Jett Chromatography Urs Template

JETT

USER REQUIREMENTS SPECIFICATION

CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Page 1 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

USER REQUIREMENTS TEMPLATE for a Chromatography Liquid Handling SYSTEM

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Page 2 of 28

USER REQUIREMENTS SPECIFICATION

Doc ID: Chromatography URS_Rev. 0 May 2002

CHROMATOGRAPHY LIQUID HANDLING SYSTEM

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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CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Page 3 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

REVISION HISTORY Rev.

Date

Author

0

May 14, 2002

R. LeDoux (JETT)

REVISION SUMMARY/ Initial issue to the JETT website.

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USER REQUIREMENTS SPECIFICATION

CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Page 4 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

TABLE OF CONTENTS 1.0

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

2.0

OVERVIEW ....................................................................................................... 5

3.0

OPERATIONAL REQUIREMENTS .............................................................. 6

3.1 3.2 3.3 3.4 3.5 3.6 4.0 4.1 4.2 4.3 4.4 4.5 4.6 5.0 5.1 5.2 5.3 5.4

PRODUCTION ................................................................................................... 6 CLEANING REQUIREMENTS ............................................................................ 6 PROCESS CONTROL ......................................................................................... 6 FUNCTIONS ...................................................................................................... 9 DATA AND SECURITY ..................................................................................... 13 ENVIRONMENT............................................................................................... 14 CONSTRAINTS............................................................................................... 17 MILESTONES AND TIMELINES ....................................................................... 17 EQUIPMENT CONSTRAINTS ........................................................................... 18 COMPATIBILITY AND SUPPORT ..................................................................... 18 AVAILABILITY ............................................................................................... 20 PROCEDURAL CONSTRAINTS ........................................................................ 21 MAINTENANCE .............................................................................................. 22 LIFE-CYCLE ................................................................................................... 22 DEVELOPMENT .............................................................................................. 22 TESTING ......................................................................................................... 23 DELIVERY ...................................................................................................... 23 SUPPORT ........................................................................................................ 24

6.0

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

7.0

REFERENCES ................................................................................................. 28

8.0

APPROVAL ..................................................................................................... 29

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USER REQUIREMENTS SPECIFICATION

CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Page 5 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

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, User Requirements Specification.

1.0

INTRODUCTION

2.0

OVERVIEW The Chromatography Liquid Handling System is designed for the purification of low, medium, or highly active compounds (editor to select one level) and enables the User to, using a separate chromatography column, separate and purify proteins and other compounds. It is designed for used in research, pilotdevelopment, small-scale, or large-scale production (editor to select one level). The system is sanitary in design with a unique piping configuration that provides optimal fluid management with minimal unswept volumes (dead legs). The low-pressure gradient formation feature of the system allows for formation of fixed isocratic mobile phases, or linear gradients where mobile phase composition varies over time. Fraction collection and UV monitoring are further requirements of the system. The equipment will be used in an aqueous, low LEL solvent, or high LEL solvent environment (editor to select one environment), which may require specific electrical requirements. Typical solvents used may include, but are not limited to, ethanol, isopropanol, and methanol. Note: You may wish to include your own requirements and specifics to allow the inexperienced reader, contractor, and/or supplier adequate explanation to understand the scope of the equipment. For example, a statement of general product rate requirements. The product itself may pose environmental and exposure hazards that need to be dealt with to implement the installation of the equipment. The utilities and space involved needs to be discussed prior to purchasing the equipment. The actual equipment size is but a small part of the entire scope of the work necessary to implement a larger system. The unit and it’s support equipment must be able to be installed in current or proposed building facilities.

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CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Page 6 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

OPERATIONAL REQUIREMENTS 3.1

Production 

The chromatography System shall be capable of operating the following columns: List column sizes to be used and their respective linear velocity requirements.

3.2

Cleaning Requirements 

The system is designed to be Clean in Place (CIP). This process is conducted by adding a cleaning manifold to the inlet lines and pumping a cleaning solution through the system. 1. Special Requirements: (ex. Inlet CIP manifolds, Steam-in Place

sanitization, etc.) _________________ Note: At a minimum, list the critical, process parameters. Consider documenting how each of the parameter requirements was determined. 3.3

Process Control 3.3.1

Control System Hardware  OIP and system software shall reside on a Control System residing on either the system or separated from it. Software shall control all access to the system, including manual and automatic operation, maintenance, recipe writing, and other functions that are used to operate the system.  The software system shall automatically download the recipes and individual commands to the control system. The control system shall operate as the direct interface to the hardware, controlling all functions of the system and data acquisition. Note to the editor: a second option, including no control system, may be chosen. In this case, requirements for “landed lines” only shall be required.

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CHROMATOGRAPHY LIQUID HANDLING SYSTEM 3.3.2

Page 7 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

Control System Operation Modes Choose from the following list of options:        

3.3.3

Manual operation Automatic operation – hardcode sequence Automatic Operation – User programmable recipes (methods) are downloaded and automatically executed by the equipment Data archiving and display of archived data Batch reporting Recipe capabilities Recipe storage (edit/insert additional requirement here)

Operator Interface Terminal (OIT) Choose from the following list of options:     

List OIT options Limited functionality OIT on the machine (assumes an additional, fully functional, remote OIT) Fully Functional OIT on the machine Fully Functional Remote OIT View Only Remote OIT

3.3.4

Manual Buttons and Switches/Touch screen Control  Main Power on/off  Pump on/off  Waste/Fraction select  Fraction advance  (list additional requirements here)

3.3.5

Language requirements  English  Other (Specify): ___________________

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CHROMATOGRAPHY LIQUID HANDLING SYSTEM 3.3.6

Page 8 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

Interface With Other SystemsDelete any of the listed functions/indications that are not applicable for this application and add additional functions/indications as required. Edit as appropriate; this section details connections to tank levels, external data archive, remote terminals, etc. The control system shall include interfaces with the User’s control system to facilitate automatic operation and configuration.   

A system with an RS-232 communications port shall be provided. A system with a Modem communications port shall be provided. A high-speed configuration/monitoring connection shall be provided.

The port shall be capable of being configured to communicate the following data to a supervisory control and data acquisition (SCADA) node (Note: the SCADA system shall be supplied and installed by the User): Choose from the following list:  All process variables  Alarms and Warnings.  System Status (e.g. “off,” “ on,” “standby” states, etc.).  Other __________________________ (specify). 3.3.7

Interface with Other Equipment The PLC/OIT system shall include interfaces with external equipment to ensure safe, continuous, and (if applicable) automatic operation.

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3.4

CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Page 9 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

Functions 3.4.1

Operation 3.4.1.1

Flow Rate Requirements  

3.4.1.2

Maximum: _____Lpm (insert your requirement here) Minimum: _____Lpm (insert your requirement here)

Pressure Requirement 

Maximum pressure shall be ____psig (insert your requirement here)

3.4.1.3

Gradient Formation  Step binary gradient (manual or automatic from recipe/method).  Linear binary gradient (manual or automatic from recipe/method).  Gradient Formation with Conductivity Feedback (manual or automatic from recipe/method).  Gradient formation is to be low pressure (prepump) capable of binary gradients and with two (2) additional inlets (on/off or 0%/100%)  (edit/insert your requirement here)

3.4.1.4

Gradient Accuracy 

Gradient concentration shall be accurate to within __% (insert your requirement here) between ___% and ___% of full gradient range. (insert your requirement here)

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CHROMATOGRAPHY LIQUID HANDLING SYSTEM 3.4.1.5

Doc ID: Chromatography URS_Rev. 0 May 2002

Fraction Collection  

3.4.1.6

Page 10 of 28

System shall be capable of collecting a maximum of (___) Fractions. (insert your requirement here)

UV Monitoring     

System shall be capable of monitoring; Fixed, single wavelength of __nm or Dual Wavelength detector at __ nm and ___ nm. (insert your requirement here) Adjustable wavelengths from ___ nm to ____nm. (insert your requirement here) UV auto zero Functionality (insert your requirement here). UV Flow Cell shall be full flow design (substitute split cell design)(edit your requirement here)

3.4.1.7 Sample Pump 

3.4.1.8

System shall include a separate pump optimized for delivery of product mixture into the system/column. (edit/insert your requirement here; this may or may not be required, depending on the application)

Materials of Construction  All wetted parts shall be made of the following materials:  Piping: 316L SS; surface finish 20 Ra with electropolish and passivation  Pump: 316 SS; surface finish 20 Ra with electropolish and passivation  Valving: 316L SS; surface finish 20 Ra with electropolish  Gaskets: EPDM  Frame and electrical enclosure shall be manufactured from 304SS. All welds shall be ground smooth  Electrical Enclosures shall be NEMA 4X. (Insert your requirements here).

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CHROMATOGRAPHY LIQUID HANDLING SYSTEM 3.4.2

Page 11 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

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

Personnel



Equipment



Product

Recovery Methods: Insert your specific recovery scheme here.

3.4.3



Manually re-start based on operator inputs (Operator initiates power recovery sequence).



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).

“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 easily accessible areas around the equipment as required by local safety standards.

3.4.4

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

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USER REQUIREMENTS SPECIFICATION

JETT

Doc ID: Chromatography URS_Rev. 0 May 2002

CHROMATOGRAPHY LIQUID HANDLING SYSTEM

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: The Equipment shall have the following critical alarms and warnings: Alarm or Informational Message

Critical

Emergency Stop Control Platform Communication Watchdog Control Power Fault

X X X

Main Air Fault

X

Informational Message

XXXX YYYY ZZZZ Motor Faults CONTROL PLATFORM Battery Low Warning

X

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 non-critical alarms. Note: Consider documenting how “critical and informational” criterions were determined. 3.4.5

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

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JETT 3.5

CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Page 13 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

Data and Security Controls provided with Data Collection systems intended for use in the manufacture of pharmaceutical products shall be required to meet 21 CFR Part 11 compliance. The supplier shall stipulate the methods by which this criterion is met. 3.5.1

User Interfaces This section should address the following issues:  Operator interface access levels  Frequency of data point collection  Hardcopy/electronic data collection requirements  Compliance with 21CFR Part 11 (for Europe - EREC Guidelines)  Data retention time on the system  Data storage media Access to all Input/Output values and system status bits shall be provided through a data-communication link. Security for data and operator access is provided by (User ID/Password, Card Reader, Biometric (Fingerprint, eye scan, voice recognition, etc.), etc.).

3.5.2

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. 3.5.2.1

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

3.5.2.2

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

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CHROMATOGRAPHY LIQUID HANDLING SYSTEM Parameter XXXXXXX YYYYYYY 3.5.3

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

Page 14 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

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.).

3.5.4

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

3.5.5



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

The following shall be recorded:    3.6

XXXXX YYYYY ZZZZZ

Environment Provide details of the physical environment in which the [equipment/system] will be operated.

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CHROMATOGRAPHY LIQUID HANDLING SYSTEM 3.6.1

Page 15 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

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.



See attached drawing #________________________ (if applicable).

Layout is specific to the size equipment being used and system requirements of the equipment. 3.6.2 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  Number of air changes  Particle Ingress



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

NEMA 1 (Open) NEMA 12 (Oiltight) NEMA (Washdown) NEMA 4X (Washdown and non-Corrosive)

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Page 16 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

3.6.3 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, non-condensing humidity. Vibration levels in operating environment are The Seismic Zone in the operating environment is .

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4.0

USER REQUIREMENTS SPECIFICATION

CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Page 17 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

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 User’s 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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CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Page 18 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

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

HVAC Equipment Constraints Process air enters in from… Indoor Temperature:

C

Outdoor Temperature: Minimum:

C

Maximum:

C

Climatic conditions:

4.2.3

Winter dry bulb

C

Winter wet bulb

C

Summer dry bulb

C

Summer wet bulb

C

Equipment Generated Vibration The maximum allowable equipment vibration generated during operation is .

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.

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CHROMATOGRAPHY LIQUID HANDLING SYSTEM 4.3.1

Page 19 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

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 attach any critical preferred vendors. Refrain from driving the supplier into customizing his equipment package. If the Supplier wishes to deviate from the Preferred Instrumentation List, a listing of the proposed components and instrumentation sub-vendors 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. Utility data, which are not specified or marked with a triangle, 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.

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Page 20 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

Base Utilities Worksheet

Related Discharges  Volume  pH  Temperature  Materials

Electricity  ______ VAC ____ Hertz  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.

Other Utility Requirements Provide details regarding any other utility systems that are required to support operation of the equipment/system. 4.4

Availability The [equipment/system] is intended to be operated . Operation of the [equipment/system] shall be suspended, and the system shall be available for preventative maintenance or routine service .

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CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Page 21 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

Procedural Constraints 4.5.1

Product Contact Materials Describe any local procedural requirements such as local standards, which must be adhered to if applicable. All piping welds and product contact welds shall meet ASME and 3A specification requirements. Product contact metal to be (316L Stainless Steel, 316 Stainless Steel, 304 Stainless Steel, etc.) List critical requirements for surface finish, roughness, etc.. Other standards are attached. The Supplier shall adhere to the indicated sections only.

4.5.2 Product in Contact with Materials All product contact parts should be considered. The [equipment/system] will be used for (aqueous solutions, low LEL (lower explosion limit) solvents, high LEL solvents, etc.). 4.5.3 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. 4.5.4

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.

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Page 22 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

4.5.5 Containment 4.5.5.1

Explosion Protection This section is only valid if the product being used is highly reactive. Insert containment guidelines here (i.e. Bar Construction with isolation and suppression, 10 Bar construction with isolation only, Closed-Loop Nitrogen System, etc.).

4.5.6 Labeling All equipment 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. 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 3. A comprehensive recommended maintenance (regular recommended inspection intervals, wear points, recommended spare parts list) 4. Supplier shall supply ______ Copies of Operation, Installation, Maintenance and de-commissioning manuals

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 User’s review.

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Page 23 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

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.

5.3 Delivery The [equipment/system], with all options, equipment, and the documentation listed below, shall be delivered to the User’s 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 “as-built” 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:

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Page 24 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

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)



Process and Instrumentation Diagram (P&ID)



Instrument Listing



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



AutoCAD version 12.0 (*.dxf)

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

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

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CHROMATOGRAPHY LIQUID HANDLING SYSTEM 5.4.1

Doc ID: Chromatography URS_Rev. 0 May 2002

Start-up Support (list available options) 5.4.1.1

5.4.2

Page 25 of 28

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) System Improvements (supplier shall notify User of any improvements available on a regular basis)

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6.0

USER REQUIREMENTS SPECIFICATION

CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Page 26 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

GLOSSARY

Acronym

C ASME

Definition

Degrees Celsius American Society of Mechanical Engineers

BL

Biohazard Level

CE

The CE mark is the official marking required by the European Community for all Electric- and Electronic equipment that will be sold, or put into service for the first time, anywhere in the European community. It proves to the buyer -or user- that this product fulfills all essential safety and environmental requirements as they are defined in the so-called European Directives.

CFR

Code of Federal Regulations

CFR

Code of Federal Regulations

CFR 21, Part 11

Part of the FDA Code of Federal Regulation. Part 11 deals with Electronic Records and Electronic Signatures. Specific requirements are laid out for the production, storage, and editing of electronic records.

CIP

Clean In Place – to clean without disassembly

DB

Decibels

dB

Decibels

Deadleg

EMI

A “tee” or section of piping that does not have constant flow through it. Deadlegs can be sources of contamination and mixing in a system. Electro-Magnetic Interference

EPDM

Elastomer commonly used in gasket materials

E-Stop

Emergency Stop

Fraction Collector A series of valves used to collect discrete aliquots of solvent. Typically located after the UV source. ft GAMP

feet Good Automated Manufacturing Practices. A system for producing quality equipment using the concept of prospective validation following a life-cycle model. Specifically designed to aid suppliers and user in the pharmaceutical industry.

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Page 27 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

Acronym

Definition

GMP/cGMP

Good Manufacturing Practices. Regulations of the FDA and comparable non-US agencies that describe the minimum standards for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packaging, or holding of a drug to assure that such drugs meet the requirements of the Act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.

Gradient

The mixing of two or more solutions to create a dynamic change in solutions feeding the system. Used for controlling the elution of target compounds from a column.

GUI

Graphic User Interface

HMI

Human – Machine Interface

HVAC

Heating, Ventilation, and Air Conditioning

ISA

Instrumentation, Systems, and Automation Society

ISO

International Organization for Standardization

ISO

International Organization for Standardization

Isocratic

A solution that does not change in composition during the separation process

JETT

Joint Equipment Transition Team

LEL

Lower Explosion Limit

Lpm

Liters per minute

mm

millimeter

NEMA

National Electric Manufacturers Association

nm

nanometer

OIP

Operator Interface Panel

OIP

Operator Interface Terminal

PLC

Programmable Logic Controller

Ra

Roughness Average

RFI

Radio Frequency Interference

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USER REQUIREMENTS SPECIFICATION

CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Acronym

Sample Pump

SS

7.0

Doc ID: Chromatography URS_Rev. 0 May 2002

Definition

A pump used exclusively for the addition of sample onto the column. Typically bypasses all valves prior to the column to minimize dilution. Stainless Steel

UPS

Uninterruptible Power Supply

URS

User Requirement Specification

UV

Ultraviolet Light

UV Detector

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A detection device that uses UV energy to excite molecules. The UV energy is detected by a photodiode. The solution flows between the photodiode and the energy source. Typically located directly after the column.

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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USER REQUIREMENTS SPECIFICATION

CHROMATOGRAPHY LIQUID HANDLING SYSTEM

Page 29 of 28 Doc ID: Chromatography URS_Rev. 0 May 2002

APPROVAL Insert your company’s 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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