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USER REQUIREMENTS
SPECIFICATION

SATURATED STEAM
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USER REQUIREMENTS TEMPLATE

for a SATURATED STEAM AUTOCLAVE

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SATURATED STEAM
AUTOCLAVE

August 19, 2002

NOTES for use of the User Requirements Template:

Upon completion of the template, delete this page prior to updating the Table of
Contents and printing.
1. Many areas of this template have selections or tables that have been prepared
for guidance and ease of template completion. Text in italics is intended to be
used as notes to the User and should be deleted prior to printing. Any options
and/or examples that are not applicable to the specific document being created
should be deleted as well.
2. To update the final Table of Contents, place the cursor inside the shaded area,
press the Right mouse key, and select Update Field.
3. Items that can be directly tested are identified with a

4. Where possible, the User should identify the source (e.g. studies, standards, etc.)
for the acceptable ranges of variables or other critical requirements that have
been derived.

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AUTOCLAVE

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REVISION HISTORY
Rev.

Date

Approval

Revision Summary

A1

12/10/01

A2

05/17/01

A3

05/18/01

A4

10/18/01

A5

11/12/01

A6

11/19/01

A7

12/05/01

A8

02/20/02

C1

05/20/02

M. Rivera

Format Review

C2

7/12/02

M. Casey

Validation Review

8/19/02

D.
Noteboom

Initial release issued to JETT website

Content review by Mike Casey, Ramon LeDoux, Dale

Noteboom and Marieva Rivera

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TABLE OF CONTENTS
1.0

INTRODUCTION..............................................................................................5

2.0

OVERVIEW........................................................................................................6

3.0
OPERATIONAL REQUIREMENTS...............................................................7
3.1
CAPACITY.........................................................................................................7
3.2
PROCESS REQUIREMENTS...............................................................................7
3.3
PROCESS CONTROL.........................................................................................8
3.4
FUNCTIONS.......................................................................................................8
3.5
DATA AND SECURITY.....................................................................................12
3.6
ENVIRONMENT...............................................................................................14
4.0
CONSTRAINTS...............................................................................................17
4.1
MILESTONES AND TIMELINES.......................................................................17
4.2
EQUIPMENT CONSTRAINTS...........................................................................18
4.3
COMPATIBILITY AND SUPPORT.....................................................................18
4.4
AVAILABILITY................................................................................................21
4.5
PROCEDURAL CONSTRAINTS.........................................................................21
4.6
MAINTENANCE...............................................................................................22
5.0
LIFE-CYCLE....................................................................................................23
5.1
DEVELOPMENT...............................................................................................23
5.2
TESTING..........................................................................................................23
5.3
DELIVERY.......................................................................................................24
5.4
SUPPORT.........................................................................................................25
6.0

GLOSSARY......................................................................................................26

7.0

REFERENCES.................................................................................................27

8.0

APPROVAL.......................................................................................................28

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Project No.:
Insert the unique project number associated with this particular URS.
Document No.:
Insert the Document Identification Number and Revision.
Document Description:
Insert description of document, e.g. Saturated Steam Autoclave for Sterile
Manufacturing Support.

1.0 INTRODUCTION
Note: Insert your own description and introduction. You may wish to include
your own requirements and specifics to allow the inexperienced reader,
contractors, and suppliers adequate explanation to understand the scope of the
equipment.
Describe who produced the document, under what authority, and for what
purpose.
Describe the contractual status of the document. Include or reference as an
attachment the legal paragraph that communicates purchasing terms and
conditions in this section.
Describe the relationship of this document to other documents. This is
important for equipment that is part of an integrated process or line and will
help the Supplier to understand and ask questions that may otherwise be
overlooked.
Refer to the Equipment Validation Plan that outlines the Suppliers
responsibilities is attached.
Remove any options that are not applicable for this project, if other uses will
apply list each separately.
This is to be utilized as a guide for the user to answer the majority of questions
involved in specifying the what for the equipment. Addendums may be used
to round out the requirements.

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2.0 OVERVIEW
This document encompasses the normal range of equipment operations. This
section should be expanded to provide a high level description of the system
explaining why it is required and what is required of it. Include the background,
key objectives, and the main functions and interfaces. Obviously, technology
improvements and new applications may require deviation from this template.
The User should consider including information on the following:

Use: Describe what applications the equipment/system will be used to

support. Include a brief explanation of the general functions.

For example: The autoclave will use saturated steam to sterilize product
contact and critical equipment used in the aseptic formulation and filling
of parenteral drugs. Capacity and/or Critical Attributes: Provide a brief
description of the equipment/system capacity or throughput
requirements or the critical attributes that make it desirable to acquire
the system. (Also reference any industry standards for the autoclave that
are applicable.)
For example: Provide actual chamber size needed or number of specific
components to properly size the chamber.
For example: The system must provide, at minimum, the following basic
cycles:

:
Vented Saturated Steam Cycle
1) Heating Phase
2) Exposure Phase
3) Cooling Phase
Forced Air Removal Cycle
1) Air Removal Phase
2) Heating Phase
3) Exposure Phase
4) Exhaust Phase

5) Vacuum Drying Phase

6) Vacuum Relief Phase

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3.0 OPERATIONAL REQUIREMENTS

3.1

Capacity

Describe the range or list specifically the materials,

products or equipment to be sterilized.
- Materials
- Products
- Liquids Vented or Non-Vented
Size of loads.

For example for materials: lab glassware, plastic tubing, liquids in

sealed glass containers, and liquids in sealed plastic containers.
3.2

Process Requirements
Describe the number of doors and loading and unloading requirements for
the autoclave. Define if the equipment will be floor or pit mounted and
how this will impact the loading requirements.
Describe in detail the requirements for the various steps/phases that are
required. In each phase identify the critical control requirements and
variables that are needed. For example:

Air Removal Phase (if required)

- Range of vacuum (or gravity only)
- Number of vacuum pulses.
- Time to attain vacuum
- Range of vacuum hold time.
- Vacuum level
For the following phases also provide critical control requirements and variables:
Charge Phase
Exposure Phase
Exhaust Phase

Drying Phase (if required)

Vacuum Relief Phase (if required)

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Define door seal medium (e.g. clean steam or pharmaceutical air)

requirements. Define if backup door sealing is required.
3.3

Ancillary Equipment
Describe ancillary supplied equipment; for example, loading carts/transfer
carriage requirements.

3.4

Process Control
Identify the critical process measurements such as temperature and
pressure. For each critical measurement or control device list the:

Measurement Range

Setpoint Range

Parameter Control Tolerance

If you desire special monitoring such as monitoring at specific
locations in the chamber or piping or redundant process
measurements include it in this list (for example include chamber
drain, chamber load probe (and number of probes required), chart
recorder probe). If there are standardized tests you want the supplier
to run that have given tolerances (e.g. European Norm 285) list the
applicable tests. If you are unsure what the supplier provides in their
standard models, have them provide that information to you in their
request for submittal.
Note: At a minimum, list the critical, process parameters. Consider
documenting how/where each of the parameter requirements was
determined.

3.5

Functions
3.5.1

Operation
Enter your specific operational requirements here.

Basic configurable cycles or phases required.

Number of Cycles

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Recipe capabilities. (Linking of cycles or phases

sequentially) Consider providing a recipe that the system
must be capable of running.

Operator interaction with the system. Describe your

expectations for keyboard, mouse or touch screen interaction.

The following are examples: The system shall be able to run the
multiphase cycle from start to finish with no operator interaction
required after the cycle is properly initiated.
The system shall be operated locally at the autoclave.
Describe the control system requirements in terms of manual,
semi-automatic and automatic operation. Be as specific as possible
on what the system should do.
3.5.2

Power failure/Recovery
Power Failure: Insert your specific power failure/recovery scheme
here.
For example:
In the event of a power failure, the system shall protect in the
following priority:

Personnel

Equipment

Product

In the event of a power failure the autoclave controls shall

mechanically fail to a state that places the chamber in a vented
state at atmospheric pressure.
Recovery Methods: Insert your specific power failure recovery
scheme here.
For example:

Manually re-start based on operator inputs (Operator initiates

power recovery sequence).

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Re-start based on last state before loss of power. (System

runs through power recovery sequence when operator start
signal is given)

If there is an automatic batch reporting system, the

information shall be retained in the event of a power failure
(A UPS is required for automatic batch reporting systems for
data retention).

Abort or resume cycle based on length of power failure or

temperature deviation from setpoint.

Emergency Stop
Insert your specific Emergency Stop (E-Stop) strategy and
communication scheme here.
For example: The system shall have an E-Stop mechanism
designed to stop all physical movement of the equipment
immediately. The E-Stop mechanism(s) shall be located in close
proximity to the autoclave loading and unloading doors.

3.5.4

Operator Abort
Describe the requirements for the system response to an operator
initiated cycle abort. Describe the final state the autoclave needs to
be in at the conclusion of the abort sequence.

3.5.5

Alarms and Warnings

Critical alarms - Insert your specific Critical Alarm action
scheme here.
For example: Critical Alarms shall take action automatically to
shut the equipment down and notify the operator of the
condition(s). The operator shall be required to acknowledge the
alarm before the alarm can be reset and the system restarted. Once
the alarm is reset, the operator may restart the system.
Note: For a customized equipment application, include an alarm
table, like the example that follows.
For example:

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The Equipment shall have the following critical alarms and

warnings:

Alarm or Warning

Critical

Emergency Stop
Control Platform Communication Watchdog
Control Power Fault

X
X
X

Main Instrument Air Fault

Low Steam Supply Pressure

Chamber Temperature Deviation

Jacket Temperature Deviation

Vacuum System Performance Failure

Motor Faults

CONTROL PLATFORM Battery Low Warning

Informational

The list of critical alarms in the table is not intended to be a

comprehensive list of all alarms for the system. A complete alarm
list will be developed and included in the Functional Specification
document.
For a standard equipment type application, request the supplier to
submit the complete alarm list and differentiate between critical
and informational alarms.
Note: Consider documenting how critical and non-critical
criteria were determined.
3.5.6

Informational Messages
Informational Messages shall notify the operator and take no
further action.

3.5.7

Interlocks

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Define the interlocks that are to be supplied with the system. For
example:
The cycle cannot be initiated until the jacket temperature is
above 100C.
The cycle cannot be initiated until the door(s) is closed and
locked.
The cycle cannot be initiated unless adequate steam, air and
water pressure are available.
There are no active alarms.
3.6

Data and Security

Controls provided with Electronic Data Collection intended for use in the
manufacture of pharmaceutical products shall be required to comply with
21 CFR Part 11 . The supplier shall stipulate the methods by which this
criterion is met. It is helpful to be specific here.
Security for data and operator access is provided by (User ID/Password,
Card Reader, Biometric (Fingerprint, eye scan, voice recognition, etc.),
etc.).
3.6.1

User Interfaces
This section should address the following issue:
Operator interface access levels
Access to all Input/Output values and system status bits shall
be provided through a data-communication link.

3.6.2

User Interface with Supervisors and Operators

Insert your interface scheme here. For example:
The CONTROL PLATFORM system shall include interfaces with
the Operator and Supervisor that ensures easy, safe, and reliable
operation.
An operator-interface panel shall be provided and mounted near
the equipment or on the equipment. This panel shall provide the
necessary switches, indicators, and devices to operate the
equipment.

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3.6.2.1

Language requirements
Specify language in which information will be displayed
(i.e. English, Spanish, German, Bilingual, etc.)

3.6.2.2

Displayed Requirements:
State the system of measurement that will be used
(English or Metric (S.I.)).

Parameter
XXXXXXX
YYYYYYY
3.6.3

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Format
(###.#) units
(##) %

Unit(s) of measurement

Security Levels
List the total number of different access levels that will be
required. Provide a general description of the access rights for
each level (screen navigation, operational control, control loop
variable manipulation, alarm setpoint manipulation, etc.).

3.6.4

Interface with Other Equipment

The control system shall include the interfaces necessary to
facilitate operation and configuration. For example:

3.6.5

An RS-232 communications port shall be provided.

A Modem communications port shall be provided.

A high-speed configuration/monitoring connection shall

be provided.

Data Collection
Consider any archiving and reporting requirements here.

None

Recorder

Process Printout

Electronic process printout, Historical Trending

Electronic process printout, Historical Trending and interface

to company network

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Define the list of process variables to be recorded and frequency of

recording. For example:

3.7

Chamber Temperature

Chamber Pressure

Jacket Temperature

Run Time

If the system provides a report, define the expectations for

information to be included in the report
Recipe ID
Critical Recipe Parameters
Batch Number
Operator ID
Date / Time of cycle start
Alarms
Sterilizer ID#
Time, Pressure, and Temperature at:
End of each vacuum
End of each pressure pulse
Start of plateau period
End of plateau period
Start of drying period
End of drying period

Environment
Provide details of the physical environment in which the
[equipment/system] will be operated. Also note the maximum height,
width and depth that the equipment can be to fit through doorways from
the point where the equipment enters the building to the point of
installation.
3.7.1

Layout
For example: Allocated floor space for the equipment is _____
inches by ________ inches with at least a _______inch corridor
around the periphery for the equipment.

Vertical clearance is _________ inches.

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See attached drawing #________________________ (if

applicable).

Floor or pit mounted

Cabinet mounted

Recessed in 1 or 2 walls

Door type: hinged, vertical or horizontal sliding

Bio-seal requirements

Layout is specific to the size equipment being used and system

requirements of the equipment.
Maximum allowable:

Height
Length
Depth
Weight
Floor Load

3.7.2 Physical Conditions

Room Explosion Classification

List the critical explosion requirements for the room.
Room will be non-hazardous
Room will be Class I Div II (Zone 2) (explosive
atmosphere present at known times)
Room will be Class I Div I (Zone 1) (explosive
atmosphere present at all times)

Environmental Classification
List the critical air quality requirements for the environment.
Class 100, 10,000, or 100,000 (Federal Standard 209E)
ISO Class 5, 7, or 8 (ISO 14644-1 and ISO 14644-2)
Class A, B, C, or D (The Rules Governing Medicinal
Products in the European Union Annex 1)
Directional airflow
Airflow velocity

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Number of air changes

Particle Ingress

Biohazard Level
List the critical biohazard level requirements for the
environment.

BL-1
BL-2
BL-3
BL-4

Rating of enclosures
List the rating requirements for enclosures in the environment.

NEMA 1 (Open)
NEMA 12 (Oil tight)
NEMA (Wash down)
NEMA 4X (Washdown and non-Corrosive)

3.7.3 Cleaning Requirements

Hand-Wash
Auto-Wash
Sanitization
Steam Clean

3.7.4 Intended Operating Environment:

Describe the type of operating environment that the
[equipment/system] will be exposed to following installation.
For example: The [equipment/system] shall be mounted in a GMP
environment with a temperature range of 15 to 25 C, noncondensing humidity.
Vibration levels in operating environment are <Negligible, Slight,
or Severe>
The Seismic Zone in the operating environment is <Zone 1, Zone
2, Zone 3, Zone 4, or Zone 4A>.

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4.0 CONSTRAINTS
4.1

Milestones and Timelines

Use one of the two schedule outlines provided below. Delete the schedule
not selected for use. Fill in time scales or dates as appropriate and
add/delete items as applicable. If available, refer to the users project
schedule to assist with this area. An agreed upon timeline may be
referenced here and attached as an appendix.
The parties involved should submit a basic timeline as outlined below:

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Equipment Constraints
Describe the operating constraints that the [equipment/system] will be
required to meet.
For example:
4.2.1

Environmental Conditions
The [equipment/system] is to be used at the following
environmental conditions:
Altitude ________ ft above sea level

4.2.2

Equipment Generated Vibration

The maximum allowable equipment vibration generated during
operation is <value>.

4.3

Compatibility and Support

Include any requirements for compatibility with other User systems. In
the examples provided below, fill in blanks with the appropriate
information. Delete areas that are not applicable to this application.
4.3.1

CONTROL PLATFORM Controllers

The Supplier shall utilize
Control Platform
Controllers that shall include a communications port.
The Supplier shall provide documentation that the program
(embedded software) was developed and coded utilizing
program development and documentation software.
The supplier shall indicate the use of custom or bespoke code
within the equipment, and shall supply licensing of the custom
code for the life of the equipment.
An escrow agreement shall be required in the event the supplier
cannot support the supplied custom software any longer. In such
instances, the source code and all information regarding the source
code shall be given to the user in a timely fashion to prevent
downtime of the equipment.

4.3.2

Preferred Vendor List

If necessary the user may attach a Preferred Manufacturers List of
critical components. Refrain from driving the supplier into

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customizing their equipment for your company. If the supplier

wishes to deviate from the Preferred Manufacturers List, a listing
of the proposed components and instrumentation manufacturers
indicating type and model numbers shall be submitted with the
quotation, along with an explanation of why the deviation is
recommended.
4.3.3

Utilities
The utilities and space involved needs to be discussed prior to
purchasing the equipment. Obviously, the actual equipment size is
but a small part of the entire scope of work necessary to implement
a larger system. The unit and its support equipment must be able to
be installed in current building facilities.
The User shall ensure that the following utilities are available and
that the utility supply lines and piping are terminated with fittings
or connections, which are compatible with those described on the
Customer Connection Drawings.
The Supplier shall specify utility data, which is marked with a
triangle or code of some type (number code). Utility data, which
are not specified or marked with a triangle or code, shall be
brought to the attention of the User. These data shall be specified
(by the User or the Supplier) and shall be approved by both the
User and the Supplier before system design begins.
Base Utilities Worksheet

Related Discharges
Volume
PH
Temperature
Materials
User should indicate the maximum or minimum
volume, pH, temperature, etc. of discharges

Electricity
______ VAC ____ Hertz

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Phases
Amperage
Uninterruptible Power Supply (Define Use)

Control Air
Pressure
For example:
_______ PSIG (must be clean, dry ISA instrument
quality air, capacity to be determined by size of
equipment). Recommend at least 90 PSIG
constant air pressure for all equipment, unless
specified.

Clean/Pure Steam (also must specify if pure or clean

steam is to be used. Further, detail if plant steam to be
used in jacket and then add plant steam requirements if
appropriate.
Pressure in chamber
For example:
_______ PSIG
_______ Volume (peak and average)
Pressure in jacket
For example:
_______ PSIG
_______ Volume (peak and average)

Other Utility Requirements

Provide details regarding any other utility systems that are required to support operation
of the equipment/system (e.g

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Availability
The [equipment/system] is intended to be operated <Continuously,
Regularly, __ hours per day, __ hours per week>.
Operation of the [equipment/system] shall be suspended, and the system
shall be available for preventative maintenance or routine service <__
hours per week, __ continuous hours per week, __ days per month, __
weeks per year>.

4.5

Procedural Constraints
4.5.1

Autoclave Interior Finish

Describe any local procedural requirements such as local
standards, which must be adhered to if applicable.
Describe materials of construction and requirements for material
certification.
List critical requirements for surface finish, roughness, etc.
Other standards are attached. The Supplier shall adhere to the
indicated sections only.

4.5.2 Autoclave Exterior Finish

Describe external sheet metal materials and finishes of the
autoclave. This is especially critical for the side that would
interface to an aseptic area.
4.5.3 Critical Piping Finishes
All piping welds for clean steam, pharmaceutical air, sanitary
chamber drain and sterile vent system shall be manufacture to
standards (e.g. AISI, ASTM or ASME).. Piping shall be (316L
Stainless Steel, 316 Stainless Steel, 304 Stainless Steel, etc.)
List critical requirements for surface finish, roughness, etc.
Typically 25-35 micro-inch RA is acceptable for steam and air.
Other standards are attached. The Supplier shall adhere to the
indicated sections only.

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4.5.4 Noise Level Constraints

Insert your own noise level constraint requirements here.
For example: The noise level generated during operation of the
[equipment/system] will not exceed 85 DB from 3 feet away.
4.5.5

EMI / RFI levels are:

Insert your own electrical and radio noise immunity requirements
here.
For example:
The [equipment/system] [will/will not] be used in an area
where two-way radio communication devices are in
operation. The [equipment/system] shall meet CE
requirements for electrical noise immunity and emissions.

4.5.6 Labeling
All equipment, components, and control wiring shall be labeled
and identified.
4.6

Maintenance
Describe the expected hardware and software maintenance support
including: ease of maintenance, expansion capability (software only),
likely enhancements (software only), expected lifetime and long-term
support.
Include the necessary wiring or other installation requirements to support
periodic calibration and preventative maintenance.
System shall be maintained on a schedule as indicated by the supplier.
Supplier is to provide (at minimum) the following maintenance
instructions:
1.
All sub-systems provided (Maintenance and operation manuals
of vendor equipment)
2.
A comprehensive lubrication list and recommended lubrication
schedule

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A comprehensive recommended maintenance (regular

recommended inspection intervals, wear points, recommended
spare parts list)
Supplier shall supply ______ Copies of Operation, Installation,
Maintenance and de-commissioning manuals

3.

4.

5.0 LIFE-CYCLE
5.1

Development
If S88 is to be applied to the equipment being acquired, it should be
referenced in this section of the document.
The Supplier shall provide a Quality and Project Plan as part of their
proposal. The Supplier shall have a quality system in place. Internal
quality procedures shall be available for the Users review.
The Supplier shall provide a Project Manager for the project to provide a
single communication point with the User.
The project shall utilize the GAMP methodology when developing the
system and documentation.

5.2

Testing
Describe the Supplier testing requirements. Reference the Validation Test
Plan, Factory Acceptance Test, special tests, etc. This section should also
include required amount of demonstrated run time, any special materials
necessary to complete testing, integration testing, etc.
In order to verify system performance, the User shall witness the
execution of the Factory Acceptance Test procedures. The Supplier shall
notify the User _______ weeks in advance of the start of this test.
The Factory Acceptance Test Specification shall be submitted to the User
for review and approval prior to execution. A minimum of _______
weeks shall be allowed for the User to review and to comment and/or
approve the Factory Acceptance Test Specification.
Refer to the Equipment Validation Plan for applicable procedures.

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5.3 Delivery
The [equipment/system], with all options, equipment, and the
documentation listed below, shall be delivered to the Users receiving
dock.
5.3.1

Documentation
Installation, operation, and maintenance instruction documentation
for the system shall be developed to a level that is comprehensible
to a high school graduate.
The Supplier shall use the formats described in the GAMP
Supplier Guide, Current Version, to produce the documentation.
The Supplier shall provide the documentation for preliminary
review. The Supplier shall provide documentation reflecting asbuilt condition with final delivery.
All final documents shall be shipped with transmittals that identify
them as contractually required documents. All final documents
and drawings shall reflect as-built condition.
All documents shall in the language of the destination country and
supplied with hard copies and electronic versions supplied in the
format identified for each document:

User should define format for document transmission (ie. MS Word, Autocad, etc.)
Below is an example:
Project Plan

Microsoft Word 97 (*.doc)

User Requirements Specification

Microsoft Word 97 (*.doc)

Functional Specification/Requirements

Microsoft Word 97 (*.doc)

Design Specifications

Microsoft Word 97 (*.doc)

Controls Test

Microsoft Word 97 (*.doc)

Hardware Installation Test

Microsoft Word 97 (*.doc)

Operational Test

Microsoft Word 97 (*.doc)

Factory Acceptance Test

Microsoft Word 97 (*.doc)

Operator, Maintenance and Service Manuals

Microsoft Word 97 (*.doc)

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Process and Instrumentation Diagram (P&ID)

Instrument Listing

August 19, 2002

AutoCAD version 12.0 (*.dxf)

Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

Control Schematics

AutoCAD version 12.0 (*.dxf)

Control Panel Assembly Drawings

AutoCAD version 12.0 (*.dxf)

Equipment Assembly Drawings

AutoCAD version 12.0 (*.dxf)

Bill of Materials

Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

Spare Parts List

Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

Component Cut Sheets

Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

CONTROL PLATFORM Program

Printout and Disk File

XXX Program Development format

OIP Configuration Printout and Disk File

XXX Program Development format

Certificates of compliance for materials, welding, surface finish inspection.

5.4 Support
Describe what support activities are required after acceptance. The
paragraphs outlined below provide some areas for consideration.
5.4.1

Start-up Support (list available options)

5.4.1.1

5.4.2

Training (list training options available)

Post Start-up Support (list post-startup support available)

5.4.2.1

Technical Support
Telephone (Voice or Modem)
Replacement Parts Availability List (Normal lead times
shall be listed)

5.4.2.2

User Site Support

Preventative Maintenance (list maintenance contracts
available)

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System Improvements (supplier shall notify user of any

improvements available on a regular basis)

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6.0 GLOSSARY
If necessary, attach a glossary, which includes definitions of terms that may be
unfamiliar to the Supplier or terminology that may have meanings specific to
entries on this User Requirements Check sheet.
For example (example list is not intended to be complete):
Acronym

Definition

Degrees Celsius

BL

Biohazard Level

CFR

Code of Federal Regulations

DB

Decibels

EMI

Electro-Magnetic Interference

Ft

Feet

GUI

Graphic User Interface

HMI

Human Machine Interface

HVAC

Heating, Ventilation, and Air Conditioning

ISO

International Organization for Standardization

JETT

Joint Equipment Transition Team

LEL

Lower Explosion Limit

OIP

Operator Interface Panel

RFI

Radio Frequency Interference

URS

User Requirement Specification

Pure Steam

Non-condensed WFI

Clean Steam

Steam produced from deionized water

Plant Steam

Steam used in general plant applications.

Typically contains additives designed to
facilitate condensate collection and reuse.

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7.0 REFERENCES
List references that were used in preparing this document or that provide
additional details, such as:
o Equipment Validation Plan
o Current revision of GAMP Guidelines
o Vendor Piping Certification (if applicable)
o Customer Connection Diagram
o Approved Instrumentation List
o Process Flow Diagram
o 21 CFR Part 11
o National Electric Code
o S88

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8.0 APPROVAL
Insert your companys standard approval page at the appropriate position in the
document or utilize the sample approvals listed below. The approval
process/requirements should be outlined in the Equipment Validation Plan.
This document has been reviewed by the User Project Manager and approved for use by the
Supplier.

Printed/Typed Name

Signature

Date

This document has been reviewed by the User Quality Assurance Group and approved for
use by the Supplier.

Printed/Typed Name

Signature

Date

This document has been reviewed by the Supplier Project Manager and approved for use by
the Supplier Project Team.

Printed/Typed Name

Signature

Date

Other approvals as necessary may be included, such as the Technical Services Groups,
User Groups, Engineering, etc. as required.

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