surface such that nor- be tightly adhering
mal operations will not to the surface such
remove it. In any case, that normal opera-
the HAZ shall have no tions will not remove
evidence of rust, free it. In any case, the
iron, or sugaring. See HAZ shall have no
Note (3). evidence of rust,
free iron, or sug-
aring. See Note (3).
Discoloration (weld None allowed. For welds N/A, see Note (3) None allowed. For Per customer specifi- Per customer specifi-
bead) in nickel alloys, and welds in nickel cation cation
for welds in superaus- alloys, and for welds
tenitic alloys made in superaustenitic
with nickel alloy alloys made with
inserts or filler metals, nickel alloy inserts
slag is permitted as or filler metals, slag
long as it is silver to is permitted as long
light gray in color and as it is silver to light
adherent to the sur- gray in color and
face. See Note (3). adherent to the sur-
face. See Note (3).

128

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Pipe (Contd)
Welds on Process Contact Surfaces Welds on Nonprocess Contact Surfaces
Welds Left in the As- Prior to Postweld After Postweld Welds Left in the As- After Postweld
Discontinuities Welded Condition Finishing Finishing Welded Condition Finishing
1
Reinforcement See Note (1) See Note (1) 32 in. (0.8 mm) max. See Note (1) See Note (1)
Must be fully con- Must be fully con- Must be fully con-
sumed by final weld sumed by final weld sumed by final weld Per customer specifi- Per customer specifi-
Tack welds bead bead bead cation cation
Arc strikes None None None None None
Overlap None None None None None
Weld bead width N/A N/A N/A N/A N/A
Minimum fillet
weld size See Note (1) See Note (1) See Note (1) See Note (1) See Note (1)
Misalignment (mis-
match) See Note (1) See Note (1) See Note (1) See Note (1) See Note (1)

NOTES:
(1) The limits of ASME B31.3 shall apply.
(2) Does not apply to insulation sheathing and similar welds.
(3) Special surface preparation may be needed to meet the criteria. Welds on piping that has been in service may require unique criteria.

129

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Tube-to-Tube Butt Joints
Discontinuities Welds on Process Contact Surfaces Welds on Nonprocess Contact Surfaces

Cracks None None


Lack of fusion None None
Incomplete penetration None [see Fig. MJ-8.4-1, illustration (e)] None [see Fig. MJ-8.4-1, illustration (e)]
Porosity None open to the surface; otherwise, see Note (1). None open to the surface; otherwise, see Note (1).
Inclusions [metallic None open to the surface; otherwise, see Note (1). See Note (1)
(e.g., tungsten) or
nonmetallic]
Undercut None See Note (1)
Concavity 10% Tw max. [see Fig. MJ-8.4-1, illustrations (c) and (d)]. 10% Tw max. [see Fig. MJ-8.4-1, illustrations (c) and
However, O.D. and I.D. concavity shall be such that the (d)] over entire circumference with up to 15% Tw
wall thickness is not reduced below the minimum thick- permitted over a maximum of 25% of the circum-
ness required in DT-3 [see Note (2)]. ference [see Note (2)].
Convexity 10% Tw max. [see Fig. MJ-8.4-1, illustration (f)] [see 0.015 in. (0.38 mm) max. [see Fig. MJ-8.4-1, illus-
Note (2)] tration (f)] [see Note (2)].
Discoloration Heat-affected zone (HAZ) may be permitted to have light Discoloration level will be agreed upon between
(heat-affected zone) straw to light blue color (see Figs. MJ-8.4-2 and the owner/user and contractor. Postweld condi-
MJ-8.4-3). Any discoloration present must be tightly tioning may be allowed to meet discoloration
adhering to the surface such that normal operations requirements at the discretion of the owner/user.
will not remove it. In any case, the HAZ shall have no See Note (3).
evidence of rust, free iron, or sugaring. See Note (3).
Discoloration None allowed. For welds in nickel alloys, and for welds Discoloration level will be agreed upon between
(weld bead) in superaustenitic alloys made with nickel alloy inserts the owner/user and contractor. Postweld condi-
or filler metals, slag is permitted as long as it is silver tioning may be allowed to meet discoloration
to light gray in color and adherent to the surface. See requirements at the discretion of the owner/user.
Note (3). See Note (3).
Reinforcement See Convexity See Convexity
Tack welds Must be fully consumed by final weld bead [see Note Same as process contact side.
(4)]
Arc strikes None See Note (5)
Overlap None None
Weld bead width No limit provided that complete joint penetration is If process contact surface cannot be inspected
achieved. (such as I.D. of a tube beyond the reach of
remote vision equipment), then the nonprocess
contact surface weld bead shall be straight and
uniform around the entire weld circumference [see
Fig. MJ-8.4-4, illustration (a)]. The minimum weld
bead width shall not be less than 50% of the
maximum weld bead width [see Fig. MJ-8.4-4,
illustration (b)]. The maximum weld bead mean-
der shall be 25% of the weld bead width, mea-
sured as a deviation from the weld centerline, as
defined in Fig. MJ-8.4-4, illustration (c).
Minimum throat N/A N/A
Misalignment (mis- 15% Tw max. [see Fig. MJ-8.4-1, illustration (b)], except Same as process contact surfaces
match) [Note (6)] that 4 in. tube may have a maximum of 0.015 in.
(0.38 mm) misalignment on the O.D. and 6 in. tube
may have a maximum of 0.030 in. (0.76 mm) misalign-
ment on the O.D. Figure MJ-8.4-1, illustration (b) does
not apply to 4 in. and 6 in. tube [see Note (2)].

130

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Tube-to-Tube Butt Joints
(Contd)
GENERAL NOTE: Includes all product forms (e.g., tube, fittings, castings, forgings, and bar) whose final dimensions meet Part DT requirements.
NOTES:
(1) The limits of ASME B31.3 shall apply.
(2) Tw is the nominal wall thickness of the thinner of the two members being joined. Weld metal must blend smoothly into base metal.
(3) Welds on tubing that has been in service may require unique criteria.
(4) Any weld that shows unconsumed tack welds on the nonprocess contact surface must be inspected on the process contact surface;
otherwise they are rejected. If the weld cannot be inspected on the process contact surface, rewelding per MJ-8.4.2 is not allowed.
Rewelding per MJ-8.4.2 is allowed if the weld can be inspected on the process contact surface after rewelding.
(5) Arc strikes on the nonprocess contact surface may be removed by mechanical polishing as long as the minimum design wall thickness
is not compromised.
(6) Note that misalignment is controlled on the O.D. and is based on allowable O.D. dimensions and tolerances of fittings and tubing. The
owner/user is cautioned that this can result in greater I.D. misalignment because this also takes into consideration the wall thickness
dimensions and tolerances of fittings and tubing. However, there are no specified I.D. misalignment acceptance criteria.

131

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Tube Welds

132

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. MJ-8.4-2 Discoloration Acceptance Criteria for Weld Heat-Affected Zones on Electropolished 316L Tubing

Sample #1a Sample #1b

Sample #2 Sample #3

Sample #4 Sample #5
The weld bead shall have no discoloration. Weld heat-affected zones on electropolished 316L tubing having discoloration levels no worse
than Samples #1 through #4 in the as-welded condition are acceptable. Heat-affected zone discoloration levels more severe than that shown
in Sample #4 are unacceptable. Sample #5 shows an unacceptable weld and heat-affected zone discoloration for comparison. The user is
cautioned that the colors observed during direct visual examination or borescope examination will be different viewing directly down (90 deg)
at the surface compared with viewing at a lower angle along the edges.

GENERAL NOTE: The user is cautioned that electronic versions or photocopies of these acceptance criteria shall not be used for evaluation
of sample or production welds since subtle differences in color can influence weld acceptability. Nonmandatory Appendix M explains the
technique by which these acceptance criteria were determined.
This figure is also available as a stand-alone document from ASME as ASME BPE-EP-2014.

133

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. MJ-8.4-3 Discoloration Acceptance Criteria for Weld Heat-Affected Zones on Mechanically
Polished 316L Tubing

Sample #1a Sample #1b

Sample #2 Sample #3

Sample #4 Sample #5
The weld bead shall have no discoloration. Weld heat-affected zones on mechanically polished 316L tubing having discoloration levels no
worse than Samples #1 through #3 in the as-welded condition are acceptable. Heat-affected zone discoloration levels more severe than that
shown in Sample #3 are unacceptable. Samples #4 and #5 show unacceptable welds and heat-affected zone discoloration for comparison.
The user is cautioned that the colors observed during direct visual examination or borescope examination will be different viewing directly
down (90 deg) at the surface compared with viewing at a lower angle along the edges.
GENERAL NOTE: The user is cautioned that electronic versions or photocopies of these acceptance criteria shall not be used for evaluation
of sample or production welds since subtle differences in color can influence weld acceptability. Nonmandatory Appendix M explains the
technique by which these acceptance criteria were determined.
This figure is also available as a stand-alone document from ASME as ASME BPE-MP-2014.

134

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. MJ-8.4-4 Acceptable and Unacceptable Weld Bead Width and Meander

GENERAL NOTE: Applies only to nonproduct contact surfaces and only if weld on product contact surface cannot be inspected.

135

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table MJ-8.5-1 Visual Examination Acceptance Criteria for Tube-Attachment Welds


Groove Welds [Note (1)] Fillet Welds
Welds on Process Welds on Nonprocess Welds on Process Welds on Nonprocess
Discontinuities Contact Surfaces Contact Surfaces Contact Surfaces Contact Surfaces

Cracks None None None None


Lack of fusion None None None None
Incomplete pene- None None N/A [Note (2)] N/A
tration
Porosity None open to the sur- None open to the surface; None open to the sur- none open to the surface;
face; otherwise, see otherwise, see Note (3) face; otherwise, see otherwise, see Note (3)
Note (3) Note (3)
Inclusions None open to surface None open to surface None open to surface None open to surface
[metallic (e.g.,
tungsten) or
nonmetallic]
Undercut None See Note (3) None, see Note (4) See Notes (3) and (5)
Concavity 10% Tw max. [see 10% Tw [see Fig. MJ-8.4-1, 10% Tw max. [see Fig. N/A, see Note (5)
Fig. MJ-8.4-1, illustra- illustrations (c) and (d)] MJ-8.5-1, illustration
tions (c) and (d)]. How- over entire circumference (a) and Notes (4) and
ever, O.D. and I.D. with up to 15% Tw permit- (6)
concavity shall be ted over a maximum of
such that the wall 25% of the circumference
thickness is not [see Note (6)]
reduced below the
minimum thickness
required in DT-3 [see
Note (6)].
Convexity 10% Tw max. 0.015 in. (0.38 mm) max. 10% Tw max. [see Fig. N/A
and Note (3) MJ-8.5-1, illustration
(b) and Note (6)]
Discoloration (heat Heat affected zone Discoloration level will be Heat affected zone Discoloration level will be
affected zone) (HAZ) may be permit- agreed upon between the (HAZ) may be permit- agreed upon between the
ted to have light straw owner/user and contractor. ted to have light straw owner/user and contractor.
to light blue color (see Postweld conditioning may to light blue color (see Postweld conditioning may
Figs. MJ-8.4-2 and be allowed to meet discol- Figs. MJ-8.4-2 and be allowed to meet discol-
MJ-8.4-3). Any discolor- oration requirements at the MJ-8.4-3). Any discolor- oration requirements at the
ation present must be discretion of the ation present must be discretion of the
tightly adhering to the owner/user. See Note (7). tightly adhering to the owner/user. See Note (7).
surface such that nor- surface such that nor-
mal operations will mal operations will
not remove it. In any not remove it. In any
case, the HAZ shall case, the HAZ shall
have no evidence of have no evidence of
rust, free iron, or sug- rust, free iron, or sug-
aring. See Note (7). aring. See Note (7).
Discoloration (weld None allowed. For Discoloration level will be None allowed. For Discoloration level will be
bead) welds in nickel alloys, agreed upon between the welds in nickel alloys, agreed upon between the
and for welds in super- owner/user and contractor. and for welds in super- owner/user and contractor.
austenitic alloys made Postweld conditioning may austenitic alloys made Postweld conditioning may
with nickel alloy be allowed to meet discol- with nickel alloy be allowed to meet discol-
inserts or filler metals, oration requirements at the inserts or filler metals, oration requirements at the
slag is permitted as discretion of the slag is permitted as discretion of the
long as it is silver to owner/user. See Note (7). long as it is silver to owner/user. See Note (7).
light gray in color and light gray in color and
adherent to the sur- adherent to the sur-
face. See Note (7). face. See Note (7).

136

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table MJ-8.5-1 Visual Examination Acceptance Criteria for Tube-Attachment Welds (Contd)
Groove Welds [Note (1)] Fillet Welds
Welds on Process Welds on Nonprocess Welds on Process Welds on Nonprocess
Discontinuities Contact Surfaces Contact Surfaces Contact Surfaces Contact Surfaces

Reinforcement See Convexity See Convexity N/A N/A


Tack welds Must be fully consumed Must be fully consumed by Must be fully consumed Must be fully consumed by
by final weld bead; final weld bead; see Note by final weld bead; final weld bead; see Note
see Note (8) (9) see Note (8) (9)
Arc strikes None See Note (10) None See Note (10)
Overlap None None None None
Weld bead width N/A N/A N/A N/A
Minimum fillet N/A N/A Per Client Spec. and Per Client Spec. and Note
weld size Note (4) (5)
Misalignment N/A as long as other N/A as long as other condi- N/A N/A
(mismatch) conditions are met tions are met

GENERAL NOTE: Tube attachment welds include groove welds and fillet welds in various joint configurations, such as proximity stems on
jumpers on transfer panels, transfer panel nozzles, and locator pins on sprayballs.
NOTES:
(1) Any weld where penetration is required into the joint.
(2) Penetration to the process contact surfaces is neither required nor prohibited. Welds that penetrate through to the process contact
surface may exhibit intermittent penetration. Weld penetration through to the process contact surface must meet all other process
contact surface requirements of this table.
(3) The limits of ASME B31.3 shall apply.
(4) For welds designated by the owner/user as seal welds, there is no minimum fillet weld size or throat. Concavity requirements are not
applicable.
(5) For welds designated by the owner/user as seal welds, there is no minimum fillet weld size or throat. Concavity and undercut require-
ments are not applicable.
(6) Tw is the nominal thickness of the thinner of the two members being joined. Weld metal must blend smoothly into base metal.
(7) Welds on tube attachments that have been in service may require unique criteria.
(8) Rewelding per MJ-8.5-2 is allowed.
(9) Any weld showing unconsumed tack weld(s) on the nonprocess contact surface can be rewelded per MJ-8.5-2 if the process contact
surface can be reinspected. Otherwise, it is rejected.
(10) Arc strikes on the nonprocess contact surface may be removed by mechanical polishing as long as the minimum design wall thick-
ness is not compromised.

137

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. MJ-8.5-1 Acceptable Weld Profiles for Tube-Attachment Fillet Welds

138

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Beadless Welds
T
Wall w
thickness

Weld zone (b) Unacceptable Crack or Crevice on Inside or Outside


(a) Acceptable Beadless Weld

Tw

(c) Unacceptable Pits or Pores on Wetted Surface (d) Voids (Microbubbles) in Weld Area
[Notes (1) and (2)]

Tw

(e) Misalignment [Note (3)] (f) Unacceptable Inclusions in the Weld Zone

Tw

(g) Discoloration in Weld Area [Notes (4) and (5)] (h) Inside Diameter Concavity [Note (6)]
NOTES:
(1) Unacceptable if
(a) any single void diameter is > 10% wall thickness, Tw, or
(b) the total for all void diameters in a cross-sectional view is > 10% wall thickness, Tw
(2) A few small voids are acceptable and are usually localized in the center of the weld zone.
(3) Unacceptable if misalignment is > 10% wall thickness, Tw. Note that misalignment is controlled on the O.D. and is based on allowable
O.D. dimensions and tolerances of fittings and piping. The owner/user is cautioned that this can result in greater I.D. misalignment
because this also takes into consideration the wall thickness dimensions and tolerances of fittings and piping. However, there are no
specified I.D. misalignment acceptance criteria.
(4) Slight discoloration is normal and acceptable (straw color).
(5) Dark color is unacceptable (brownish).
(6) Unacceptable if > 10% wall thickness, Tw.

139

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Part SF
Process Contact Surface Finishes

SF-1 PURPOSE AND SCOPE shown in Table SF-2.2-2 in addition to those shown in
Table SF-2.2-1.
The purpose of this Part is to provide process contact
Visual examination shall be performed in accordance
surface finish acceptance criteria for metallic and poly-
with examination requirements in the BPV Code,
meric materials.
Section V, Article 9, Visual Examination. The same tech-
niques shall be used for either examinations or
SF-2 METALLIC APPLICATIONS inspections.
SF-2.1 Applicable Systems
SF-2.4 Surface Condition
This Part shall be applicable to all systems designated
Process contact surfaces shall be finished using
by the owner/user or representative thereof.
mechanical polishing, cold working, machining, passiv-
Process contact surface requirements shall apply to
ation, or electropolishing processes in conformance with
all accessible and inaccessible areas of the systems that
applicable sections of this Part. When required by the
directly or indirectly come in contact with the designated
owner/user, the electropolishing or passivation contrac-
product.
tors shall qualify their procedures in accordance with
These systems shall include, but are not limited to,
the appropriate appendices as referenced in this Part.
one or more of the following:
All surfaces shall be clean, and surface roughness values
(a) USP Water-for-Injection (WFI)
shall be in accordance with Table SF-2.4-1. Cleanliness
(b) USP Purified Water
applies to finished components/equipment as produced
(c) USP Pure Steam and packaged by the manufacturer. Subsequent ship-
(d) other product/process contact surface systems ping, storage, handling, and/or installation may affect
SF-2.2 Acceptance Criteria the cleanliness, and it will become a contractual issue
between owner/user and manufacturer/service
Acceptance criteria, for common austenitic stainless provider.
steels as per Table MM-2.1-1, are listed in Tables SF-2.2-1
and SF-2.2-2. Acceptance criteria for other alloys as SF-2.5 Electropolishing Procedure Qualification
described in Part MM may differ and should be mutually
agreed upon by both the owner/user and supplier prior Electropolishing service providers shall maintain and
to ordering material. Visual comparison charts or sam- implement a quality assurance/control program for
ples may be used to define acceptable and/or unaccept- their electropolishing procedures. They shall also qualify
able process contact surfaces. their electropolishing method(s) in accordance with a
written procedure. This procedure shall specify the
SF-2.3 Examination Techniques Employed in the acceptable ranges of the electropolishing essential
Classification of Process Contact Surface variables.
Finishes Nonmandatory Appendix H, Electropolishing
Process contact surface finish examinations shall be Procedure Qualification, has been provided as a guide.
made by one or more of the following methods: Flash electropolishing shall not be acceptable. Spot
(a) visual examination electropolishing shall be acceptable if it meets the
(1) direct visual examination requirements in this section.
(2) indirect visual examination (e.g., borescopes,
mirrors)
SF-2.6 Passivation Procedure
(b) liquid penetrant testing Passivation for this Part shall be limited to newly
(c) surface roughness measurement device installed or newly modified sections of systems and
(profilometer) components. Passivation shall be performed in accor-
Acceptance criteria for metallic process contact sur- dance with an approved quality assurance/control pro-
face finishes are shown in Table SF-2.2-1. gram. The passivation method(s) including procedures
Acceptance criteria for electropolished metallic pro- for initial water flushing, chemical cleaning and degreas-
cess contact surface finishes shall meet requirements ing, passivation, and final rinse(s) shall be qualified in

140

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table SF-2.2-1 Acceptance Criteria for Metallic Process Contact Surface


Finishes
Anomaly or Indication Acceptance Criteria
Pits If diameter <0.020 in. (0.51 mm) and bottom is shiny
[Notes (1) and (2)]. Pits <0.003 in. (0.08 mm) diameter
are irrelevant and acceptable.

Cluster of pits No more than 4 pits per each 0.5 in. (13 mm) 0.5 in.
(13 mm) inspection window. The cumulative total diameter
of all relevant pits shall not exceed 0.040 in. (1.02 mm)

Dents None accepted [Note (3)].


Finishing marks If Ra max. is met.
Welds Welds used in the as-welded condition shall meet the
requirements of MJ-8.
Welds finished afterwelding shall be flush with the base
metal, and concavity and convexity shall meet the
requirements of MJ-8. Such finishing shall meet the
Ra requirements of Table SF-2.4-1.

Nicks None accepted.


Scratches For tubing, if cumulative length is <12.0 in. (305 mm) per
20 ft (6.1 m) tube length or prorated and if depth is
<0.003 in. (0.08 mm).
For fittings, valves, and other process components, if
cumulative length is <0.25 in. (6.4 mm), depth <0.003 in.
(0.08 mm), and Ra max. is met.
For vessels, if length <0.50 in. (13 mm) at 0.003 in.
(0.08 mm) depth and if <3 per inspection
window [Note (4)].

Surface cracks None accepted.

Surface inclusions If Ra max. is met.


Surface residuals None accepted, visual inspection
Surface roughness (Ra) See Table SF-2.4-1.

Weld slag For tubing, up to 3 per 20 ft (6.1 m) length or prorated, if


<75% of the width of the weld bead.
For fittings, valves, vessels, and other process components,
none accepted (as welded shall meet the requirements of
MJ-8 and Table MJ-8.4-1).
Porosity None open to the surface.
Buffing None accepted.

GENERAL NOTE: This table covers surface finishes that are mechanically polished or any other finishing
method that meets the Ra max.
NOTES:
(1) Black bottom pit of any depth is not acceptable.
(2) Pits in super-austenitic and nickel alloys may exceed this value. Acceptance criteria for pit size
shall be established by agreement between owner/user and supplier. All other pit criteria remain
the same.
(3) For vessels, dents in the area covered by and resulting from welding dimple heat transfer jackets
are acceptable.
(4) An inspection window is defined as an area 4 in. 4 in. (100 mm 100 mm).

141

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table SF-2.2-2 Additional Acceptance Criteria for Electropolished Metallic


Process Contact Surface Finishes
Anomaly or Indication Acceptance Criteria
Blistering None accepted
Buffing None accepted
Cloudiness None accepted
End grain effect Acceptable if Ra max. is met
Fixture marks Acceptable if electropolished
Haze None accepted
Orange peel Acceptable if Ra max. is met
Stringer indication Acceptable if Ra max. is met
Weld whitening Acceptable if Ra max. is met
Variance in luster Acceptable if Ra max. is met

Table SF-2.4-1 Ra Readings for Metallic Process


Contact Surfaces
Mechanically Polished [Note (1)]

Surface Ra Max.
Designation in. m

SF0 No finish requirement No finish requirement


SF1 20 0.51
SF2 25 0.64
SF3 30 0.76
Mechanically Polished [Note (1)] and
Electropolished
Ra Max.
in. m
SF4 15 0.38
SF5 20 0.51
SF6 25 0.64

GENERAL NOTES:
(a) All Ra readings are to be in accordance with ASME B46.1.
(b) All Ra readings are taken across the lay, wherever possible.
(c) No single Ra reading shall exceed the Ra max. value in this
table.
(d) Other Ra readings are available if agreed upon between
owner/user and supplier, not to exceed values in this table.
NOTE:
(1) Or any other finishing method that meets the Ra max.

accordance with a written procedure and documenta- to ensure the presence of a passive layer shall be agreed
tion package. This procedure shall specify the acceptable to between the owner/user and contractor.
ranges of the passivation essential variables.
Nonmandatory Appendix E, Passivation Procedure SF-2.7 Normative References
Qualification, has been provided as a guide to passiv-
ation practices and evaluation of passivated surfaces. The following standards contain provisions that,
Spot passivation is permitted. The pickling process shall through reference, specify terms, definitions, and
not be accepted as a substitute for passivation. There parameters for the determination of surface texture
is no universally accepted nondestructive test for the (roughness, waviness, and primary profile) by profiling
presence of a passive layer. methods.
For passivated process contact surfaces, the accept-
ance criteria in Table SF-2.6-1 apply in addition to ASME B46.1, Surface Texture (Surface Roughness,
Table SF-2.2-1 and/or Table SF-2.2-2, as applicable. Tests Waviness, and Lay)

142

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table SF-2.6-1 Acceptance Criteria for Metallic Passivated Process Contact


Surface Finishes
Anomaly or Indication Acceptance Criteria

Surface particles No particles observed under visual inspection, without


magnification, and using adequate room lighting.
Stains None accepted (weld discoloration to comply with Part
MJ, Tables MJ-8.2-1 through MJ-8.5-1).
Visible construction debris None accepted

Visible oils or organic compounds None accepted

GENERAL NOTES:
(a) Surface condition must meet Tables SF-2.2-1 and/or SF-2.2-2, as applicable.
(b) Additional tests/acceptance criteria may be selected from Table E-5-1, Test Matrix for Evaluation of
Cleaned and/or Passivated Surfaces in Nonmandatory Appendix E, Passivation Procedure
Qualification.

Publisher: The American Society of Mechanical and/or long-term operation of the system.
Engineers (ASME), Two Park Avenue, New York, NY Nonmandatory Appendix D, Rouge and Stainless Steel,
10016-5990; Order Department: 22 Law Drive, P.O. provides the methods to measure rouge in a system in
Box 2900, Fairfield, NJ 07007-2900 (www.asme.org) both the process solution and on the actual process con-
tact surface. It also suggests various fabrication and
ISO 3274, Geometrical Product Specifications (GPS)
operation practices to minimize rouge formation and
Surface texture: Profile method Nominal character-
methods/techniques for its remediation. See definition
istics of contact (stylus) instruments
of rouge in GR-8.
ISO 4287, Geometrical Product Specifications (GPS)
For more information, refer to the ISPE Water and
Surface texture: Profile method Terms, definitions
Steam Systems Baseline Pharmaceutical Engineering
and surface texture parameters
Guide.
ISO 4288, Geometrical Product Specifications (GPS)
Surface texture: Profile method Rules and proce-
dures for the assessment of surface texture SF-3 POLYMERIC APPLICATIONS
ISO 11562, Geometrical Product Specifications (GPS)
Surface texture: Profile method Metrological char- SF-3.1 Applicable Systems
acteristics of phase correct filters This section shall be applicable to all systems desig-
Publisher: International Organization for nated by the owner/user or representative thereof.
Standardization (ISO) Central Secretariat, 1, ch. de la Process contact surface requirements shall apply to
Voie-Creuse, Case postale 56, CH-1211, Gene`ve 20, all accessible and inaccessible areas of the systems that
Switzerland/Suisse (www.iso.org) directly or indirectly come in contact with the designated
product.
SF-2.8 Rouge and Stainless Steel These systems shall include process systems and clean
Rouge is a naturally occurring phenomenon in utilities.
existing stainless steel high purity process systems
SF-3.2 Materials
(including water or pure steam). The degree to which
it forms depends upon The preferred materials of construction for these sys-
(a) the stainless steel material used for each compo- tems shall be as described in PM-2, Materials.
nent within the system
(b) how the system was fabricated (e.g., welding, sur-
SF-3.3 Examination Techniques Employed in the
face finish, passivation treatment)
Classification of Process Contact Surface
Finishes
(c) what process conditions the system is exposed
to (e.g., water purity, process chemicals, temperatures, Process contact surface finish inspections shall be
pressures, mechanical stresses, flow velocities, and con- made by one or more of the following methods:
centration of dissolved gases, such as oxygen or carbon (a) visual inspection
dioxide) (1) direct visual examination (e.g., illumination
(d) how the system is maintained through pipe/tube wall)
The presence of rouge in a system needs to be evalu- (2) indirect visual examination (e.g., borescopes,
ated against its potential to affect the product, process, mirrors)

143

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Table SF-3.3-1 Acceptance Criteria for Polymeric Process


Contact Surface Finishes
Anomaly or Indication Acceptance Criteria

Scratches For rigid tubing/piping, if cumulative length is <12.0 in. (305 mm)
per 20 ft (6.1 m) tube/pipe length or prorated and if depth
<0.003 in. (0.08 mm).
For other process components, surface finish must be agreed upon
by supplier and owner/user.
Surface cracks None accepted

Surface inclusions None accepted


Surface roughness, Ra See Table SF-3.4-1.

GENERAL NOTE: All process contact surface finishes shall be defined by the owner/user and supplier
using the criteria described in SF-1, Purpose and Scope.

Table SF-3.4-1 Ra Readings for Polymeric


Process Contact Surfaces
Surface Ra max.
Designation in. m

SFP0 No finish requirement No finish requirement


SFP1 15 0.38
SFP2 25 0.64
SFP3 30 0.76
SFP4 40 1.01
SFP5 50 1.27
SFP6 60 1.52

GENERAL NOTES:
(a) No single Ra reading shall exceed the Ra max. value in this
table.
(b) Other Ra readings are available if agreed upon between owner/
user and supplier, not to exceed values in this table.

(b) surface roughness measurement device: profilo- (1) as molded


meter or other surface measurement devices (2) as extruded
Acceptance criteria of polymeric process contact sur- (3) as machined
face finishes are shown in Table SF-3.3-1. (4) as fabricated from molded, extruded, or
Visual examination shall be performed under ade- machined components
quate room lighting. Additional lighting shall be used (b) sheet, rod, and block
when appropriate to illuminate blind or darkened areas (1) as molded
and to clarify questionable areas. (2) as extruded
The same techniques shall be used for either examina- (3) as machined after molding or extrusion
tions or inspections. These are generally utilized terms and may not be
applicable in all cases. The final criteria shall be deter-
SF-3.4 Surface Condition
mined by the Ra values shown in Table SF-3.4-1.
The following surface finishes of polymeric materials
are available:
(a) piping/tubing and fittings

144

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Part SG
Sealing Components

SG-1 PURPOSE AND SCOPE standards [e.g., ISO 2852, DIN 11864 (-1, -2, -3, O-rings)].
(See Figs. SG-2.2.2-3 and SG-2.2.2-4.)
The purpose of this Part is to provide the requirements
Other hygienic unions and cross-sectional geometries
for the sealing components of seals, valves, and fittings
shall meet all of the requirements of this Standard, except
used in the bioprocessing industry. These sealing compo-
for the ferrule dimensions.
nents create or maintain process boundaries between
Nonhygienic connections shown in Fig. SG-2.2.2-5 are
system components and/or subassemblies to ensure
not recommended (e.g., threaded fittings exposed to pro-
process system integrity. This Part defines the design of
cess fluid).
seals, valves, and fittings. This Part also enables equip-
ment manufacturers, system designers, and owners/ SG-2.2.3 O-Ring Seals. An O-ring is a ring seal with
users to specify the required seal, valve, and fitting type a circular cross section (a toroid), designed to be seated
and performance for specific applications. It is not the in a groove and compressed during assembly. O-rings
intent of this Part to inhibit the development or use of are most often used as static seals. These are used exten-
new technologies. sively in hygienic applications and can seal both radially
and axially opposed faces. Common static O-ring appli-
cations include sealing fasteners, shaft couplings, and
SG-2 SEALING COMPONENT TYPES pump and filtration components.
SG-2.1 General Other ring seal geometries of varying cross sections
(e.g., manway gaskets) may be used in hygienic applica-
Sealing components used in bioprocessing equipment tions. However, significant differences may exist in their
take a variety of forms based on their function within performance (e.g., pressure and cleanability) and should
the system and the process boundaries to the atmo- be evaluated accordingly.
sphere and other systems, which they must maintain. Examples of O-ring industry standards include
The following sections define the main types of sealing SAE AS568, Aerospace Size Standard for O-Rings and
components and their acceptability for use in the bio- ISO 3601, Fluid Power Systems O-Rings.
processing industry. For this section, seals are divided For use in bioprocessing applications, O-rings and
into static and dynamic seals. All acceptable seals shall their mating surfaces shall meet the requirements of this
meet the design criteria, materials, and performance Standard.
characteristics contained in this Standard.
SG-2.2.4 Other Static Seals. Other static seals used
SG-2.2 Static Seals in bioprocessing applications shall meet the require-
ments of this Standard (e.g., flat gaskets, L-cups, U-cups,
SG-2.2.1 General. A static seal is characterized by stoppers, septums, and bioseals).
the absence of relative motion between sealing surfaces, Inflatable static seals are static seals where gas is sup-
or between the sealing surface and a mating surface, plied to the inner part of the seal, providing a pillow
after initial installation. Small amounts of movement barrier between the process and the atmosphere. They
that might be caused by thermal expansion, vibration, are commonly used in large process components, and
bolt stretch, or seal response to fluid pressure, do not in connections, to support structures.
alter the static definition.
SG-2.3 Dynamic Seals
SG-2.2.2 Hygienic Unions. Hygienic unions provide
connections between process components (e.g., pipe fit- A dynamic seal is characterized by the movement
tings, tank fittings, instruments, and hoses) to ensure of the seal surface and a mating surface, after initial
the process integrity is maintained. They include seals installation.
between two ferrules.
SG-2.3.1 Valves
The geometry of the most common hygienic union
is governed by Table DT-7-1, and is shown in SG-2.3.1.1 General. Valves are process compo-
Figs. SG-2.2.2-1 and SG-2.2.2-2 of this Standard. Other nents that provide dynamic seals within the process.
geometries for the opposing ferrules are also used in They also provide seals between the process and the
the industry, and are controlled by relevant industry atmosphere.

145

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SG-2.2.2-1 Hygienic Union per Table DT-7-1

See Fig. SG-4.2-1


See Fig. SG-4.2-1 intrusion/recess
intrusion/recess

(a) Typical Hygienic Clamp Union (b) Typical Hygienic Clamp Union (c) Typical Hygienic Clamp Union
1 in. and Smaller (Type A) per Table DT-7-1 1 in. (Type B) per Table DT-7-1 1.5 in. and Larger (Type B) per Table DT-7-1
(Accepted) (Accepted) (Accepted)

Fig. SG-2.2.2-2 Hygienic Clamp Union per Table DT-7-1


Symmetric ferrules

Gasket

Clamp

(Accepted)

146

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SG-2.2.2-3 Hygienic Union per DIN 11864

(Accepted)

Fig. SG-2.2.2-4 Hygienic Clamp Union per DIN 11864


Asymmetric ferrules

O-ring

Clamp

(Accepted)

147

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SG-2.2.2-5 Nonhygienic Connections


(Not Accepted For Hygienic Service)

Actual sealing point


Crevice area

Tubing

Fitting or Valve
(a) Roll-On Fitting
(b) Compression Fitting

Major crevice area

Rough interior
finish

(c) Threaded Joint Clearance at bolt Gasket not positively


holes may permit located may slip
misalignment and cause large crevice

(d) Flanged Joint

(e) Bevel Seat

Fitting Crevice area


Tubing or pipe
Difficult to clean

(f) Nozzle Detail

(g) Socket Joint

148

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SG-2.3.1.2-1 Weir Valves

(a) Weir Diaphragm Valve (b) Weir Diaphragm Tank Bottom Valve

(14) SG-2.3.1.2 Diaphragm Valves A dynamic seal is used on a rotary stem (see
(a) Weir Diaphragm Valve, Weir Diaphragm Tank Bottom Fig. SG-2.3.1.3-1).
Valve. The diaphragm seal is a flexible membrane that SG-2.3.1.4 Rising Stem Single, Double Seat Mix
forms positive closure when compressed against the Proof, Needle Valves. Plug(s) are used to close flow
weir (see Fig. SG-2.3.1.2-1). The diaphragm is a product/ against seat(s). Dynamic seal(s) are used on linear
process contact seal creating both static (atmospheric) stem(s). Static seals are used between body components
and dynamic (differential) seals. (see Fig. SG-2.3.1.4-1).
(b) Radial Diaphragm Valve, Radial Diaphragm Tank
Bottom Valve. The diaphragm seal is a flexible membrane SG-2.3.1.5 Butterfly Valves. The seat/seal creates
that forms positive closure when compressed against a dynamic seal when the disc is rotated into the closed
a radial seat (see Fig. SG-2.3.1.2-2). The diaphragm is position (see Fig. SG-2.3.1.5-1). The seat/seal also forms
typically a product/process contact seal creating both the primary stem seal to prevent leakage through stem
static (atmospheric) and dynamic (differential) seals. journal.
However, in some designs static seals may be used SG-2.3.1.6 Thermostatic Steam Trap. The valve
between body components. seat is closed by a plug attached to a dynamic bellows
(c) Weirless Diaphragm Valve. The diaphragm seal is a seal. The body cavity for a serviceable steam trap is
flexible membrane that modulates flow across a weirless typically sealed by a static seal (see Fig. SD-3.1.2-1).
valve body and also forms positive closure when
compressed against the weirless valve body (see SG-2.3.1.7 Back Pressure Control Valve. A non-
Fig. SG-2.3.1.2-3). The diaphragm is a product contact sliding seal (such as a diaphragm) is used to seal a linear
seal creating both atmospheric and differential seals. stem. For closure, the valve may use a soft seal such as
(d) Linear Control Valve. A sliding seal (such as an an O-ring or diaphragm, or a metal-to-metal seal/seat
O-ring) or nonsliding seal (such as a diaphragm) is used (see Fig. SG-2.3.1.7-1). To regulate the flow, the operating
to seal a linear stem (see Fig. SG-2.3.1.2-4). For closure, diaphragm responds to pressure to control the regulat-
the linear control valve may use a soft seal such as an ing plug and functions as a static seal around its
O-ring or diaphragm, or a metal-to-metal seal/seat. perimeter.
(e) Regulator Valve. A control diaphragm is a flexible SG-2.3.1.8 Pinch Valve. Pinch valves use a flexible
membrane that typically is used as a pressure barrier tube or sleeve that forms a differential seal when closed
and also forms a static seal to the atmosphere. A plug (see Fig. SG-2.3.1.8-1).
type dynamic seal may be used for closure. Static seals
SG-2.3.1.9 Check, Pressure Relief, and Safety (14)
are used between body components. To regulate the
Pressure Relief Valves
flow, the operating diaphragm responds to pressure to
(a) A check valve is a unidirectional flow device (see
control the regulating plug and functions as a static seal
Fig. SG-2.3.1.9-1). When the application requires draina-
around its perimeter (see Fig. SG-2.3.1.2-5).
bility, a check valve may include provisions for drainage,
SG-2.3.1.3 Ball Valve, Ball Tank Bottom Valve. The such as flats, drain holes, or a drain port.
seat/seal functions as a dynamic seal against the rotating (b) A pressure relief valve is a type of valve that
ball. Static seals are used between body components. relieves pressure in a system in order to protect against

149

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SG-2.3.1.2-2 Radial Valves

(a) Radial Diaphragm Tank Bottom Valve (b) Radial Diaphragm Valve

(c) Bellows Radial Diaphragm Tank Bottom Valve (d) In-Line Radial Diaphragm Valve

Fig. SG-2.3.1.2-3 Weirless Diaphragm Valve

150

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SG-2.3.1.2-4 Linear Control Valves

(a) Linear Control Valve (b) Linear Control Valve (c) Linear Control Valve
With O-Ring Seal With Elastomer Diaphragm Seal With Metallic Diaphragm Seal

Fig. SG-2.3.1.2-5 Regulator Valve

151

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SG-2.3.1.3-1 Ball Valves

(a) Ball Tank Bottom Valve (b) Ball Valve

Fig. SG-2.3.1.4-1 Rising Stem Single, Double Seat Mix Proof, and Needle Valves

(a) Rising Stem Single Valve (b) Double Seat Mix Proof Valve (c) Needle Valve

152

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SG-2.3.1.5-1 Butterfly Valve

Fig. SG-2.3.1.7-1 Back Pressure Control Valve

Fig. SG-2.3.1.8-1 Pinch Valve

(a) Pinch Valve Open (b) Pinch Valve Closed

153

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

(14) Fig. SG-2.3.1.9-1 Pressure Relief and Check Valves

Flow
Open (Flow) Position Closed (Check) Position

(a) Spring-Type Check Valve

Flow

Open (Flow) Position Closed (Check) Position

(b) Poppet-Type Check Valve (Vertical Configuration) [Note (1)]

Normal Flow Direction

Open (Flow) Position Closed (Check) Position

(c) Poppet-Type Check Valve (Horizontal Configuration) [Note (1)]

NOTE:
(1) Grey color represents back flow blocked by the poppet.

154

Copyright c 2014 by the American Society of Mechanical Engineers.


No reproduction may be made of this material without written consent of ASME.
ASME BPE-2014

Fig. SG-2.3.1.10-1 Plug Valve

mechanical damage of equipment. An override device


Fig. SG-2.3.2.2-1 Single Mechanical Seal
may be used to allow flow through the valve for the
purpose of cleaning. Pressure relief valves allow
bypassing of the over-pressured fluid back into the pro- Rotating face
cess line or a safe location (e.g., from a pump discharge
back to the pump suction).
(c) A safety pressure relief valve is a type of valve
Stationary face
used to relieve the pressure in a system or vessel, caused
by a process upset, instrument or equipment failure, or Process side
fire. Its purpose is to protect people and equipment
from a potential explosion or leaks. The flow is one- Atmospheric side
directional. In case of over-pressure, the fluid is dis-
charged to a safe location outside the pressurized
system.
SG-2.3.1.10 Plug Valves. The plug-body valve or
plug-seal valve functions as a dynamic seal against the
rotating plug (see Fig. SG-2.3.1.10-1). (d) Single Mechanical Seals for Pumps