USER REQUIREMENTS TEMPLATE by 2IY3h22

VIEWS: 34 PAGES: 29

									           USER REQUIREMENTS          Page 1 of 28
             SPECIFICATION        Doc ID: Chromatography
JETT     CHROMATOGRAPHY LIQUID          URS_Rev. 0
                                         May 2002
            HANDLING SYSTEM

        USER REQUIREMENTS TEMPLATE
for a Chromatography Liquid Handling SYSTEM




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                         USER REQUIREMENTS                               Page 2 of 28
                           SPECIFICATION                             Doc ID: Chromatography
   JETT               CHROMATOGRAPHY LIQUID                                URS_Rev. 0
                                                                            May 2002
                         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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                       USER REQUIREMENTS                          Page 3 of 28
                         SPECIFICATION                       Doc ID: Chromatography
       JETT           CHROMATOGRAPHY LIQUID                        URS_Rev. 0
                                                                    May 2002
                         HANDLING SYSTEM



                       REVISION HISTORY

Rev.      Date         Author     REVISION SUMMARY/
 0     May 14, 2002   R. LeDoux   Initial issue to the JETT website.
                       (JETT)




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                                  USER REQUIREMENTS                                                Page 4 of 28
                                    SPECIFICATION                                           Doc ID: Chromatography
      JETT                   CHROMATOGRAPHY LIQUID                                                URS_Rev. 0
                                                                                                   May 2002
                                HANDLING SYSTEM

                                    TABLE OF CONTENTS
1.0     INTRODUCTION.............................................................................................. 5

2.0     OVERVIEW ....................................................................................................... 5

3.0     OPERATIONAL REQUIREMENTS .............................................................. 6
  3.1      PRODUCTION ................................................................................................... 6
  3.2      CLEANING REQUIREMENTS ............................................................................ 6
  3.3      PROCESS CONTROL ......................................................................................... 6
  3.4      FUNCTIONS ...................................................................................................... 9
  3.5      DATA AND SECURITY ..................................................................................... 13
  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 ............................................................................................... 20
  4.5      PROCEDURAL CONSTRAINTS ........................................................................ 21
  4.6      MAINTENANCE .............................................................................................. 22
5.0     LIFE-CYCLE ................................................................................................... 22
  5.1      DEVELOPMENT .............................................................................................. 22
  5.2      TESTING ......................................................................................................... 23
  5.3      DELIVERY ...................................................................................................... 23
  5.4      SUPPORT ........................................................................................................ 24
6.0     GLOSSARY...................................................................................................... 26

7.0     REFERENCES ................................................................................................. 28

8.0     APPROVAL ..................................................................................................... 29




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                         USER REQUIREMENTS                              Page 5 of 28
                           SPECIFICATION                         Doc ID: Chromatography
   JETT               CHROMATOGRAPHY LIQUID                            URS_Rev. 0
                                                                        May 2002
                         HANDLING SYSTEM

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, pilot-
       development, 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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                            USER REQUIREMENTS                            Page 6 of 28
                              SPECIFICATION                         Doc ID: Chromatography
  JETT                   CHROMATOGRAPHY LIQUID                            URS_Rev. 0
                                                                           May 2002
                            HANDLING SYSTEM

3.0   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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                  USER REQUIREMENTS                             Page 7 of 28
                    SPECIFICATION                           Doc ID: Chromatography
JETT           CHROMATOGRAPHY LIQUID                              URS_Rev. 0
                                                                   May 2002
                  HANDLING SYSTEM


       3.3.2   Control System Operation Modes

               Choose from the following list of options:

                     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)

       3.3.3   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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                  USER REQUIREMENTS                            Page 8 of 28
                    SPECIFICATION                         Doc ID: Chromatography
JETT           CHROMATOGRAPHY LIQUID                            URS_Rev. 0
                                                                 May 2002
                  HANDLING SYSTEM

       3.3.6   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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                   USER REQUIREMENTS                         Page 9 of 28
                     SPECIFICATION                       Doc ID: Chromatography
JETT           CHROMATOGRAPHY LIQUID                           URS_Rev. 0
                                                                May 2002
                  HANDLING SYSTEM


 3.4   Functions

       3.4.1   Operation

               3.4.1.1   Flow Rate Requirements

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

               3.4.1.2   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 (pre-
                              pump) 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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            USER REQUIREMENTS                          Page 10 of 28
              SPECIFICATION                        Doc ID: Chromatography
JETT     CHROMATOGRAPHY LIQUID                           URS_Rev. 0
                                                          May 2002
            HANDLING SYSTEM

         3.4.1.5   Fraction Collection

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

         3.4.1.6   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

                       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)

         3.4.1.8   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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                   USER REQUIREMENTS                            Page 11 of 28
                     SPECIFICATION                          Doc ID: Chromatography
JETT            CHROMATOGRAPHY LIQUID                             URS_Rev. 0
                                                                   May 2002
                   HANDLING SYSTEM

       3.4.2    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.
                              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).

       3.4.3   “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                             Page 12 of 28
                             SPECIFICATION                           Doc ID: Chromatography
   JETT                 CHROMATOGRAPHY LIQUID                              URS_Rev. 0
                                                                            May 2002
                           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:
                                                                            Informational
         Alarm or Informational Message                       Critical
                                                                               Message
Emergency Stop                                                   X
Control Platform Communication Watchdog                          X
Control Power Fault                                              X
Main Air Fault                                                   X
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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                      SPECIFICATION                        Doc ID: Chromatography
JETT             CHROMATOGRAPHY LIQUID                           URS_Rev. 0
                                                                  May 2002
                    HANDLING SYSTEM

 3.5   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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                      SPECIFICATION                         Doc ID: Chromatography
JETT               CHROMATOGRAPHY LIQUID                          URS_Rev. 0
                                                                   May 2002
                      HANDLING SYSTEM


                   Parameter                 Format           Unit(s) of measurement
                XXXXXXX                    (###.#) units
                YYYYYYY                       (##) %

       3.5.3   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:
                         An RS-232 communications port shall be provided.
                         A Modem communications port shall be provided.
                         A high-speed configuration/monitoring connection
                          shall be provided.

       3.5.5   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:
                    XXXXX
                    YYYYY
                    ZZZZZ

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

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                       SPECIFICATION                          Doc ID: Chromatography
JETT               CHROMATOGRAPHY LIQUID                            URS_Rev. 0
                                                                     May 2002
                      HANDLING SYSTEM

       3.6.1   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.
                   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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                    SPECIFICATION                        Doc ID: Chromatography
JETT           CHROMATOGRAPHY LIQUID                           URS_Rev. 0
                                                                May 2002
                  HANDLING SYSTEM

       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 <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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                        USER REQUIREMENTS                          Page 17 of 28
                          SPECIFICATION                        Doc ID: Chromatography
  JETT               CHROMATOGRAPHY LIQUID                           URS_Rev. 0
                                                                      May 2002
                        HANDLING SYSTEM


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 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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                     SPECIFICATION                        Doc ID: Chromatography
JETT            CHROMATOGRAPHY LIQUID                           URS_Rev. 0
                                                                 May 2002
                   HANDLING SYSTEM


 4.2   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:
                  Winter dry bulb         C
                  Winter wet bulb         C
                  Summer dry bulb         C
                  Summer wet bulb         C
       4.2.3   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.




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                    USER REQUIREMENTS                            Page 19 of 28
                      SPECIFICATION                          Doc ID: Chromatography
JETT             CHROMATOGRAPHY LIQUID                             URS_Rev. 0
                                                                    May 2002
                    HANDLING SYSTEM

       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 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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                     SPECIFICATION                          Doc ID: Chromatography
JETT            CHROMATOGRAPHY LIQUID                             URS_Rev. 0
                                                                   May 2002
                   HANDLING SYSTEM

                      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 <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 <__



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                      SPECIFICATION                          Doc ID: Chromatography
JETT             CHROMATOGRAPHY LIQUID                             URS_Rev. 0
                                                                    May 2002
                    HANDLING SYSTEM

       hours per week, __ continuous hours per week, __ days per month, __
       weeks per year>.

 4.5   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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            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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       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.



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                            HANDLING SYSTEM

                     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)
    Process and Instrumentation Diagram (P&ID)          AutoCAD version 12.0 (*.dxf)
    Instrument Listing                   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

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




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                    HANDLING SYSTEM

       5.4.1   Start-up Support (list available options)

               5.4.1.1   Training (list training options available)

       5.4.2   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     GLOSSARY
    Acronym                                       Definition
        C          Degrees Celsius
      ASME          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       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.
       EMI          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          feet
      GAMP          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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 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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  Acronym                                      Definition
 Sample Pump      A pump used exclusively for the addition of sample onto the
                  column. Typically bypasses all valves prior to the column to
                  minimize dilution.
      SS          Stainless Steel
      UPS         Uninterruptible Power Supply
      URS         User Requirement Specification
      UV          Ultraviolet Light
 UV Detector      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.




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 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.




                     JOINT EQUIPMENT TRANSITION TEAM

								
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