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Doc ID: DT001urs_A
USER REQUIREMENTS Depyrogenation Tunnel
JETT SPECIFICATION Rev. 1
Depyrogenation Tunnel
October 2003

USER REQUIREMENTS TEMPLATE
FOR A
DEPYROGENATION TUNNEL

JOINT EQUIPMENT TRANSITION TEAM

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Doc ID: DT001urs_A
USER REQUIREMENTS Depyrogenation Tunnel
JETT SPECIFICATION Rev. 1
Depyrogenation Tunnel
October 2003

REVISION HISTORY

Rev. Date Approval Revision Summary
1 10/29/2003 Petro Revised items 3.4.2.2 & 3.4.3.2 – Corrected the average
airflow velocity rates. The rate was listed as typically 50
m/sec. The value was corrected to be 0.5 m/sec.
0 09/15/2003 Petro Initial Release

(Reminder of Page Intentionally Left Blank)

JOINT EQUIPMENT TRANSITION TEAM

................................4 AVAILABILITY ..................... 7 3.....................3 DELIVERY .....................................1 CAPACITY .............................................. 23 5............ 20 4.......................................................................................6 MAINTENANCE .........................2 PROCESS REQUIREMENTS .. 15 4...4 SUPPORT .0 OPERATIONAL REQUIREMENTS .0 OVERVIEW ...................................................................................................................0 LIFE-CYCLE .....................................................................................1 DEVELOPMENT ........................................................................................................................................................3 PROCESS CONTROL .4 FUNCTIONS .. 18 4................................................................................. 6 3............5 PROCEDURAL CONSTRAINTS .... 17 4................................5 DATA AND SECURITY ..........................................................................2 EQUIPMENT CONSTRAINTS .........................................................0 GLOSSARY........................... 4 2............................................ 18 4............................................................ 25 7.................................................................................................. 22 5...................................................................................... 24 6.......................................................................3 COMPATIBILITY AND SUPPORT ........................................................................................................0 APPROVAL ................. 5 3...................... 22 5......... 20 4.......................................................... 21 5................. 5 3.......................................................... 27 8........................ 22 5..............................0 CONSTRAINTS................................................. 5 3.....2 TESTING ............................. 1 Depyrogenation Tunnel October 2003 TABLE OF CONTENTS 1..................................................................................................................................................................................... 17 4.................................................... 5 3.......................... 13 3......................................................................0 REFERENCES ..............................................................1 MILESTONES AND TIMELINES ............... 28 JOINT EQUIPMENT TRANSITION TEAM ............................................................ Page 3 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev..........6 ENVIRONMENT........0 INTRODUCTION...................

Page 4 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. The equipment supplier or vendor has specific responsibilities as outlined by the Validation Plan and this document. This URS will be recognized as an integral part of the procurement agreement with the selected equipment vendor.: Depyrogenation Tunnel Model # 1234 Document No. The depyrogenation tunnel will be located in a ___________________ operating area within a cGMP packaging operation. The URS is then provided to the Supplier to provide a price quote for the depyrogenation tunnel supply including the design and manufacture of the equipment. 1 Depyrogenation Tunnel October 2003 Project No. variables and options necessary to procure a functional depyrogenation system that meets the users needs in the most cost-effective method possible.0 INTRODUCTION This document was generated under the authority of the ___________________ Company for the purpose of specifying the user requirement for a depyrogenation tunnel that will sterilize and depyrogenate a wide range of vial sizes in a pharmaceutical environment. This plan has been included as Attachment _____.: 8111234567 Document Description: Depyrogenation Tunnel User Requirements Spec. An equipment validation plan has been developed to outline the planned tasks and expectations for validation of the depyrogenation tunnel. The depyrogenation tunnel will be interfaced to the output of a vial washer and the input to a filling system. The User Requirements Specification (URS) is provided to aid the user through the important components. 1. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the ____________________ Company. JOINT EQUIPMENT TRANSITION TEAM .

ampoules.  Pressure balance within the tunnel will allow the air to flow from the output (filler) area to the cool down zone.  The throughput of this tunnel will be identified in the commodity table in section 3. and from the heat zone within the tunnel to both the infeed (washer) zone.4. cartridges.0 OPERATIONAL REQUIREMENTS 3. JOINT EQUIPMENT TRANSITION TEAM .0 OVERVIEW The depyrogenation tunnel shall process pharmaceutical vials under sanitary conditions with the following functions:  Vial depyrogenation  Vial transport  Other (specify): 3. and to the cool down zone. 3.2 Process Requirements  The time that the commodity is in the heat zone will be adjustable. syringes) in a size range from ___ml to ___ml will be depyrogenated in this tunnel. (Typically within 60 minutes)  The airflow through the tunnel will be in a generally unidirectional pattern from the filters to the return air ducts (top to bottom). 1 Depyrogenation Tunnel October 2003 2.1. (Typically in the range of 90- 180 minutes)  The depyrogenation tunnel must be able to change to a different setpoint temperature within ________ minutes. Page 5 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. (Typically in the range of 350C)  The depyrogenation tunnel must be able to reach the setpoint temperature within _________ minutes.1 Capacity  Glass _____(vials.4.  The setpoint temperature of the heating zone in the tunnel will be adjustable to a maximum of _________ C.

1 Room Degrees Temperature 100 .5 .1 Room Heat Zone Differential Pressure to Washer/Tunnel 0. Page 6 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev.5 .0 Celsius Cool Down Zone Differential Pressure to Washer/Tunnel 0.0 Temperature Celsius JOINT EQUIPMENT TRANSITION TEAM .5 Pascal 0.5 Pascal 0.  Process Critical Values of a depyrogenation tunnel.5 Pascal 0. temperature and pressure balance within the different zones.3 Process Control  Process parameters that are controlled are: Conveyor belt speed.1 Room Sterilization Degrees 100 – 250 5. Unit of Parameter Range Measuremen Tolerance t Conveyor Belt Speed 50 – 200 mm/minute N/A Infeed Zone Differential Pressure to Washer/Tunnel 0.5 . 1 Depyrogenation Tunnel October 2003 3.350 5.

3 The tunnel will not experience more than ____% (Typically 90-95%) downtime at production speeds defined in the commodity table below.1 Glass commodities are transferred through the tunnel without contamination.4 Commodity Table Tubular Commodity Vial Vial Rate or Volume Weight Height Comments Type OD ID (V/Min) Molded JOINT EQUIPMENT TRANSITION TEAM .1 General Considerations The depyrogenation tunnel is expected to satisfactorily depyrogenate and transfer glass commodities at production rates defined in the commodity table below.1.1.1. 1 Depyrogenation Tunnel October 2003 3.4. or breakage.4.4 Functions 3. Satisfactory performance is defined by the following criteria.4.2 Glass commodities are depyrogenated to provide a _____-log reduction in pyrogens.4. disorienting. 3. 3. Provide a plan to clear the glass from the outfeed at the end of a batch. 3.4. (Typically 3-log) 3.1. Page 7 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev.

and the external room environment. are depyrogenated.1. The vials are then transported through the heat zone. Page 8 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev.1. The tunnel conveyor belt shall not be allowed to restart without operator intervention. 3.4.6 Controls: The depyrogenation tunnel shall be operable by one person.7 Pressure Balance: The differential air pressure in the heat zone must always be positive relative to the cool down zone. 3. infeed zone. 12-20 Pa) Transition gates are required between the infeed zone and the heat zone.5 Vial Handling: Vials are received from the washer output deadplate and fed onto the tunnel conveyor belt. 2Pa) Heat Zone ________ Pascal (Typ. The tunnel will have a night mode that will allow an energy- efficient mode of operation to hold temperature and sterility of the tunnel between batches.4. with safety related faults stopping the tunnel conveyor belt immediately.4. These gates are _________ (fixed. automatically adjustable) in height.2 Infeed Zone Glass enters the tunnel belt and is spread to the width of the tunnel belt.4. 3.1.1. 3.8 Access Ports: Each zone will have access ports above the HEPA/ULPA filtration to allow for filter integrity testing without disassembly of the equipment. and between the heat zone and the cool down zone. 3. cooled down and fed onto the outfeed deadplate. in conjunction with the washer.4.4. manually adjustable.1. 3Pa) Filling Suite ________ Pascal (Typ. 4Pa) Cool Down Zone ________ Pascal (Typ.9 Instrumentation: Industry standard instrumentation and display devices will monitor all process critical parameters. The emergency-stop function does not stop the fans or heaters of the tunnel. 1 Depyrogenation Tunnel October 2003 3. The differential pressure setpoints are: Infeed Zone ________ Pascal (Typ. JOINT EQUIPMENT TRANSITION TEAM .

3.4. Page 9 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev.1 Temperature: No temperature control is provided in the infeed zone. and +/.3 Heat Zone: The glass is transferred into the heat zone where the temperature is controlled to a level capable of providing the required thermal activation factor (FH).) Fresh air is provided to the inlet of the HEPA filter through a roughing filter. The temperature uniformity / distribution measured above the conveyor in the empty tunnel should be within the range of +/. JOINT EQUIPMENT TRANSITION TEAM .4.4. 3. 1 Depyrogenation Tunnel October 2003 3. The FH provides the necessary temperature and time to ensure the required ___log endotoxin reduction specified. as measured in line across the belt.5 m/sec. recording and alarming capabilities will monitor temperature. The FH calculation must be provided as an appendix at the end of this document. and is delivered from the HEPA air filter at a rate of ______meters/sec.2. A differential pressure device with display and alarming capabilities will monitor the differential pressure between the internal zone and the outside room pressure._____C (Typically 5C) of the average.1 Temperature: The temperature within the heat zone must be adjustable in 5C increments from ambient to a maximum of 350C.2. but a limited amount of heated air from the heat zone passes into the infeed zone. recording and alarming capabilities will control and monitor temperature. A temperature measuring transmitter with display. Exhaust air exits the Infeed Zone through a duct to the outside of the washer/tunnel room.2 Air Flow: The glass is subjected to unidirectional air flow consistent across the width of the zone. as measured in line across the belt. This begins to raise the temperature of the glass prior to entering the heat zone._____C (Typically 10C) for molded glass as an average.4. 3. Air is not recirculated. The temperature uniformity / distribution measured inside of the commodity should be within the range of +/. Air velocity is maintained to +/-20% of the average airflow. A temperature measuring transmitter with display. (Typically 0. 3._____C (Typically 5C) for tubing glass.

3. but exhausted out a vent in the top of the tunnel.5 m/sec.4. Fresh air is provided to the inlet side of the HEPA filter through a roughing filter. Fresh air is provided to the inlet side of the HEPA filter through a roughing filter.4. Fresh air is used to make-up air that is lost to the adjacent zones through the gates. (Typically EU class B) 3.3 Room Classification: The air quality in the heat zone is ________.4. Air is not recirculated. recording and alarming capabilities will monitor the differential pressure between the internal zone and the outside room pressure. Air velocity is maintained to +/-20% of the average airflow. 3. Air velocity is maintained to +/-20% of the average airflow and passes through the HEPA air filter at a rate of ______meters/sec. The air can be additionally cooled using cooling coils and chilled water as a media. There is no exhaust in the heat zone. A temperature measuring device with display. JOINT EQUIPMENT TRANSITION TEAM .2 Air Flow The glass is subjected to unidirectional air flow consistent across the width of the zone.4 Cool Down Zone: The glass is transferred to the cool down zone where the glass is cooled down gradually to near ambient temperatures to prevent cracking of the glass. and is recirculated through the HEPA air filter at a rate of ______meters/sec(Typically 0. A differential pressure device with display and alarming capabilities will monitor the differential pressure between the internal zone and the washer/tunnel room pressure.4. Cooling of the vials is accomplished using fresh HEPA filtered air.3.1 Temperature Control: The temperature of the glass must be cooled down to a maximum of ________C at the exit of the tunnel. A differential pressure device with display. or damage to the outfeed guides due to high temperatures.4.4. 3. 3. Page 10 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev.4. 1 Depyrogenation Tunnel October 2003 3. recording and alarming capabilities will monitor temperature.).2 Air Flow: The glass is subjected to laminar air flow consistent across the width of the zone.

Page 11 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. the system shall protect in the following priority:  Personnel  Equipment  Product Recovery Methods:  Manually evacuate and discard all glass on the conveyor belt  Re-start based on last state before loss of power. Heating. (System runs through power recovery sequence when operator start signal is given)  If there is an automatic batch reporting system. (Typically EU class B) 3.4.4.5 Power failure/Recovery In the event of a power failure. the information shall be retained in the event of a power failure (A UPS is required for automatic batch reporting systems for data retention). aeration and testing procedures. gas. recirculation and exhaust of the sterilization cycle must be permanently designed into the system. For vaporized hydrogen peroxide. a minimum cycle of _____ C for at least _____ minutes is required.4. (Typically 170C for 60 minutes (Compendia for Dry Heat Sterilization)) Air must be circulated throughout the cool down zone for the complete sterilization cycle.4. the complete cycle must be provided. 3. including the heating. and the entire classified air path must be able to be sterilized using either vaporized hydrogen peroxide or dry heat adequate to achieve sterilization. For dry heat.4. 1 Depyrogenation Tunnel October 2003 3.3 Room Classification: The air quality in the cool down zone is ________. JOINT EQUIPMENT TRANSITION TEAM .4 Cool Down Zone Sterilization: The cool down zone.

and notify the operator once stopped.6 “Emergency Stop” The system shall have an E-Stop mechanism designed to stop the conveyor belt and gates immediately. JOINT EQUIPMENT TRANSITION TEAM . The E-Stop mechanism(s) shall be located in easily accessible areas around the equipment as required by national and local safety standards. Non-Critical warnings and will illuminate the alarm indicator but allow the system to continue to operate. The fans and heaters do not stop during Emergency stop.1 “Critical alarms” shall take action automatically to shut the equipment down and notify the operator.7 Alarms and Warnings 3.4. Once the alarm is reset. and the alarm indicator shall be extinguished when the warning condition disappears. 3.4. the operator may restart the system.2 “Non-Critical alarms” shall take action to shut the equipment down at the end of the cycle. 3.7. The operator shall be required to acknowledge the alarm before the alarm can be reset and the system restarted. Once the alarm is reset. 1 Depyrogenation Tunnel October 2003 3.4. 3.4. Page 12 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev.3 “Operator Alert” shall notify the operator and take no further action.7.7. the operator may restart the system. The operator shall be required to acknowledge the warning in order to silence the alarm horn. The operator shall be required to acknowledge the alarm before the alarm can be reset and the system restarted.4.

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.1 User Interfaces This section should address the following issues:  User interface access levels  Frequency of data point collection JOINT EQUIPMENT TRANSITION TEAM . The supplier shall stipulate the methods by which this criterion is met. request the supplier to submit the complete alarm list and differentiate between critical and non-critical alarms.5. For a standard equipment type application. 3. 1 Depyrogenation Tunnel October 2003 Non. 3. Page 13 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. A complete alarm list will be developed and included in the Functional Specification document. Response Critical Informational Alarm or Informational Message Critical Operator Alarm Message Interlock(s) Alarm Procedural Emergency Stop X X Control Platform Communication X X Watchdog Control Power Fault X X Heat Zone High Temperature Fault X X XXXX X X YYYY X X ZZZZ X X Motor Faults X X CONTROL PLATFORM Battery Low X Warning The list of critical alarms in the table is not intended to be a comprehensive list of all alarms for the system.

2 User Interface with Supervisors and Operators The control platform shall include interfaces with the Operator and Supervisor that ensures easy. indicators. Page 14 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. Spanish. (English.5.3.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. For example:  A Data Highway Plus communications port shall be provided.5.3 Interface with Other Equipment The control system shall include the interfaces necessary to facilitate operation and configuration. 3.2. 1 Depyrogenation Tunnel October 2003  Hardcopy/electronic data collection requirements  Compliance with 21CFR Part 11 (for Europe .1 Language requirements are ___________. French. This panel shall provide the necessary switches.5. 3.2 Displayed Requirements: See table in section 3. German. An operator-interface panel shall be provided and mounted near the equipment or on the equipment. safe. User ID and password provide security for data and operator access.  A Modem communications port shall be provided.5. 3. and reliable operation. and devices to operate the equipment. Etc. JOINT EQUIPMENT TRANSITION TEAM .) 3.2.

No data access or transfer rights.4. 3.5.4 Security Levels (Modify as required for specific equipment) 3.3 Maintenance: Operational access.1 Supervisory: Data access only.4. stop.  Critical process parameters are processed and available through the control PLC. Maintenance and set-up access including change parameters.5. Page 15 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. 3.5.6.5 Data Collection  Critical process parameters are recorded on a permanent chart recorder. The following shall be recorded:  Temperature for each zone  Differential Pressure for each zone  Belt speed 3. Data is available to a supervisory system via the data highway connection. No operational or maintenance/set-up access allowed. including start.  No electronic data storage provided on this control system. reset and fault correction.5. No maintenance or set-up access allowed.5. set-ups and adjustments and diagnostics.1 Layout  Allocated floor space for the equipment is _____ inches by ________ inches with at least a _______inch corridor around the periphery for the equipment. reset and fault correction.  Vertical clearance is _________ inches. including approvals and transfer of data to hierarchical systems. and also displayed on the same recorder. 3. stop.4. including start. No data transfer allowed.6 Environment 3.2 Operator: Operational access only. 1 Depyrogenation Tunnel October 2003 3.  See attached drawing #________________________ JOINT EQUIPMENT TRANSITION TEAM .

6. Page 16 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev.2 Class _________.3 Sterilization Requirements – Refer to section 3.6. 4.2.2 Physical Conditions 3. 2.6. BL-2 or BL- 3) 3.2.6.5 Cleaning Requirements ________.4 3. (hand wash. (Typically NEMA 12 or IP 54) 3. (Typically BL-1.6. The Seismic Zone in the operating environment is zone (1.6.3 Biohazard Level __________. or 4A).4 Intended Operating Environment: The depyrogenation tunnel shall be mounted in a GMP environment with a temperature range of 15 to 25 °C.2. spray down. 3.2. non- condensing humidity. 3. JOINT EQUIPMENT TRANSITION TEAM . automatic) 3.6. Vibration levels in operating environment are negligible.1 Room will be non-hazardous 3.4 Enclosure Rating __________.4. 1 Depyrogenation Tunnel October 2003 Layout is specific to the size equipment being used and system requirements of the equipment.2. (Typically EU Class D or C) 3.4.6.

Functional Specification Proposal Analysis (Traceable to URS) Approval Detailed Design Review Functional Specification Documentation (traceable to Functional Specification) Approval Review Detailed Design System Acceptance Test Specifications (IQ/OQ) • Hardware • Software Review System Approv Acceptance Test Specifications al System Acceptance Testing and Results (User Witness Optional) Integrate with Validation Documentation (as appropriate) Maintenance & Support Documentation JOINT EQUIPMENT TRANSITION TEAM .0 CONSTRAINTS 4.O. 1 Depyrogenation Tunnel October 2003 4. Page 17 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev.1 Milestones and Timelines Based on the model outlined below. establish the project milestones with a timeline: “BASELINE” EQUIPMENT ACQUISITION MODEL USER/(CONSULTANT if applicable) SUPPLIER Master Validation Plan User Audit of Supplier • User Initiates Equipment Validation Plan RFQ • Explanation to Supplier Proposal (Living Document) RFQ • Quality Plan l • Project Plan User Requirements Specification (URS) p osa o (Living Document) Pr P.

Refrain from driving the supplier into customizing his equipment package.2.2. 4.2 Preferred Vendor List If necessary attach any critical preferred vendors. Heating and Cool Down Zones. Indoor Temperature: C Exhaust air will exit from the cool down zone at a temperature not to exceed __________C 4. If the vendor wishes to deviate from the Preferred Instrumentation List.2 HVAC Equipment Constraints Process air is to be provided at the Infeed.1 Environmental Conditions The depyrogenation tunnel is to be used at the following environmental conditions: Altitude ________ ft above sea level 4.1 Control Platform Controllers The Supplier shall utilize Control Platform Controllers that shall include a communications port.2. Page 18 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. 4. JOINT EQUIPMENT TRANSITION TEAM . 1 Depyrogenation Tunnel October 2003 4.3 Equipment Generated Vibration The maximum allowable equipment vibration generated during operation is _________. along with an explanation of why the deviation is recommended.2 Equipment Constraints 4. a listing of the proposed components and instrumentation sub-vendors indicating type and model numbers shall be submitted with the quotation.3.3.3 Compatibility and Support 4. The Supplier shall provide documentation that the program (embedded software) was developed and coded utilizing program development and documentation software.

which are compatible with those described on the Customer Connection Drawings. 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. The Supplier shall specify utility data. Page 19 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. Base Utilities Worksheet Related Discharges  Volume  pH  Temperature  Materials Chilled Water  Volume  pH  Temperature Air Exhaust  Volume  Locations  Temperature  Contaminants JOINT EQUIPMENT TRANSITION TEAM . which are not specified or marked with a triangle. Utility data.3 Utilities The utilities and space involved needs to be discussed prior to purchasing the equipment.3. shall be brought to the attention of the User. Obviously. The unit and its support equipment must be able to be installed in current building facilities. the actual equipment size is but a small part of the entire scope of work necessary to implement a larger system. 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 is marked with a triangle. 1 Depyrogenation Tunnel October 2003 4.

1 Depyrogenation Tunnel October 2003 Electricity  ______ VAC ____ Hertz  Phases  Amperage  Uninterruptible Power Supply (Define Use) Control Air  Pressure For example: _______ PSIG (must be clean. Operation of the depyrogenation tunnel shall be suspended. roughness. JOINT EQUIPMENT TRANSITION TEAM . unless specified. All piping welds shall meet ASME or 3A specification requirements. 4. etc. dry ISA instrument quality air. capacity to be determined by size of equipment).4 Availability The depyrogenation tunnel is intended to be operated continuously in either production mode or night mode. Other Utility Requirements Provide details regarding any other utility systems that are required to support operation of the equipment/system.5 Procedural Constraints 4.5. 4.1 Product Contact Materials Describe any local procedural requirements such as local standards. Recommend at least 90 PSIG constant air pressure for all equipments. which must be adhered to if applicable. Page 20 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. and the system shall be available for preventative maintenance or routine service as required. List critical requirements for surface finish.

5.4 EMI / RFI levels are: The depyrogenation tunnel will be used in an area where two- way radio communication devices are in operation.5.5. expansion capability (software only). 1 Depyrogenation Tunnel October 2003 Other standards are attached.5 Containment Not Applicable 4. System shall be maintained on a schedule as indicated by the supplier. 4.5. expected lifetime and long-term support. A comprehensive lubrication list and recommended lubrication schedule JOINT EQUIPMENT TRANSITION TEAM .2 Product in Contact with Materials Not Applicable 4.6 Labeling All equipment and control wiring shall be labeled and identified.5. All sub-systems provided (Maintenance and operation manuals of vendor equipment) 2.3 Noise Level Constraints The noise level generated during operation of the depyrogenation tunnel will not exceed 85 dB from a distance of 3 feet at 5 feet high from the floor. 4. The depyrogenation tunnel shall meet CE requirements for electrical noise immunity and emissions. Tag numbering shall be consistent between the devices and all corresponding documentation. likely enhancements (software only). Page 21 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. The Supplier shall adhere to the indicated sections only. Supplier is to provide (at minimum) the following maintenance instructions: 1. 4. 4.6 Maintenance Describe the expected hardware and software maintenance support including: ease of maintenance.

integration testing. it should be referenced in this section of the document. A comprehensive recommended maintenance (regular recommended inspection intervals. recommended spare parts list) 4. Supplier shall supply ______ Copies of Operation. 1 Depyrogenation Tunnel October 2003 3. JOINT EQUIPMENT TRANSITION TEAM . Installation. wear points. etc. special tests. Ability to remove and replace the conveyor belt within _______ minutes without moving adjacent equipment. Accessibility for operation and maintenance personnel.2 Testing Describe the Supplier testing requirements. A minimum of _______ weeks shall be allowed for the User to review and to comment and/or approve the Factory Acceptance Test Specification. etc. The Supplier shall notify the User _______ weeks in advance of the start of this test.1 Development If S88 is to be applied to the equipment being acquired. the User shall witness the execution of the Factory Acceptance Test procedures. 5. Maintenance and de-commissioning manuals 5. In order to verify system performance. The Supplier shall provide a Project Manager for the project to provide a single communication point with the User. The Factory Acceptance Test Specification shall be submitted to the User for review and approval prior to execution. Factory Acceptance Test. Reference the Validation Test Plan. The project shall utilize the GAMP methodology when developing the system and documentation. Page 22 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. Internal quality procedures shall be available for the User’s review. 5. This section should also include required amount of demonstrated run time. The Supplier shall have a quality system in place. 6.0 LIFE-CYCLE 5. The Supplier shall provide a Quality and Project Plan as part of their proposal. any special materials necessary to complete testing. Refer to the Equipment Validation Plan for applicable procedures.

1 Documentation Installation.doc)  Factory Acceptance Test Microsoft Word XX (*.doc)  Functional Specification/Requirement Microsoft Word XX (*. and maintenance instruction documentation for the system shall be developed to a level that is comprehensible to a high school graduate. 5. equipment. to produce the documentation. All final documents and drawings shall reflect “as-built” condition.doc)  Operator.3 Delivery The depyrogenation tunnel. Page 23 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. operation. Maintenance and Service Manuals Microsoft Word XX (*. shall be delivered to the User’s receiving dock. and the documentation listed below. All final documents shall be shipped with transmittals that identify them as contractually required documents.doc)  Controls Test Microsoft Word XX (*.dxf) JOINT EQUIPMENT TRANSITION TEAM . The Supplier shall use the formats described in the GAMP Supplier Guide.X (*.doc)  User Requirements Specification Microsoft Word XX (*.3. 1 Depyrogenation Tunnel October 2003 5. Current Version. with all options. The Supplier shall provide the documentation for preliminary review.doc)  Hardware Installation Test Microsoft Word XX (*.doc)  Operational Test Microsoft Word XX (*.doc)  Design Specifications Microsoft Word XX (*.doc)  Process and Instrumentation Diagram (P&ID) AutoCAD version XX. The Supplier shall provide documentation reflecting “as- built” condition with final delivery. 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 (*.

dxf)  Bill of Materials Microsoft Word XX (*. 5.4.1.1 Training (list training options available) 5.2 User Site Support Preventative Maintenance (list maintenance contracts available) System Improvements (supplier shall notify user of any improvements available on a regular basis) JOINT EQUIPMENT TRANSITION TEAM .X (*.doc) or Excel XX (*.dxf)  Equipment Assembly Drawings AutoCAD version XX. The paragraphs outlined below provide some areas for consideration.xls)  Component Cut Sheets Microsoft Word XX (*. 1 Depyrogenation Tunnel October 2003  Instrument Listing Microsoft Word XX (*.X (*.4.doc) or Excel XX (*.2.4 Support Describe what support activities are required after acceptance.2 Post Start-up Support (list post-startup support available) 5.1 Technical Support Telephone (Voice or Modem) Replacement Parts Availability List (Normal lead times shall be listed) 5.xls)  Control Schematics AutoCAD version XX.xls)  CONTROL PLATFORM Program Printout and XXX Program Development format Disk File  OIP Configuration Printout and Disk File XXX Program Development format 5.4.1 Start-up Support (list available options) 5.2. Page 24 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev.doc) or Excel XX (*.4.doc) or Excel XX (*.X (*.4.xls)  Spare Parts List Microsoft Word XX (*.dxf)  Control Panel Assembly Drawings AutoCAD version XX.

and Air Conditioning ISA Instrument Society of America ISO International Organization for Standardization JETT Joint Equipment Transition Team LEL Lower Explosion Limit NEMA National Electrical Manufacturers Association OIP Operator Interface Panel Pa Pascal PLC Programmable Logic Controller JOINT EQUIPMENT TRANSITION TEAM . attach a glossary. 1 Depyrogenation Tunnel October 2003 6. For example (example list is not intended to be complete): Acronym Definition C Degrees Celsius BL Biohazard Level CE Common European Standards CFR Code of Federal Regulations cGMP current Good Manufacturing Practices dB Decibels E-stop Emergency Stop button EMI Electro-Magnetic Interference FH Thermal Activation Factor ft Feet GAMP Good Automation Manufacturing Practices GUI Graphic User Interface HEPA High Efficiency Particulate Air filter HMI Human – Machine Interface HVAC Heating.0 GLOSSARY If necessary. Ventilation. Page 25 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. which includes definitions of terms that may be unfamiliar to the Supplier or terminology that may have meanings specific to entries on this User Requirements Check sheet.

Page 26 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. 1 Depyrogenation Tunnel October 2003 Acronym Definition PSIG Pounds/Square Inch Gage RFI Radio Frequency Interference S88 Batch Operations Standards URS User Requirement Specification ULPA Ultra Low Penetration Air filter VAC Volts Alternating Current JOINT EQUIPMENT TRANSITION TEAM .

Page 27 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. such as:  Equipment Validation Plan  Current revision of GAMP Guidelines  Vendor Piping Certification (if applicable)  Customer Connection Diagram  Approved Instrumentation List  Process Flow Diagram  21 CFR Part 11  National Electric Code  S88 JOINT EQUIPMENT TRANSITION TEAM . 1 Depyrogenation Tunnel October 2003 7.0 REFERENCES List references that were used in preparing this document or that provide additional details.

Page 28 of 28 Doc ID: DT001urs_A USER REQUIREMENTS Depyrogenation Tunnel JETT SPECIFICATION Rev. The approval process/requirements should be outlined in the Equipment Validation Plan. 1 Depyrogenation Tunnel October 2003 8. JOINT EQUIPMENT TRANSITION TEAM . etc. Printed/Typed Name Signature Date Other approvals as necessary may be included. Printed/Typed Name Signature Date This document has been reviewed by the Supplier Project Manager and approved for use by the Supplier Project Team.0 APPROVAL Insert your company’s standard approval page at the appropriate position in the document or utilize the sample approvals listed below. Engineering. Printed/Typed Name Signature Date This document has been reviewed by the User Quality Assurance Group and approved for use by the Supplier. User Groups. as required. This document has been reviewed by the User Project Manager and approved for use by the Supplier. such as the Technical Services Groups.