Design Qualification

CIP SKID & DISTRIBUTION PIPING (VEG BLENDER FLAVOURS

POWDER)
DOC NO: DQ/19/M20017/CSVB; REV.00; DATED 13.08.2019
Client: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA
PVT LTD.,NELLORE

Praj HiPurity Systems Limited

1181/82, Solitaire Corporate Park, 8th Floor,
Building 11, Andheri -Ghatkopar Link Road,
Andheri (East), Mumbai – 400 093
Tel: + 91 22 40888444
www.prajhipurity.net

Innovate • Integrate • Deliver

 DESIGN QUALIFICATION
TITLE : CIP SKID & DISTRIBUTION PIPING (VEG BLENDER FLAVOURS
POWDER)
CLIENT: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT
LTD.,NELLORE
Doc. No.: DQ/19/M20017/CSVB Rev. No. : 00 Page No.: 1 of 11

DESIGN QUALIFICATION APPROVAL

SYSTEM SUPPLIER: M/s. PRAJ HIPURITY SYSTEMS LTD.

Prepared Department: Name: Nawaf Basheer Sign & Date:

By HiPurity-Engg
Designation: Engineer

Reviewed Department: Name: Vikram Patil Sign & Date:

By HiPurity-Engg
Designation: Engineer

Reviewed Department: Name: Alan Joshy Sign & Date:

By HiPurity-Engg
Designation: Asst. Manager

Approved Department: Name: Sankhajeet Kole Sign & Date:

By HiPurity-Engg Designation: GM

CLIENT: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT LTD.

Reviewed Department: Name: Sign & Date:

By Designation:

Reviewed Department: Name: Sign & Date:

By Designation:

Approved Department: Name: Sign & Date:

By Designation:

Department: Name: Sign & Date:

Authorized
by
Designation:

Praj HiPurity Systems Ltd ENGG/F/DQ01REV:03/27.11.2014

 DESIGN QUALIFICATION
TITLE : CIP SKID & DISTRIBUTION PIPING (VEG BLENDER FLAVOURS
POWDER)
CLIENT: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT
LTD.,NELLORE
Doc. No.: DQ/19/M20017/CSVB Rev. No. : 00 Page No.: 2 of 11

INDEX

1.ABBREVIATIONS...............................................................................................................................3
2.INTRODUCTION............................................................................................................................... 4
3.OBJECTIVE....................................................................................................................................... 4
4.SCOPE............................................................................................................................................... 4
5.STANDARDS AND GUIDELINES....................................................................................................... 5
6.RESPONSIBILITY.............................................................................................................................. 5
6.1.M/s. PRAJ HIPURITY SYSTEMS LTD.:....................................................................................... 5

6.2.M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT LTD......................................6

7.SYSTEM DESCRIPTION.................................................................................................................... 6
7.1.DESIGN OVERVIEW...................................................................................................................... 6
8.UTILITY REQUIREMENT SPECIFICATION.......................................................................................7
9.TECHNICAL SPECIFICATION...........................................................................................................7
10.EQUIPMENT QUALIFICATION PLAN.............................................................................................7
11.FAT - FACTORY ACCEPTANCE TEST...........................................................................................8
12.SAT - SITE ACCEPTANCE TEST (IQ/OQ - INSTALLATION & OPERATIONAL QUALIFICATION)
.............................................................................................................................................................. 9
13.SUPPORTING DOCUMENTS........................................................................................................ 10
14.ANNEXURES................................................................................................................................. 11
15.REVISION HISTORY..................................................................................................................... 11

Praj HiPurity Systems Ltd ENGG/F/DQ01REV:03/27.11.2014

 DESIGN QUALIFICATION
TITLE : CIP SKID & DISTRIBUTION PIPING (VEG BLENDER FLAVOURS
POWDER)
CLIENT: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT
LTD.,NELLORE
Doc. No.: DQ/19/M20017/CSVB Rev. No. : 00 Page No.: 3 of 11

1. ABBREVIATIONS

SR.NO ABBREVIATION DESCRIPTION

1. cGMP current Good Manufacturing Practices

2. DQ Design Qualification

3. EP Electro Polished

4. IQ Installation Qualification

5. kg / cm2 Kilogram per Centimeter Square

6. MOC Material of Construction

7. g/L Grams per Liter

8. SS Stainless Steel

9. GA General Arrangement

10. WHO World Health Organization

11. P&ID Piping & Instrumentation Drawing

12. PHS Praj HiPurity Systems Limited

13. Ra Roughness Average

14. URS User Requirement Specification

15. FAT Factory Acceptance Test

16. F.V. Full Vacuum

17. PW Purified Water

18. mm Millimeter

19. µ Micron

Praj HiPurity Systems Ltd ENGG/F/DQ01REV:03/27.11.2014

 DESIGN QUALIFICATION
TITLE : CIP SKID & DISTRIBUTION PIPING (VEG BLENDER FLAVOURS
POWDER)
CLIENT: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT
LTD.,NELLORE
Doc. No.: DQ/19/M20017/CSVB Rev. No. : 00 Page No.: 4 of 11

2. INTRODUCTION

This Design Qualification document prepared by Praj HiPurity Systems (PHS),

defines the complete design of “CIP Skid & distribution piping for Veg Blender
Flavours Powder” to be supplied & installed in the facility of M/s. International
flavours & fragrances Pvt Ltd.,Nellore.This DQ will act as a basic reference
document for the designing, manufacturing & qualification activity. The DQ is
prepared for designing the equipment/system in compliance with the design data &
agreed technical specifications between M/s. International flavours & fragrances Pvt
Ltd. and PHS, Mumbai.

3. OBJECTIVE

The objective of this DQ is to ensure that the design requirements of the “CIP
Skid & distribution piping for Veg Blender Flavours Powder” are considered and the
design is in compliance with current Good Manufacturing Practices and Good
Engineering Practices. This DQ is intended to cover the minimum requirements to be
meet by the system consisting of vessel along with its associated components.

4. SCOPE

The scope of this system will be limited to design/supply/installation/

commissioning/qualification and handover of the equipment within the designated
area.

Praj HiPurity Systems Ltd ENGG/F/DQ01REV:03/27.11.2014

 DESIGN QUALIFICATION
TITLE : CIP SKID & DISTRIBUTION PIPING (VEG BLENDER FLAVOURS
POWDER)
CLIENT: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT
LTD.,NELLORE
Doc. No.: DQ/19/M20017/CSVB Rev. No. : 00 Page No.: 5 of 11

5. STANDARDS AND GUIDELINES

The following standards shall be the basis for the design and manufacturing of the
above mentioned equipment:
 WHO Guidelines for Good Manufacturing Practice.
 US FDA Part 211-Current Good Manufacturing Practice for Finished
Pharmaceuticals.
 ISPE Baseline Guide Volume 5: Commissioning and Qualification.

6. RESPONSIBILITY

In order to achieve the above objective for the complete system, following will
be the responsibility of M/s. PHS and M/s. International flavours & fragrances Pvt Ltd.

6.1 M/s. PRAJ HIPURITY SYSTEMS LTD.:

 The complete system shall be designed by M/s. Praj HiPurity Systems as per
the agreed technical specifications and offer submitted.
 P&ID & technical specification will be prepared and submitted to M/s.
International flavours & fragrances Pvt Ltd. as per requirements.
 MOC certificates / compliance certificates for the various items used for the
system along with calibration certificates for instruments will be provided. If
the calibration of instruments expires before hand over to client, then PHS
shall calibrate the instrument and provide in-house calibration certificate.
 Factory Acceptance Test, Installation qualification and operational
qualification will be submitted & performed as part of the commissioning and
qualification documents for the complete system after the approval of Design
Qualification.

Praj HiPurity Systems Ltd ENGG/F/DQ01REV:03/27.11.2014

 DESIGN QUALIFICATION
TITLE : CIP SKID & DISTRIBUTION PIPING (VEG BLENDER FLAVOURS
POWDER)
CLIENT: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT
LTD.,NELLORE
Doc. No.: DQ/19/M20017/CSVB Rev. No. : 00 Page No.: 6 of 11

6.2 M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT LTD.

 To check and verify all the documents submitted as above are in line with
agreed specifications and scope.
 M/s. International flavours & fragrances Pvt Ltd. will approve all the
documents to signify that PHS has complied with their commitment.
 To review and approve the Factory Acceptance Test Protocol, Installation
qualification and operational qualification protocols.
 To provide the required utilities for equipment operations, necessary site
clearance and complete the site activities covered in the scope of M/s.
International flavours & fragrances Pvt Ltd.
 Ensures that all the utilities and material required (if any) for the
commissioning of system as specified by M/s. Praj HiPurity Systems Limited in
design qualification and other documents are made available at site.

7. SYSTEM DESCRIPTION

7.1 DESIGN OVERVIEW

The CIP Skid system shall be as per the PID.

 A Centrifugal pump shall be provided for re-circulation purpose.
 Dosing Pump shall be provided for CIP Operations.Dosing bottle and its
accessories shall be in M/s. International flavours & fragrances Pvt Ltd Scope.
 All Piping's and fittings shall be of BS4825 standards. Wheel shall be antistatic
with lockable type
 The skid shall be facilitated with caster wheel for mobility.
 All process contact parts are made from SS316L and non-contact parts are
made of SS304.
 The system is equipped with necessary components and instruments as per
process requirement.

Praj HiPurity Systems Ltd ENGG/F/DQ01REV:03/27.11.2014

 DESIGN QUALIFICATION
TITLE : CIP SKID & DISTRIBUTION PIPING (VEG BLENDER FLAVOURS
POWDER)
CLIENT: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT
LTD.,NELLORE Praj need to take tapping
Doc. No.: DQ/19/M20017/CSVB Rev. No. : 00 Page
for No.: 7 of&11
HPW Line CA line
Maximum available 4 from nearest available
8. UTILITY REQUIREMENT SPECIFICATION bar(g) header

UTILITY REQUIRED PARAMETER END CONNECTION

Hot potable water supply 3.5 to 4.5 bar (g) 2 ” OD TC End

Compressed air 6.0 to 7.0 bar (g) ½ ” OD TC End

Maximum available 6
CONTROL PANEL POWER SUPPLY bar(g)

3-Phase / 50 Hz Power supply with

415V AC, 50 Hz, PE AC
Neutral & Earthing

1-Phase / 50 Hz Power supply with

230V AC
Earthing

9. TECHNICAL SPECIFICATION

Technical specification of Components & Instruments is attached as an annexure

document with the DQ.

10. EQUIPMENT QUALIFICATION PLAN

Once sign-off approvals on Design qualification are in place, Factory Acceptance

Test (FAT) protocol shall be shared to client for approvals. FAT will be performed at
PHS factory according to this protocol. Any changes in system during FAT apart from
Design qualification will be noted /addressed in FAT protocol deviation list.
After successful FAT/Dispatch of System, Installation Qualification/Operational
Qualification (IQ/OQ) Protocol shall be shared to client for approvals. Once
Installation is finished at site, IQ will be executed. Post successful outcome of IQ, OQ
shall be performed and commission certificate is issued. Then system is ready for PQ
which in client scope.

Praj HiPurity Systems Ltd ENGG/F/DQ01REV:03/27.11.2014

 DESIGN QUALIFICATION
TITLE : CIP SKID & DISTRIBUTION PIPING (VEG BLENDER FLAVOURS
POWDER)
CLIENT: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT
LTD.,NELLORE
Doc. No.: DQ/19/M20017/CSVB Rev. No. : 00 Page No.: 8 of 11

11. FAT - FACTORY ACCEPTANCE TEST

This test will certify that the manufacturing of the equipment has been carried
out according to the Design specification and intended operation. Upon successful
execution of FAT, the system shall be dispatched to client site.
Following are the main tests offered during FAT and shall be performed during
FAT as applicable. Detailed test shall be mentioned in FAT Protocol.
TEST PURPOSE
SYSTEM DOCUMENTATION CHECK
Documents related to all components MOC, Surface finish
and relevant certificates will be verified for DQ
compliance during FAT.
P&ID VERIFICATION
Components, valves and instruments shown in P & ID
should be installed correctly in accordance with the
drawing and those are marked with the correct tag no. as
per P & ID and it should be verified with approved P&ID
during FAT.
WELDING VERIFICATION

The details will be mentioned on welding reports during

FAT along with supporting documents (such as Welding
SOP, welder training certificate, welding machine
certificate, argon gas purity certificate etc.).

COMPONENT VERIFICATION
All valves, instruments and components should be located
according to final P & ID and it should be verified with
approved P&ID during FAT.

Praj HiPurity Systems Ltd ENGG/F/DQ01REV:03/27.11.2014

 DESIGN QUALIFICATION
TITLE : CIP SKID & DISTRIBUTION PIPING (VEG BLENDER FLAVOURS
POWDER)
CLIENT: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT
LTD.,NELLORE
Doc. No.: DQ/19/M20017/CSVB Rev. No. : 00 Page No.: 9 of 11

12. SAT - SITE ACCEPTANCE TEST (IQ/OQ - INSTALLATION & OPERATIONAL

QUALIFICATION)

SAT (IQ/OQ) test shall be carried out at the customer facility and then it shall
certify that the installation/operation of the equipment has been carried out
according to the Design/operational specification. When executed, this acceptance
test shall demonstrate that the system is installed & functioning as anticipated and
ready for intended use. Following tests are the part of site acceptance test and these
has to be carried out during IQ/OQ.
All other details will be described in IQ/OQ protocol. Following are the main tests
offered during IQ/OQ and shall be performed as applicable.

P&ID VERIFICATION
Components, valves and instruments shown in P & ID
should be installed correctly in accordance with the
drawing and those are marked with the correct tag no. as
per P & ID and it should be verified with approved P&ID
during IQ.

SYSTEM DOCUMENTATION CHECK

Documents related to all components MOC, Surface finish,
drawings verification and relevant certificates will be
verified for DQ compliance during IQ.
WELDING VERIFICATION
The details will be mentioned on welding reports during
SAT along with supporting documents (such as Welding
SOP, welder training certificate, welding machine
certificate).

Praj HiPurity Systems Ltd ENGG/F/DQ01REV:03/27.11.2014

 DESIGN QUALIFICATION
TITLE : CIP SKID & DISTRIBUTION PIPING (VEG BLENDER FLAVOURS
POWDER)
CLIENT: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT
LTD.,NELLORE
Doc. No.: DQ/19/M20017/CSVB Rev. No. : 00 Page No.: 10 of 11

13. SUPPORTING DOCUMENTS

IQ OQ After No of
Documents DQ FAT
(As-Built) Installation Sets

P&I Diagram    -- 1

Technical Specification
   -- 1
(Mechanical & Instrument BOM)
Calibration / test / quality /
--   -- 1
certificates of components

Welding Qualification documents --   -- 1

MOC / Surface Finish Test Report --  -- -- 1

Training Documents -- --  -- 1

Change parts list -- -- --  1

Recommended Spare Part List -- -- --  1

Commissioning report -- -- --  1
Guarantee/warrantee certificates of
-- -- --  1
instruments/components

Praj HiPurity Systems Ltd ENGG/F/DQ01REV:03/27.11.2014

 DESIGN QUALIFICATION
TITLE : CIP SKID & DISTRIBUTION PIPING (VEG BLENDER FLAVOURS
POWDER)
CLIENT: M/s. INTERNATIONAL FLAVOURS & FRAGRANCES INDIA PVT
LTD.,NELLORE
Doc. No.: DQ/19/M20017/CSVB Rev. No. : 00 Page No.: 11 of 11

14. ANNEXURES

DOCUMENT DOCUMENT NO. REV. NO. DATE

P&ID M-20017-PID-02-R1 R1 06.08.2019
Technical Specification
TS/19/M/M20017/CSVB 01 13.08.2019
(Mechanical)
Technical Specification
TS/19/I/M20017/CSVB 00 12.08.2019
(Instrumentation)

15. REVISION HISTORY

REVISION NO. DATE DONE BY DESCRIPTION

00 13.08.2019 Nawaf Basheer For Review & Approvals

Praj HiPurity Systems Ltd ENGG/F/DQ01REV:03/27.11.2014