De Pyro Ge Nation Urs
Short Description
Pyro Ge Nation Urs...
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JETT
USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
USER REQUIREMENTS TEMPLATE FOR A
DEPYROGENATION TUNNEL
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USER REQUIREMENTS SPECIFICATION
Doc ID: DT001urs_A Depyrogenation Tunnel 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)
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USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
TABLE OF CONTENTS 1.0
INTRODUCTION..............................................................................................4
2.0
OVERVIEW........................................................................................................5
3.0 OPERATIONAL REQUIREMENTS...............................................................5 3.1 CAPACITY.........................................................................................................5 3.2 PROCESS REQUIREMENTS...............................................................................5 3.3 PROCESS CONTROL.........................................................................................6 3.4 FUNCTIONS.......................................................................................................7 3.5 DATA AND SECURITY.....................................................................................13 3.6 ENVIRONMENT...............................................................................................16 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.........................................................................................................25 6.0
GLOSSARY......................................................................................................26
7.0
REFERENCES.................................................................................................28
8.0
APPROVAL.......................................................................................................29
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Depyrogenation Tunnel
Project No.:
Depyrogenation Tunnel Model # 1234
Document No.:
8111234567
Document Description:
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
Depyrogenation Tunnel User Requirements Spec.
1.0 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. The User Requirements Specification (URS) is provided to aid the user through the important components, variables and options necessary to procure a functional depyrogenation system that meets the users needs in the most cost-effective method possible. 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. This URS will be recognized as an integral part of the procurement agreement with the selected equipment vendor. 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. The depyrogenation tunnel will be interfaced to the output of a vial washer and the input to a filling system. The depyrogenation tunnel will be located in a ___________________ operating area within a cGMP packaging operation. An equipment validation plan has been developed to outline the planned tasks and expectations for validation of the depyrogenation tunnel. This plan has been included as Attachment _____. The equipment supplier or vendor has specific responsibilities as outlined by the Validation Plan and this document.
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Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
2.0 OVERVIEW The depyrogenation tunnel shall process pharmaceutical vials under sanitary conditions with the following functions:
Vial depyrogenation Vial transport Other (specify):
3.0 OPERATIONAL REQUIREMENTS 3.1
Capacity
3.2
Glass _____(vials, ampoules, cartridges, syringes) in a size range from ___ml to ___ml will be depyrogenated in this tunnel. The throughput of this tunnel will be identified in the commodity table in section 3.4.1.4.
Process Requirements
The time that the commodity is in the heat zone will be adjustable. The setpoint temperature of the heating zone in the tunnel will be adjustable to a maximum of _________ C. (Typically in the range of 350C) The depyrogenation tunnel must be able to reach the setpoint temperature within _________ minutes. (Typically in the range of 90180 minutes) The depyrogenation tunnel must be able to change to a different setpoint temperature within ________ minutes. (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). Pressure balance within the tunnel will allow the air to flow from the output (filler) area to the cool down zone, and from the heat zone within the tunnel to both the infeed (washer) zone, and to the cool down zone.
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3.3
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1
USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
October 2003
Process Control
Process parameters that are controlled are: Conveyor belt speed, temperature and pressure balance within the different zones. Process Critical Values of a depyrogenation tunnel. Unit
Toler Param et er
Convey or B el t S p ee d Infeed Z o n e Differe nt ia l
Rang
mm/m 50 – N/A
0.5 - 5
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Pascal
0.1
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Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1
USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
October 2003
Pr es su re to W as h er /T u n n el R o o m Heat Z o n e Differe nt ia l Pr es su re to W as h er /T u
0.5 - 5
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Pascal
0.1
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Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1
USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
October 2003
n n el R o o m Degre
Temper at ur e
100 5.0
Cool D o w n Z o n e Differe nt ia l Pr es su re to W as
0.5 - 5
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Pascal
0.1
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Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1
USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
h er /T u n n el R o o m Steriliz at io n T e m p er at ur e
October 2003
Degre
100 –
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5.0
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3.4
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1
Depyrogenation Tunnel
October 2003
Functions 3.4.1
General Considerations The depyrogenation tunnel is expected to satisfactorily depyrogenate and transfer glass commodities at production rates defined in the commodity table below. Satisfactory performance is defined by the following criteria. 3.4.1.1 Glass commodities are transferred through the tunnel without contamination, disorienting, or breakage. Provide a plan to clear the glass from the outfeed at the end of a batch. 3.4.1.2 Glass commodities are depyrogenated to provide a _____-log reduction in pyrogens. (Typically 3-log) 3.4.1.3 The tunnel will not experience more than ____% (Typically 90-95%) downtime at production speeds defined in the commodity table below. 3.4.1.4 Commodity Table
Commodity Type
Tubular or Molded
Volume
Weight
Height
Vial OD
Vial ID
Rate (V/Min)
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Comments
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USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
3.4.1.5 Vial Handling: Vials are received from the washer output deadplate and fed onto the tunnel conveyor belt. The vials are then transported through the heat zone, are depyrogenated, cooled down and fed onto the outfeed deadplate. 3.4.1.6 Controls: The depyrogenation tunnel shall be operable by one person, in conjunction with the washer, with safety related faults stopping the tunnel conveyor belt immediately. The tunnel conveyor belt shall not be allowed to restart without operator intervention. The emergency-stop function does not stop the fans or heaters of the tunnel. The tunnel will have a night mode that will allow an energyefficient mode of operation to hold temperature and sterility of the tunnel between batches. 3.4.1.7 Pressure Balance: The differential air pressure in the heat zone must always be positive relative to the cool down zone, infeed zone, and the external room environment. The differential pressure setpoints are: Infeed Zone ________ Pascal (Typ. 2Pa) Heat Zone ________ Pascal (Typ. 4Pa) Cool Down Zone ________ Pascal (Typ. 3Pa) Filling Suite ________ Pascal (Typ. 12-20 Pa) Transition gates are required between the infeed zone and the heat zone, and between the heat zone and the cool down zone. These gates are _________ (fixed, manually adjustable, automatically adjustable) in height. 3.4.1.8 Access Ports: Each zone will have access ports above the HEPA/ULPA filtration to allow for filter integrity testing without disassembly of the equipment. 3.4.1.9 Instrumentation: Industry standard instrumentation and display devices will monitor all process critical parameters. 3.4.2 Infeed Zone Glass enters the tunnel belt and is spread to the width of the tunnel belt.
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USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
3.4.2.1 Temperature: No temperature control is provided in the infeed zone, but a limited amount of heated air from the heat zone passes into the infeed zone. This begins to raise the temperature of the glass prior to entering the heat zone. A temperature measuring transmitter with display, recording and alarming capabilities will monitor temperature. 3.4.2.2 Air Flow: The glass is subjected to unidirectional air flow consistent across the width of the zone. Air velocity is maintained to +/-20% of the average airflow, and is delivered from the HEPA air filter at a rate of ______meters/sec. (Typically 0.5 m/sec.) Fresh air is provided to the inlet of the HEPA filter through a roughing filter. Air is not recirculated. A differential pressure device with display and alarming capabilities will monitor the differential pressure between the internal zone and the outside room pressure. Exhaust air exits the Infeed Zone through a duct to the outside of the washer/tunnel room. 3.4.3 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). The FH calculation must be provided as an appendix at the end of this document. The FH provides the necessary temperature and time to ensure the required ___log endotoxin reduction specified.
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USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
3.4.3.1 Temperature: The temperature within the heat zone must be adjustable in 5C increments from ambient to a maximum of 350C. The temperature uniformity / distribution measured above the conveyor in the empty tunnel should be within the range of +/- _____C (Typically 5C) of the average, as measured in line across the belt. The temperature uniformity / distribution measured inside of the commodity should be within the range of +/- _____C (Typically 5C) for tubing glass, and +/- _____C (Typically 10C) for molded glass as an average, as measured in line across the belt. A temperature measuring transmitter with display, recording and alarming capabilities will control and monitor temperature. 3.4.3.2 Air Flow: The glass is subjected to laminar air flow consistent across the width of the zone. Air velocity is maintained to +/-20% of the average airflow, and is recirculated through the HEPA air filter at a rate of ______meters/sec(Typically 0.5 m/sec.). Fresh air is provided to the inlet side of the HEPA filter through a roughing filter. There is no exhaust in the heat zone. Fresh air is used to make-up air that is lost to the adjacent zones through the gates. A differential pressure device with display and alarming capabilities will monitor the differential pressure between the internal zone and the washer/tunnel room pressure. 3.4.3.3 Room Classification: The air quality in the heat zone is ________. (Typically EU class B) 3.4.4 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, or damage to the outfeed guides due to high temperatures.
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USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
3.4.4.1 Temperature Control: The temperature of the glass must be cooled down to a maximum of ________C at the exit of the tunnel. Cooling of the vials is accomplished using fresh HEPA filtered air. The air can be additionally cooled using cooling coils and chilled water as a media. A temperature measuring device with display, recording and alarming capabilities will monitor temperature. 3.4.4.2 Air Flow The glass is subjected to unidirectional air flow consistent across the width of the zone. Air velocity is maintained to +/-20% of the average airflow and passes through the HEPA air filter at a rate of ______meters/sec. Fresh air is provided to the inlet side of the HEPA filter through a roughing filter. Air is not recirculated, but exhausted out a vent in the top of the tunnel. A differential pressure device with display, recording and alarming capabilities will monitor the differential pressure between the internal zone and the outside room pressure. 3.4.4.3 Room Classification: The air quality in the cool down zone is ________. (Typically EU class B) 3.4.4.4 Cool Down Zone Sterilization: The cool down zone, 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, a minimum cycle of _____ C for at least _____ minutes is required. (Typically 170C for 60 minutes (Compendia for Dry Heat Sterilization)) Air must be circulated throughout the cool down zone for the complete sterilization cycle. For vaporized hydrogen peroxide, the complete cycle must be provided, including the heating, gas, aeration and testing procedures. Heating, recirculation and exhaust of the sterilization cycle must be permanently designed into the system.
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Depyrogenation Tunnel
3.4.5
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
Power failure/Recovery In the event of a power failure, 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. (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). 3.4.6
“Emergency Stop” The system shall have an E-Stop mechanism designed to stop the conveyor belt and gates immediately. The fans and heaters do not stop during Emergency stop. The E-Stop mechanism(s) shall be located in easily accessible areas around the equipment as required by national and local safety standards.
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3.4.7
USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
Alarms and Warnings 3.4.7.1 “Critical alarms” shall take action automatically to shut the equipment down and notify the operator. The operator shall be required to acknowledge the alarm before the alarm can be reset and the system restarted. Once the alarm is reset, the operator may restart the system. 3.4.7.2 “Non-Critical alarms” shall take action to shut the equipment down at the end of the cycle, and notify the operator once stopped. The operator shall be required to acknowledge the alarm before the alarm can be reset and the system restarted. Once the alarm is reset, the operator may restart the system. 3.4.7.3 “Operator Alert” shall notify the operator and take no further action. Non-Critical warnings and will illuminate the alarm indicator but allow the system to continue to operate. The operator shall be required to acknowledge the warning in order to silence the alarm horn, and the alarm indicator shall be extinguished when the warning condition disappears.
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Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1
Depyrogenation Tunnel
Alarm or Informational Message
Critical Alarm
NonCritical Alarm
October 2003
Informational Message
Response Operator Interlock(s) Procedural X
Emergency Stop
X
Control Platform Communication Watchdog
X
X
Control Power Fault
X
X
Heat Zone High Temperature Fault
X
X
XXXX
X
X
YYYY
X
X
ZZZZ
X
Motor Faults
X
X
CONTROL PLATFORM Battery Low Warning
X 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. 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:
User interface access levels
Frequency of data point collection
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USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
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. User ID and password provide security for data and operator access. 3.5.2
User Interface with Supervisors and Operators The control platform 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 are ___________. (English, Spanish, German, French, Etc.)
3.5.2.2 Displayed Requirements: See table in section 3.3. 3.5.3 Interface with Other Equipment The control system shall include the interfaces necessary to facilitate operation and configuration. For example:
A Data Highway Plus communications port shall be provided.
A Modem communications port shall be provided.
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Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1
Depyrogenation Tunnel
3.5.4
October 2003
Security Levels (Modify as required for specific equipment) 3.5.4.1 Supervisory: Data access only, including approvals and transfer of data to hierarchical systems. No operational or maintenance/set-up access allowed. 3.5.4.2 Operator: Operational access only, including start, stop, reset and fault correction. No data transfer allowed. No maintenance or set-up access allowed.
3.5.4.3 Maintenance: Operational access, including start, stop, reset and fault correction. Maintenance and set-up access including change parameters, set-ups and adjustments and diagnostics. No data access or transfer rights. 3.5.5 Data Collection
Critical process parameters are recorded on a permanent chart recorder, and also displayed on the same recorder.
Critical process parameters are processed and available through the control PLC. Data is available to a supervisory system via the data highway connection.
No electronic data storage provided on this control system. The following shall be recorded:
Temperature for each zone
Differential Pressure for each zone
Belt speed
3.6
Environment 3.6.1
Layout Allocated floor space for the equipment is _____ inches by ________ inches with at least a _______inch corridor around the periphery for the equipment.
Vertical clearance is _________ inches.
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Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
See attached drawing #________________________
Layout is specific to the size equipment being used and system requirements of the equipment. 3.6.2
Physical Conditions 3.6.2.1 Room will be non-hazardous 3.6.2.2 Class _________. (Typically EU Class D or C) 3.6.2.3 Biohazard Level __________. (Typically BL-1, BL-2 or BL3) 3.6.2.4 Enclosure Rating __________. (Typically NEMA 12 or IP 54)
3.6.2.5 Cleaning Requirements ________. (hand wash, spray down, automatic) 3.6.3 Sterilization Requirements – Refer to section 3.4.4.4 3.6.4
Intended Operating Environment: The depyrogenation tunnel shall be mounted in a GMP environment with a temperature range of 15 to 25 °C, noncondensing humidity. Vibration levels in operating environment are negligible. The Seismic Zone in the operating environment is zone (1, 2, 3, 4, or 4A).
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USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
4.0 CONSTRAINTS 4.1
Milestones and Timelines Based on the model outlined below, establish the project milestones with a timeline:
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4.2
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USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
October 2003
Equipment Constraints 4.2.1
Environmental Conditions The depyrogenation tunnel is to be used at the following environmental conditions: Altitude ________ ft above sea level
4.2.2
HVAC Equipment Constraints Process air is to be provided at the Infeed, Heating and Cool Down Zones. Indoor Temperature:
C
Exhaust air will exit from the cool down zone at a temperature not to exceed __________C 4.2.3
Equipment Generated Vibration The maximum allowable equipment vibration generated during operation is _________.
4.3
Compatibility and Support 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.
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 vendor 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.
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Depyrogenation Tunnel
4.3.3
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
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. Base Utilities Worksheet Related Discharges
Volume
pH
Temperature
Materials Chilled Water
Volume
pH
Temperature Air Exhaust
Volume
Locations
Temperature
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Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
Contaminants 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 equipments, 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 depyrogenation tunnel is intended to be operated continuously in either production mode or night mode. Operation of the depyrogenation tunnel shall be suspended, and the system shall be available for preventative maintenance or routine service as required.
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 shall meet ASME or 3A specification requirements.
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Depyrogenation Tunnel
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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 Not Applicable
4.5.3
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.
4.5.4
EMI / RFI levels are: The depyrogenation tunnel will be used in an area where twoway radio communication devices are in operation. The depyrogenation tunnel shall meet CE requirements for electrical noise immunity and emissions.
4.5.5
Containment Not Applicable
4.5.6
Labeling All equipment and control wiring shall be labeled and identified. Tag numbering shall be consistent between the devices and all corresponding documentation.
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
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Depyrogenation Tunnel
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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. Accessibility for operation and maintenance personnel. 6. Ability to remove and replace the conveyor belt within _______ minutes without moving adjacent equipment.
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. The Supplier shall provide a Project Manager for the project to provide a single communication point with the User. The project shall utilize the GAMP methodology when developing the system and documentation.
5.2
Testing Describe the Supplier testing requirements. Reference the Validation Test Plan, Factory Acceptance Test, special tests, etc. This section should also include required amount of demonstrated run time, any special materials necessary to complete testing, integration testing, etc. In order to verify system performance, the User shall witness the execution of the Factory Acceptance Test procedures. The Supplier shall notify the User _______ weeks in advance of the start of this test. The Factory Acceptance Test Specification shall be submitted to the User for review and approval prior to execution. A minimum of _______ weeks shall be allowed for the User to review and to comment and/or approve the Factory Acceptance Test Specification. Refer to the Equipment Validation Plan for applicable procedures.
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Depyrogenation Tunnel
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5.3 Delivery The depyrogenation tunnel, 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 “asbuilt” condition with final delivery. All final documents shall be shipped with transmittals that identify them as contractually required documents. All final documents and drawings shall reflect “as-built” condition. All documents shall in the language of the destination country and supplied with hard copies and electronic versions supplied in the format identified for each document:
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)
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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)
Component Cut Sheets
Microsoft Word XX (*.doc) or Excel XX (*.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. 5.4.1 5.4.2
Start-up Support (list available options) 5.4.1.1 Training (list training options available) Post Start-up Support (list post-startup support available) 5.4.2.1
Technical Support Telephone (Voice or Modem) Replacement Parts Availability List (Normal lead times shall be listed)
5.4.2.2
User Site Support Preventative Maintenance (list maintenance contracts available) System Improvements (supplier shall notify user of any improvements available on a regular basis)
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Page 29 of 32 USER REQUIREMENTS SPECIFICATION
JETT
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1
Depyrogenation Tunnel
October 2003
6.0 GLOSSARY If necessary, attach a glossary, which includes definitions of terms that may be unfamiliar to the Supplier or terminology that may have meanings specific to entries on this User Requirements Check sheet. For example (example list is not intended to be complete): Acronym
Definition
C BL CE CFR cGMP dB E-stop EMI FH ft GAMP GUI HEPA HMI HVAC ISA ISO JETT LEL NEMA OIP Pa
Degrees Celsius Biohazard Level Common European Standards Code of Federal Regulations current Good Manufacturing Practices Decibels Emergency Stop button Electro-Magnetic Interference Thermal Activation Factor Feet Good Automation Manufacturing Practices Graphic User Interface High Efficiency Particulate Air filter Human – Machine Interface Heating, Ventilation, and Air Conditioning Instrument Society of America International Organization for Standardization Joint Equipment Transition Team Lower Explosion Limit National Electrical Manufacturers Association Operator Interface Panel Pascal
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Page 30 of 32
JETT
USER REQUIREMENTS SPECIFICATION
Depyrogenation Tunnel
Acronym PLC PSIG RFI S88 URS ULPA VAC
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
Definition Programmable Logic Controller Pounds/Square Inch Gage Radio Frequency Interference Batch Operations Standards User Requirement Specification Ultra Low Penetration Air filter Volts Alternating Current
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Page 31 of 32 USER REQUIREMENTS SPECIFICATION
JETT
Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
7.0 REFERENCES List references that were used in preparing this document or that provide additional details, 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
Page 32 of 32 USER REQUIREMENTS SPECIFICATION
JETT
Depyrogenation Tunnel
Doc ID: DT001urs_A Depyrogenation Tunnel Rev. 1 October 2003
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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