USER REQUIREMENTS TEMPLATE

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					                                               Page 1 of 26

       USER REQUIREMENTS SPECIFICATION   Doc ID: Glassware Washer
JETT           Glassware Washer                   URS_0

                                              April 17, 2003


       USER REQUIREMENTS TEMPLATE
            GLASSWARE WASHER




       JOINT EQUIPMENT TRANSITION TEAM
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                                USER REQUIREMENTS SPECIFICATION                                               Doc ID: Glassware Washer
      JETT                                          Glassware Washer                                                   URS_0

                                                                                                                     April 17, 2003


                                             TABLE OF CONTENTS
1   INTRODUCTION ..............................................................................................................6
2   OVERVIEW .....................................................................................................................7
3   OPERATIONAL REQUIREMENTS ....................................................................................8
    3.1 FUNCTIONS ..............................................................................................................8
        3.1.1 Items to be cleaned.......................................................................................8
        3.1.2 Soil Load ......................................................................................................8
        3.1.3 Cleaning Compounds ...................................................................................8
        3.1.4 Cleaning Cycle .............................................................................................8
        3.1.5 Throughput...................................................................................................9
        3.1.6 Definition of Satisfactorily Clean ................................................................9
        3.1.7 Definition of Satisfactorily Dry ....................................................................9
        3.1.8 Modes of Operation .....................................................................................9
        3.1.9 Performance .................................................................................................9
        3.1.10 Cycle Time ...................................................................................................9
        3.1.11 Power Failure / Recovery ............................................................................9
        3.1.12 Emergency Stops ........................................................................................10
        3.1.13 Safety – Operator .......................................................................................10
        3.1.14 Alarms and Warnings ................................................................................11
    3.2 DATA .....................................................................................................................11
        3.2.1 Data – Batch Reports .................................................................................11
        3.2.2 Data Collection - SCADA ..........................................................................11
        3.2.3 ER / ES Requirements (FDA CFR 21 Part 11) ..........................................11
        3.2.4 Display requirements .................................................................................11
    3.3 INTERFACES...........................................................................................................12
        3.3.1 User Interface ............................................................................................12
        3.3.2 Interface with Supervisory Systems ...........................................................13
        3.3.3 Interface with Peer Equipment ..................................................................13
        3.3.4 Interface with Equipment ...........................................................................13
    3.4 ENVIRONMENT ......................................................................................................14
        3.4.1 Layout ........................................................................................................14
        3.4.2 Physical Conditions ...................................................................................14
        3.4.3 Intended Operating Environment: .............................................................15
4   CONSTRAINTS ..............................................................................................................16
    4.1 MILESTONE SCHEDULE REQUIREMENTS ................................................................16
    4.2 EQUIPMENT CONSTRAINTS ....................................................................................17
        4.2.1 Environmental Conditions .........................................................................17
        4.2.2 HVAC Equipment Constraints ...................................................................17
        4.2.3 Equipment Generated Vibration ................................................................17
    4.3 COMPATIBILITY WITH PLANT CONTROL SYSTEM ..................................................17

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                                USER REQUIREMENTS SPECIFICATION                                              Doc ID: Glassware Washer
      JETT                                          Glassware Washer                                                  URS_0

                                                                                                                    April 17, 2003

    4.4 COMPATIBILITY WITH STANDARD COMPONENTS ..................................................18
    4.5 CONSTRUCTION COMPATIBILITY ...........................................................................18
    4.6 BUILDING COMPATIBILITY ....................................................................................19
    4.7 COMPATIBILITY WITH PLANT UTILITIES ................................................................19
    4.8 AVAILABILITY .......................................................................................................19
    4.9 PROCEDURAL CONSTRAINTS .................................................................................19
    4.10 MAINTENANCE REQUIREMENTS ............................................................................20
5   LIFE CYCLE ..................................................................................................................21
    5.1 DEVELOPMENT PROCEDURES ................................................................................21
    5.2 TESTING REQUIREMENTS ......................................................................................21
    5.3 DELIVERY REQUIREMENTS ....................................................................................21
        5.3.1 Delivery of System......................................................................................21
        5.3.2 Delivery of Documents ...............................................................................22
    5.4 SUPPORT................................................................................................................23
        5.4.1 Start-up Support (list available options) ...................................................23
        5.4.2 Post Start-up Support (list post-startup support available).......................23
6   GLOSSARY ...................................................................................................................24
7   REFERENCE DOCUMENTS .............................................................................................25

8   APPROVALS ..................................................................................................................26




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                        USER REQUIREMENTS SPECIFICATION                            Doc ID: Glassware Washer
     JETT                              Glassware Washer                                     URS_0

                                                                                        April 17, 2003

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. This document contains italic text that is intended to provide guidance and examples on what
      should be included in each section.

   2. Many areas of this template have selections or tables that have been prepared for guidance and
      ease of template completion. Any options and/or examples that are not applicable to the specific
      document being created should be deleted as well.

   3. To update the final Table of Contents, place the cursor inside the shaded area, press the Right
      mouse key, and select Update Field.

   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 SPECIFICATION               Doc ID: Glassware Washer
      JETT                         Glassware Washer                           URS_0

                                                                          April 17, 2003


                                REVISION HISTORY
Rev        Date        Author                     Revision Summary
 0     17 – Apr - 03    BEF     Initial Release




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                      USER REQUIREMENTS SPECIFICATION                      Doc ID: Glassware Washer
     JETT                           Glassware Washer                                URS_0

                                                                                 April 17, 2003

Project # Insert the unique project number associated with this particular URS

Document # Insert the Document ID and Revision

Document Description Insert Document Description, i.e. Laboratory Glassware Washer User
Requirements Specification

1 INTRODUCTION

    Describe who produced the document, under what authority, and for what purpose

    Example
    This document has been produced by the Project Engineering Department of XYZ
    Engineering under authority of ABC Pharmaceuticals. The purpose of this document is to
    define the customer’s requirements for the purchase and construction of a glassware washer
    and its associated automated control system.

    Describe the contractual status of the document. Include, or reference as an attachment,
    the “legal” paragraph that communicates the customer’s purchasing terms and conditions
    in this section.

    Example
    This document is a legal and binding document between ABC Pharmaceuticals and the
    Supplier.

    Describe the relationship of this document to other documents. This is important for
    equipment that is part of an integrated process or line and will help the Supplier to
    understand and ask questions that may otherwise be overlooked. Include validation plans,
    other equipment specifications (such as engineering company specifications), data sheets,
    etc.

    State the relationship to other specifications that may be provided. Should the URS
    supercede statements made in other specifications that could have been provided by
    engineering firms and may be out of date.

    Note that the Equipment Validation Plan outlining the Supplier’s responsibilities is
    attached.




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                    USER REQUIREMENTS SPECIFICATION                    Doc ID: Glassware Washer
  JETT                           Glassware Washer                               URS_0

                                                                            April 17, 2003



2 OVERVIEW
  State why the washer is being purchased - expansion, modernization, new construction,
  increased reliability, washing of specific machine parts (ie. Slats).

  Example
  The glassware washer shall clean and dry the glassware and /or other items listed below.
  The washer is being purchased to increase the amount of glassware that can be clean in a
  workweek. Expansion of our XYZ product facility has increase the amount of used
  glassware produced requiring an acceleration of the cleaning process.

  State the key objective and benefits of the new washer

  Example
  The washer shall allow unattended washing and drying of the items. This will allow the
  cleaning personnel time to prepare the next batch to be washed, increasing throughput. The
  process of washing shall also become more consistent and reliable, as it will not be based
  on human activities alone.

  State the main functions and interfaces of the new washer

  Example
  The washer shall be capable of being operated by standard washroom personnel. The
  washer shall be tied into the Building Automation System (BAS) as well as the plant’s
  SCADA system.




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                   USER REQUIREMENTS SPECIFICATION                       Doc ID: Glassware Washer
    JETT                         Glassware Washer                                 URS_0

                                                                              April 17, 2003



3   OPERATIONAL REQUIREMENTS
    Describe in detail the operational requirements of the system including system functions,
    interfaces and data. Define the environment in which the system must operate. Critical
    features must be identified.

    3.1    Functions

           3.1.1   Items to be cleaned
                   The washer shall be designed to clean the items listed in Table A. Items
                   may be placed on any number of racks. If possible, items shall be grouped
                   per load as shown.
                   Samples of items to be cleaned will be provided for use by the vendor to
                   design the washer and associated equipment. If samples are not available,
                   drawings of the items will be provided.

           3.1.2   Soil Load
                   The items to be cleaned will be soiled with the materials listed in Table A.
                   The amount of soil ranges from ______________. Soiled samples of all
                   items to be cleaned will be provided for the FAT. As an alternative to the
                   product, the items to be cleaned at the FAT may be soiled with
                   _________________.

           3.1.3   Cleaning Compounds
                   Based on the soil loads listed, the following cleaning agents have been
                   initially selected for use.

                   3.1.3.1   XXX Cleaning Solution

                   3.1.3.2   YYY Acid Solution

           3.1.4   Cleaning Cycle
                   The following cycle shall be used as a starting point for the cleaning
                   process.
                   3.1.4.1   Prewash
                   3.1.4.2   Detergent Wash
                   3.1.4.3   Rinse
                   3.1.4.4   Rinse


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                   USER REQUIREMENTS SPECIFICATION                          Doc ID: Glassware Washer
JETT                                 Glassware Washer                                URS_0

                                                                                  April 17, 2003

                   3.1.4.5   Purified Rinse
                   3.1.4.6   Dry
                   3.1.4.7   Cool Down

        3.1.5      Throughput
                   The existing system for washing these items has a throughput of XXX
                   items per day. The washer shall be designed to satisfactorily clean and dry
                   the amounts of items listed in table A.

                                                 Table A
  Item To Be Washed          Qty /     Dwg         Soil Load                 Comments
                             Day      Attached
 4 Liter Carboys              10        Yes       Dry Powder   It is preferable to wash 4 at a time.


        3.1.6      Definition of Satisfactorily Clean
                   Satisfactorily clean is defined by the following criteria – State the criteria
                   for an item to be clean (i.e. swab testing with X results, no visible product,
                   TOC levels, rinse conductivity levels)

        3.1.7      Definition of Satisfactorily Dry
                   Satisfactorily dry is defined by the following criteria – State the criteria
                   for an item to be dry (i.e. dry to the touch, no large water droplets, 100%)

        3.1.8      Modes of Operation
                   The washer shall only allow automatic operation. The operation shall be
                   started only after the user has loaded the items to be washed, selected the
                   predetermined wash cycle for the load and pressed the Start button.

        3.1.9      Performance
                   The washer shall have an efficiency rate of XXX%, as measured by the
                   actual number of items cleaned during a test day, divided by the number of
                   items specified to be washed per day. Washer efficiency rate excludes
                   downtime due to faulty commodities or supply issues but includes
                   downtime due to maintenance of the washer.

        3.1.10 Cycle Time
               The maximum time desired to run one complete wash / dry cycle is XXXX.

        3.1.11 Power Failure / Recovery
               List any specific requirements for power failure recovery

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           USER REQUIREMENTS SPECIFICATION                     Doc ID: Glassware Washer
JETT                     Glassware Washer                               URS_0

                                                                     April 17, 2003

          Insert your specific power failure/recovery scheme here.

          For example:

          Upon failure of the 3-phase power supply, the washer shall fail to a safe
          state. Operation shall not restart upon power restoration. Operator
          intervention is required to restart a cycle.

          The control system shall maintain its program after a power loss and it
          shall be able to recover with minimal interaction with the operator.

          “Safe State” is defined by the following attributes:
              Supply valves will fail closed
              All motion shall cease
              Motion shall not be resumed without operator interaction
              Cleaning cycle status shall be reset

   3.1.12 Emergency Stops
          List any unique requirements relating to safely shutting down the system,
          including interactions with other systems

          For example:

          Emergency-stop buttons shall be supplied within the reach of the operator
          at normal operator stations. When activated, the emergency stop shall
          shut the system down immediately in accordance with the following
          requirements:

                 Supply valves will fail closed
                 All motion shall cease
                 Motion shall not be resumed without operator interaction
                 Cleaning cycle status shall be reset

   3.1.13 Safety – Operator
          Consider performing or having the supplier perform a risk analysis.

          For example:

          The washer shall be designed to be as safe as possible. Interlocks shall be
          provided on the doors to prevent operation with a door opened.

          The control panels shall be lockable to prevent unauthorized access.

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              USER REQUIREMENTS SPECIFICATION                       Doc ID: Glassware Washer
JETT                         Glassware Washer                                URS_0

                                                                         April 17, 2003



              Additional safety features shall be considered for other operator hazards.


      3.1.14 Alarms and Warnings
             A list of alarms that are a must be included here.

              For example:

              The washer shall monitor its components and have alarms based on
              component or supply failure. These alarms shall alert the user to possible
              damage that may occur in the future if proper maintenance is not
              performed. Alarms shall also be added to protect the process. If the
              process deviates from the validated cycle, the user must be alerted.


3.2   Data
      This section should consider the data collection, data storage, and critical
      parameters. Reference to SCADA systems. Data requirements for printed
      reports.

      3.2.1   Data – Batch Reports
              List critical parameters and useful information to be included on the
              report.

              Batch reports shall include the following data. All items to be input by the
              operator are marked with an asterisk.

      3.2.2   Data Collection - SCADA
              List critical parameters to be transmitted to the SCADA system.

              The following information will be collected via the building SCADA
              system.

      3.2.3   ER / ES Requirements (FDA CFR 21 Part 11)

              List any specific requirements for the storage / collection of data
              applicable to CFR 21 Part 11.

      3.2.4   Display requirements

              List any special requirements for data to be displayed on the OIT.
              Examples include P&ID, reports, date / time formats.

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                 USER REQUIREMENTS SPECIFICATION                            Doc ID: Glassware Washer
JETT                            Glassware Washer                                     URS_0

                                                                                     April 17, 2003



3.3     Interfaces
        The Programmable Logic Controller / Operator-Interface system (hereafter
        referred to as the “control system”) shall include interfaces with the Operators,
        Maintenance personnel, Supervisory personnel, external equipment, and the
        User’s building control system to ensure safe, reliable, continuous, and automatic
        operation and easy, safe, secure and reliable configuration.

        This section deals with the interfaces to the washer. Sections should deal with:
             -user security requirements
             -user titles and functions
             -interaction with other systems
             -interaction / setup of equipment

        3.3.1   User Interface
                The OIT shall incorporate a system for user identification and security as
                specified in CFR 21 Part 11. Each user who logs onto the system shall be
                clearly identified by their User ID.

                User access levels shall be defined below. The maximum number of each
                category is listed in the table. Functions available to each user level are
                marked with an X in the table.




                                                                                                            Administrator
                        Attribute / Functions
                                                                               Maintenance


                                                                                               Supervisor
                                                                 Operator




 Maximum # of users                                              10             5               5           1
 Start automatic operation                                       X             X               X
 Stop automatic operation                                        X             X               X
 Manually trigger I/O                                                          X               X
 Access I/O configuration screens                                              X               X
 Define recipes / cycle data                                                                   X
 Define users / user levels / passwords                                                                     X

Add columns and rows as necessary

Add requirements for security (formats, number of independent users, category types)


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           USER REQUIREMENTS SPECIFICATION                       Doc ID: Glassware Washer
JETT                     Glassware Washer                                 URS_0

                                                                      April 17, 2003

   3.3.2   Interface with Supervisory Systems
           Describe in detail the interaction the system has with Supervisory Systems.
           These systems include BAS, SCADA, MRP, etc. Details must include data
           to be transferred, transfer mechanism, data defaults, and configuration
           details. Reference any additional specifications to be included with this
           document.

           Example
           The washer system must integrate with the customer’s Building
           Automation System. The BAS shall indicate the following building
           conditions: Fire Alarm, Loss of HVAC, Drain Neutralization System
           Status. These conditions shall be transmitted to the washer via dry
           contacts on the BAS PLC. Connection to these contacts shall be by the
           customer.

   3.3.3   Interface with Peer Equipment
           Describe in detail the interaction the system has with any peer equipment.
           These systems include loaders / unloaders, conveyor lines, purified water
           systems, etc. Details must include handshaking data, transfer mechanism,
           data defaults, and configuration details. Reference any additional
           specifications to be included with this document.

           Example
           The washer system must communicate with the USP System PLC. The
           washer system shall indicate its request by sending a data signal via Data
           Highway Plus to the USP system. The USP system shall respond to the
           request by granting the USP token and opening the point-of-use valve.
           More details are shown in the USP System Communication Specification
           1.

   3.3.4   Interface with Equipment
           The control system shall include interfaces with external equipment to
           ensure safe, continuous, and automatic operation.

           Describe the I/O system that shall be used. If required, specify the control
           voltage (24VDC, 120VAC, etc). Detail any device level networks to be
           used (DeviceNet, Profibus, ControlNet).

           Example
           The control voltage shall be 24VDC. Analog devices shall be 4 – 20mA.
           Where possible, inputs and outputs shall be DeviceNet style. A DeviceNet
           scanner card shall be located in the PLC’s local rack.


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                  USER REQUIREMENTS SPECIFICATION                       Doc ID: Glassware Washer
JETT                             Glassware Washer                                URS_0

                                                                              April 17, 2003



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

      3.4.1       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.
                          Floor Loading is      pounds/ft2
                          See attached drawing #________________________ (if
                           applicable).
                  Layout is specific to the size equipment being used and system
                  requirements of the equipment.

      3.4.2     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


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               USER REQUIREMENTS SPECIFICATION                      Doc ID: Glassware Washer
JETT                          Glassware Washer                               URS_0

                                                                         April 17, 2003

                     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 (Oil tight)
                     NEMA 4 (Wash down)
                     NEMA 4X (Wash down and non-Corrosive)

   3.4.3       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 SPECIFICATION                      Doc ID: Glassware Washer
    JETT                            Glassware Washer                              URS_0

                                                                              April 17, 2003



4   CONSTRAINTS

    4.1   Milestone Schedule Requirements
          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. A more extensive timeline should be included in the Quality and Project
          Plan.

          The Supplier shall provide a written proposal within X weeks of receipt of this
          document at the Supplier’s local office.

          The Supplier shall provide a Functional Specification within X weeks of receipt
          of the purchase order.

          The User shall review, comment and/or approve, and return the Functional
          Specification to the Supplier within X weeks of receipt from the Supplier.

          The Supplier shall provide the Factory Acceptance Test Specification within X
          weeks prior to the scheduled date of the FAT.

          The User shall review, comment and/or approve, and return the test specifications
          to the Supplier within X weeks of receipt from the Supplier.

          The washer shall be delivered to the User’s receiving dock on or before XX / XX /
          XXXX.

          OR

               Written proposal / quote required date
               Purchase order will be placed by:
               Functional Specification delivery date:
               Factory Acceptance Test delivery date:
               Factory Acceptance Test approval date:
               Equipment is required on-site by:

          OR




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              USER REQUIREMENTS SPECIFICATION                     Doc ID: Glassware Washer
JETT                       Glassware Washer                                URS_0

                                                                       April 17, 2003




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 with Plant Control System
      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 SPECIFICATION                      Doc ID: Glassware Washer
JETT                       Glassware Washer                                 URS_0

                                                                        April 17, 2003

      The Supplier shall use a Manufacturer Model # Programmable Logic Controllers
      to control the washer system. A Type communication port shall be supplied for
      programming. The Supplier shall provide documentation that the application
      program was developed and coded using Manufacturer Program Name
      development and documentation software.

      The Supplier shall adhere to the following format for all instrument tags on the
      washer. Detail the format.

      The Supplier shall include the following information on all documents and
      drawings for the project. Detail the information.

4.4   Compatibility with Standard Components
      Include any requirements for preferred manufacturers. Include any special
      provisions for components not normally used in this type of application (example
      – heavy duty triclamps)

      The Supplier shall use reliable, commonly available, non-proprietary components
      that have been proven to be suitable for the intended service.

      If the User has any preferred components to minimize the User’s spare parts
      inventory, these items shall specified to the Supplier in the form of a User’s
      Preferred Vendor List.
      The Supplier shall make all possible attempts to use the User’s Preferred Vendor
      List3. Any deviations from the PVL should be first approved by the User.

4.5   Construction Compatibility
      All product contact parts shall be constructed from materials acceptable to the
      product and sterility assurance methods. Certificates for material, weld and finish
      shall be provided.

      Include any requirements for surface finish, diaphragm types, metal.

      Example
      All wetted surfaces shall be constructed of T316L stainless steel with a 15 Ra
      finish. Welds shall be continuous, and ground and polished to match the material
      surface finish.

      Process water piping shall be constructed of T316L stainless steel with a 15 Ra
      finish on the interior.

      Purified water piping shall be constructed of T316L stainless steel with a 15 Ra
      finish, electropolished on the interior.

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              USER REQUIREMENTS SPECIFICATION                        Doc ID: Glassware Washer
JETT                        Glassware Washer                                  URS_0

                                                                          April 17, 2003



      Teflon gaskets must be used.

      Exterior non-wetted surfaces shall be constructed of type 304 stainless steel with
      a #4 finish. Welds shall have color removed.

4.6   Building Compatibility
      To be able to be moved into the building, the Supplier must disassemble the
      washer so that its individual parts with a maximum length of X” long can fit
      through a X” wide by X” high door.

      Specify means by which washer will be reassembled, ie bolted and gasketed or
      welded.

4.7   Compatibility with Plant Utilities
      The User shall ensure that the following utilities are available and that the utility
      supply lines and piping are terminated with fittings or connections that are
      compatible with those listed below.

      The Supplier shall specify utility data, which is marked with an asterisk (“*”).

      Utility requirements, which are not specified or marked with an asterisk, shall be
      brought to the attention of the User. These requirements shall be approved by
      both the User and the Supplier before system design begins.

      Electrical – 3 / 60 Hz / 480 VAC 30 Amps
      Purified Water – USP 25 GPM @ 40 PSI @ 80C
      Potable Water – House 50 GPM @ 30 PSI @ 40C
      Steam – 60 PSI, Load *
      Compressed Air – Instrument Quality, 25 CFM @ 90 PSI
      Drain – 3”, 40 GPM maximum
      Exhaust – 12” Duct, ½” Static Pressure Drop

4.8   Availability
      The washer is intended to be operated X days per week, X hours per day. The
      maximum down time permitted for maintenance is X hours per day.

4.9   Procedural Constraints
      Describe any local procedural requirements such as local standards that must be
      adhered to. Attach a copy of those standards if possible.

      The washer shall be designed to meet cGMP 21 CFR part 210 and 211 as
      published at the time of order.

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       Controls for the washer shall meet the NFPA/NEC 70 and 79 for industrial
       machinery.

       Control panels for the washer shall meet the Underwriters Laboratories UL-508A
       certification for industrial equipment.

       The washer shall meet all applicable OSHA regulations for the safety of operators
       of equipment with regards to safety, guarding and noise.

       The washer shall meet CE requirements if delivered to the European Community.

       All piping welds shall meet ASME and 3A specification requirements.

       Other standards are attached. The Supplier shall adhere to the indicated sections
       only.

       Installation, operation, and maintenance instruction documentation for the system
       shall be design to be comprehendible by a high school graduate.

4.10   Maintenance Requirements
       Describe the expected hardware and software maintenance support including
       ease of maintenance, expansion capability (software only), likely enhancements
       (software only), expected lifetime and long-term support. Include the term of the
       standard support.




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5   LIFE CYCLE

    5.1   Development Procedures
          The project shall use the GAMP methodology when developing the system and
          documentation.

          Per GAMP, the Supplier shall provide a Quality and Project Plan as part of its
          proposal. The Supplier shall have a quality system in place. Internal quality
          procedures shall be available for the User’s review.

          The Supplier shall provide a Project Manager for the project to provide a single
          communication point with the User.

          Reference here any internal development procedures necessary. Show them as
          attachments or references.

    5.2   Testing Requirements
          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 machine performance, the User shall witness the execution of
          the approved Factory Acceptance Test procedures.

          The Supplier shall notify the User X weeks in advance of the start of this test.

          The User shall supply a sample of the items to be cleaned X weeks in advance of
          the start of this test. User shall supply material to be used to soil samples. User
          shall supply cleaning chemicals in sufficient quantities for testing.

    5.3   Delivery Requirements

          5.3.1   Delivery of System
                  The washer, with all options, equipment, and the documentation listed
                  below, shall be delivered to the User’s receiving dock by the date listed
                  above. Each crate shall be labeled with the equipment model and serial
                  number, Supplier’s name, project number and purchase order number.




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                        5.3.2   Delivery of Documents
                                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:
   Project Plan                                        Microsoft Word XX (*.doc)
   User Requirements Specification                     Microsoft Word XX (*.doc)
   Functional Specification/Requirement                Microsoft Word XX (*.doc)
   Design Specifications                               Microsoft Word XX (*.doc)
   Controls Test                                       Microsoft Word XX (*.doc)
   Hardware Installation Test                          Microsoft Word XX (*.doc)
   Operational Test                                    Microsoft Word XX (*.doc)
   Factory Acceptance Test                             Microsoft Word XX (*.doc)
   Operator, Maintenance and Service Manuals           Microsoft Word XX (*.doc)
   Process and Instrumentation Diagram (P&ID)          AutoCAD version XX.X (*.dxf)
   Instrument Listing                                  Microsoft Word XX (*.doc) or Excel XX (*.xls)
   Control Schematics                                  AutoCAD version XX.X (*.dxf)
   Control Panel Assembly Drawings                     AutoCAD version XX.X (*.dxf)
   Equipment Assembly Drawings                         AutoCAD version XX.X (*.dxf)
   Bill of Materials                                   Microsoft Word XX (*.doc) or Excel XX (*.xls)
   Spare Parts List                                    Microsoft Word XX (*.doc) or Excel XX (*.xls)

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   Component Cut Sheets                            Microsoft Word XX (*.doc) or Excel XX (*.xls)
   CONTROL PLATFORM Program Printout and           XXX Program Development format
    Disk File

   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.

                    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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                     USER REQUIREMENTS SPECIFICATION                      Doc ID: Glassware Washer
  JETT                            Glassware Washer                                 URS_0

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6 GLOSSARY
 If necessary, attach a glossary that includes definitions of terms that may be unfamiliar to the
 Supplier or terminology which have meanings specific to entries on this User Requirements
 Template

 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.
 PLC                       Programmable logic controller
 OIT                       Operator interface terminal
 GAMP                      Good Automated Manufacturing Practice. 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.
 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.




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7 REFERENCE DOCUMENTS
 List is a list of all documents referenced in the URS. Include all additional specifications
 from engineering companies, validation plans, drawings, etc.

 Be aware that documents not listed here may be lost and not referenced in the corresponding
 specifications from the Supplier.

 List references that were used in preparing this document or provide additional details.
 Examples are User’s project schedule, the GAMP guide, etc.




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                   USER REQUIREMENTS SPECIFICATION                    Doc ID: Glassware Washer
  JETT                          Glassware Washer                               URS_0

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8 APPROVALS
 Insert your company’s standard approval page at the appropriate position in the document
 or use 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.

 Reviewed and Approved by _________________________________                   __________
                                 User Project Manager                            Date


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

 Reviewed and Approved by _________________________________                   __________
                                Supplier Project Manager                         Date




                  JOINT EQUIPMENT TRANSITION TEAM

				
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