U
SER
R
EQUIREMENTS
T
EMPLATE
NOTES for use of the User Requirements Template:
Upon completion of the template, delete this page prior to updating the Table of Contents and printing.
1. Many areas of this template have selections or tables that have been prepared for guidance and ease of template completion. Text in italics is intended to be used as notes to the User and should be deleted prior to printing. Any options and/or examples that are not applicable to the specific document being created should be deleted as well.
2. To update the final Table of Contents, place the cursor inside the shaded area, press the Right mouse key, and select Update Field.
3. Items that can be directly tested are identified with a
.4. Where possible, the User should identify the source (e.g. studies, standards, etc.) for the acceptable ranges of variables or other critical requirements that have been derived.
REVISION HISTORY
Rev. Date Approval Revision SummaryA1 12/10/01 A2 05/17/01 A3 05/18/01 A4 10/18/01 A5 11/12/01 A6 11/19/01 A7 12/05/01
A8 02/20/02 Content review by Mike Casey, Ramon LeDoux, Dale
Noteboom and Marieva Rivera C1 05/20/02 M. Rivera Format Review
C2 7/12/02 M. Casey Validation Review
0 8/19/02 D.
Noteboom
T
ABLE
OF
C
ONTENTS
1.0 INTRODUCTION...5 2.0 OVERVIEW...6 3.0 OPERATIONAL REQUIREMENTS...7 3.1 CAPACITY...7 3.2 PROCESS REQUIREMENTS...7 3.3 PROCESS CONTROL...8 3.4 FUNCTIONS...83.5 DATAAND SECURITY...12
3.6 ENVIRONMENT...14
4.0 CONSTRAINTS...17
4.1 MILESTONESAND TIMELINES...17
4.2 EQUIPMENT CONSTRAINTS...18
4.3 COMPATIBILITYAND SUPPORT...18
4.4 AVAILABILITY...21 4.5 PROCEDURAL CONSTRAINTS...21 4.6 MAINTENANCE...22 5.0 LIFE-CYCLE...23 5.1 DEVELOPMENT...23 5.2 TESTING...23 5.3 DELIVERY...24 5.4 SUPPORT...25 6.0 GLOSSARY...26 7.0 REFERENCES...27 8.0 APPROVAL...28
Project No.:
Insert the unique project number associated with this particular URS.
Document No.:
Insert the Document Identification Number and Revision.
Document Description:
Insert description of document, e.g. Saturated Steam Autoclave for Sterile Manufacturing Support.
1.0INTRODUCTION
Note: Insert your own description and introduction. You may wish to include your own requirements and specifics to allow the inexperienced reader,
contractors, and suppliers adequate explanation to understand the scope of the equipment.
Describe who produced the document, under what authority, and for what purpose.
Describe the contractual status of the document. Include or reference as an attachment the “legal” paragraph that communicates purchasing terms and conditions in this section.
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.
Refer to the Equipment Validation Plan that outlines the Supplier’s responsibilities is attached.
Remove any options that are not applicable for this project, if other uses will apply list each separately.
This is to be utilized as a guide for the user to answer the majority of questions involved in specifying the “what” for the equipment. Addendums may be used to round out the requirements.
2.0OVERVIEW
This document encompasses the normal range of equipment operations. This section should be expanded to provide a high level description of the system explaining why it is required and what is required of it. Include the background, key objectives, and the main functions and interfaces. Obviously, technology improvements and new applications may require deviation from this template.
The User should consider including information on the following:
Use: Describe what applications the equipment/system will be used to support. Include a brief explanation of the general functions.
For example: The autoclave will use saturated steam to sterilize product contact and critical equipment used in the aseptic formulation and filling of parenteral drugs. Capacity and/or Critical Attributes: Provide a brief description of the equipment/system capacity or throughput
requirements or the critical attributes that make it desirable to acquire the system. (Also reference any industry standards for the autoclave that are applicable.)
For example: Provide actual chamber size needed or number of specific components to properly size the chamber.
For example: The system must provide, at minimum, the following basic cycles:
:
Vented Saturated Steam Cycle 1) Heating Phase
2) Exposure Phase 3) Cooling Phase Forced Air Removal Cycle
1) Air Removal Phase 2) Heating Phase 3) Exposure Phase 4) Exhaust Phase
5) Vacuum Drying Phase 6) Vacuum Relief Phase
3.0OPERATIONAL REQUIREMENTS
3.1 Capacity
Describe the range or list specifically the materials, products or equipment to be sterilized.
- Materials - Products
- Liquids – Vented or Non-Vented
Size of loads.
For example for materials: lab glassware, plastic tubing, liquids in sealed glass containers, and liquids in sealed plastic containers.
3.2 Process Requirements
Describe the number of doors and loading and unloading requirements for the autoclave. Define if the equipment will be floor or pit mounted and how this will impact the loading requirements.
Describe in detail the requirements for the various steps/phases that are required. In each phase identify the critical control requirements and variables that are needed. For example:
Air Removal Phase (if required) - Range of vacuum (or gravity only) - Number of vacuum pulses.
- Time to attain vacuum - Range of vacuum hold time. - Vacuum level
For the following phases also provide critical control requirements and variables:
Charge Phase
Exposure Phase
Exhaust Phase
Drying Phase (if required)
Define door seal medium (e.g. clean steam or pharmaceutical air) requirements. Define if backup door sealing is required.
3.3 Ancillary Equipment
Describe ancillary supplied equipment; for example, loading carts/transfer carriage requirements.
3.4 Process Control
Identify the critical process measurements such as temperature and pressure. For each critical measurement or control device list the:
Measurement Range
Setpoint Range
Parameter Control Tolerance
If you desire special monitoring such as monitoring at specific locations in the chamber or piping or redundant process
measurements include it in this list (for example include chamber drain, chamber load probe (and number of probes required), chart recorder probe). If there are standardized tests you want the supplier to run that have given tolerances (e.g. European Norm 285) list the applicable tests. If you are unsure what the supplier provides in their standard models, have them provide that information to you in their request for submittal.
Note: At a minimum, list the critical, process parameters. Consider documenting how/where each of the parameter requirements was determined.
3.5 Functions
3.5.1 Operation
Enter your specific operational requirements here.
Basic configurable cycles or phases required.
Recipe capabilities. (Linking of cycles or phases
sequentially) Consider providing a recipe that the system
must be capable of running.
Operator interaction with the system. Describe your
expectations for keyboard, mouse or touch screen interaction. The following are examples: The system shall be able to run the multiphase cycle from start to finish with no operator interaction required after the cycle is properly initiated.
The system shall be operated locally at the autoclave.
Describe the control system requirements in terms of manual, semi-automatic and automatic operation. Be as specific as possible on “what” the system should do.
3.5.2 Power failure/Recovery
Power Failure: Insert your specific power failure/recovery scheme here.
For example:
In the event of a power failure, the system shall protect in the following priority:
Personnel
Equipment
Product
In the event of a power failure the autoclave controls shall mechanically fail to a state that places the chamber in a vented state at atmospheric pressure.
Recovery Methods: Insert your specific power failure recovery scheme here.
For example:
Manually re-start based on operator inputs (Operator initiates power recovery sequence).
Re-start based on last state before loss of power. (System runs through power recovery sequence when operator start signal is given)
If there is an automatic batch reporting system, the
information shall be retained in the event of a power failure (A UPS is required for automatic batch reporting systems for data retention).
Abort or resume cycle based on length of power failure or temperature deviation from setpoint.
3.5.3 “Emergency Stop”
Insert your specific “Emergency Stop” (E-Stop) strategy and communication scheme here.
For example: The system shall have an E-Stop mechanism designed to stop all physical movement of the equipment
immediately. The E-Stop mechanism(s) shall be located in close proximity to the autoclave loading and unloading doors.
3.5.4 “Operator Abort”
Describe the requirements for the system response to an operator initiated cycle abort. Describe the final state the autoclave needs to be in at the conclusion of the abort sequence.
3.5.5 Alarms and Warnings
“Critical alarms” - Insert your specific “Critical Alarm” action
scheme here.
For example: Critical Alarms shall take action automatically to shut the equipment down and notify the operator of the
condition(s). The operator shall be required to acknowledge the alarm before the alarm can be reset and the system restarted. Once the alarm is reset, the operator may restart the system.
Note: For a customized equipment application, include an alarm table, like the example that follows.
The Equipment shall have the following critical alarms and warnings:
Alarm or Warning Critical Informational
Emergency Stop X
Control Platform Communication Watchdog X
Control Power Fault X
Main Instrument Air Fault X
Low Steam Supply Pressure X
Chamber Temperature Deviation X
Jacket Temperature Deviation X
Vacuum System Performance Failure X
Motor Faults X
CONTROL PLATFORM Battery Low Warning X
The list of critical alarms in the table is not intended to be a comprehensive list of all alarms for the system. A complete alarm list will be developed and included in the Functional Specification document.
For a standard equipment type application, request the supplier to submit the complete alarm list and differentiate between critical and informational alarms.
Note: Consider documenting how “critical and non-critical” criteria were determined.
3.5.6 Informational Messages
“Informational Messages” shall notify the operator and take no further action.
Define the interlocks that are to be supplied with the system. For example:
The cycle cannot be initiated until the jacket temperature is above 100C.
The cycle cannot be initiated until the door(s) is closed and locked.
The cycle cannot be initiated unless adequate steam, air and water pressure are available.
There are no active alarms.
3.6 Data and Security
Controls provided with Electronic Data Collection intended for use in the manufacture of pharmaceutical products shall be required to comply with 21 CFR Part 11 . The supplier shall stipulate the methods by which this criterion is met. It is helpful to be specific here.
Security for data and operator access is provided by (User ID/Password, Card Reader, Biometric (Fingerprint, eye scan, voice recognition, etc.), etc.).
3.6.1 User Interfaces
This section should address the following issue:
Operator interface access levels
Access to all Input/Output values and system status bits shall be provided through a data-communication link.
3.6.2 User Interface with Supervisors and Operators Insert your interface scheme here. For example:
The CONTROL PLATFORM system shall include interfaces with the Operator and Supervisor that ensures easy, safe, and reliable operation.
An operator-interface panel shall be provided and mounted near the equipment or on the equipment. This panel shall provide the necessary switches, indicators, and devices to operate the
3.6.2.1 Language requirements
Specify language in which information will be displayed (i.e. English, Spanish, German, Bilingual, etc.)
3.6.2.2 Displayed Requirements:
State the system of measurement that will be used (English or Metric (S.I.)).
Parameter Format Unit(s) of measurement
XXXXXXX (###.#) units
YYYYYYY (##) %
3.6.3 Security Levels
List the total number of different access levels that will be required. Provide a general description of the access rights for each level (screen navigation, operational control, control loop variable manipulation, alarm setpoint manipulation, etc.). 3.6.4 Interface with Other Equipment
The control system shall include the interfaces necessary to facilitate operation and configuration. For example :
An RS-232 communications port shall be provided.
A Modem communications port shall be provided.
A high-speed configuration/monitoring connection shall be provided.
3.6.5 Data Collection
Consider any archiving and reporting requirements here.
None
Recorder
Process Printout
Define the list of process variables to be recorded and frequency of recording. For example:
Chamber Temperature
Chamber Pressure
Jacket Temperature
Run Time
If the system provides a report, define the expectations for information to be included in the report
Recipe ID
Critical Recipe Parameters Batch Number
Operator ID
Date / Time of cycle start Alarms
Sterilizer ID#
Time, Pressure, and Temperature at: End of each vacuum
End of each pressure pulse Start of plateau period End of plateau period Start of drying period End of drying period
3.7 Environment
Provide details of the physical environment in which the
[equipment/system] will be operated. Also note the maximum height, width and depth that the equipment can be to fit through doorways from the point where the equipment enters the building to the point of
installation. 3.7.1 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.
See attached drawing #________________________ (if applicable).
Floor or pit mounted
Cabinet mounted
Recessed in 1 or 2 walls
Door type: hinged, vertical or horizontal sliding
Bio-seal requirements
Layout is specific to the size equipment being used and system requirements of the equipment.
Maximum allowable: Height Length Depth Weight Floor Load 3.7.2 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
Number of air changes Particle Ingress
Biohazard Level
List the critical biohazard level requirements for the environment. BL-1 BL-2 BL-3 BL-4 Rating of enclosures
List the rating requirements for enclosures in the environment. NEMA 1 (Open)
NEMA 12 (Oil tight) NEMA (Wash down)
NEMA 4X (Washdown and non-Corrosive) 3.7.3 Cleaning Requirements
Hand-Wash
Auto-Wash
Sanitization
Steam Clean
3.7.4 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
4.0CONSTRAINTS
4.1 Milestones and Timelines
Use one of the two schedule outlines provided below. Delete the schedule not selected for use. Fill in time scales or dates as appropriate and
add/delete items as applicable. If available, refer to the user’s project schedule to assist with this area. An agreed upon timeline may be referenced here and attached as an appendix.
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 Equipment Generated Vibration
The maximum allowable equipment vibration generated during operation is <value>.
4.3 Compatibility and Support
Include any requirements for compatibility with other User systems. In the examples provided below, fill in blanks with the appropriate
information. Delete areas that are not applicable to this application. 4.3.1 CONTROL PLATFORM Controllers
The Supplier shall utilize Control Platform Controllers that shall include a communications port. The Supplier shall provide documentation that the program (embedded software) was developed and coded utilizing
program development and documentation software. The supplier shall indicate the use of custom or “bespoke” code within the equipment, and shall supply licensing of the custom code for the life of the equipment.
An escrow agreement shall be required in the event the supplier cannot support the supplied custom software any longer. In such instances, the source code and all information regarding the source code shall be given to the user in a timely fashion to prevent downtime of the equipment.
4.3.2 Preferred Vendor List
If necessary the user may attach a Preferred Manufacturers List of critical components. Refrain from driving the supplier into
customizing their equipment for your company. If the supplier wishes to deviate from the Preferred Manufacturers List, a listing of the proposed components and instrumentation manufacturers indicating type and model numbers shall be submitted with the quotation, along with an explanation of why the deviation is recommended.
4.3.3 Utilities
The utilities and space involved needs to be discussed prior to purchasing the equipment. Obviously, the actual equipment size is but a small part of the entire scope of work necessary to implement a larger system. The unit and its support equipment must be able to be installed in current building facilities.
The User shall ensure that the following utilities are available and that the utility supply lines and piping are terminated with fittings or connections, which are compatible with those described on the Customer Connection Drawings.
The Supplier shall specify utility data, which is marked with a triangle or code of some type (number code). Utility data, which are not specified or marked with a triangle or code, 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
User should indicate the maximum or minimum volume, pH, temperature, etc. of discharges
Electricity Phases
Amperage
Uninterruptible Power Supply (Define Use)
Control Air Pressure For example:
_______ PSIG (must be clean, dry ISA instrument quality air, capacity to be determined by size of equipment). Recommend at least 90 PSIG constant air pressure for all equipment, unless specified.
Clean/Pure Steam (also must specify if pure or clean steam is to be used. Further, detail if plant steam to be used in jacket and then add plant steam requirements if appropriate. Pressure in chamber For example:
_______ PSIG
_______ Volume (peak and average)
Pressure in jacket For example: _______ PSIG
_______ Volume (peak and average)
Other Utility RequirementsProvide details regarding any other utility systems that are required to support operation of the equipment/system (e.g
4.4 Availability
The [equipment/system] is intended to be operated <Continuously, Regularly, __ hours per day, __ hours per week>.
Operation of the [equipment/system] shall be suspended, and the system shall be available for preventative maintenance or routine service <__
hours per week, __ continuous hours per week, __ days per month, __ weeks per year>.
4.5 Procedural Constraints
4.5.1 Autoclave Interior Finish
Describe any local procedural requirements such as local standards, which must be adhered to if applicable.
Describe materials of construction and requirements for material certification.
List critical requirements for surface finish, roughness, etc. Other standards are attached. The Supplier shall adhere to the indicated sections only.
4.5.2 Autoclave Exterior Finish
Describe external sheet metal materials and finishes of the autoclave. This is especially critical for the side that would interface to an aseptic area.
4.5.3 Critical Piping Finishes
All piping welds for clean steam, pharmaceutical air, sanitary chamber drain and sterile vent system shall be manufacture to standards (e.g. AISI, ASTM or ASME).. Piping shall be (316L Stainless Steel, 316 Stainless Steel, 304 Stainless Steel, etc.) List critical requirements for surface finish, roughness, etc. Typically 25-35 micro-inch RA is acceptable for steam and air. Other standards are attached. The Supplier shall adhere to the indicated sections only.
4.5.4 Noise Level Constraints
Insert your own noise level constraint requirements here.
For example: The noise level generated during operation of the [equipment/system] will not exceed 85 DB from 3 feet away. 4.5.5 EMI / RFI levels are:
Insert your own electrical and radio noise immunity requirements here.
For example:
The [equipment/system] [will/will not] be used in an area where two-way radio communication devices are in operation. The [equipment/system] shall meet CE
requirements for electrical noise immunity and emissions. 4.5.6 Labeling
All equipment, components, and control wiring shall be labeled and identified.
4.6 Maintenance
Describe the expected hardware and software maintenance support including: ease of maintenance, expansion capability (software only), likely enhancements (software only), expected lifetime and long-term support.
Include the necessary wiring or other installation requirements to support periodic calibration and preventative maintenance.
System shall be maintained on a schedule as indicated by the supplier. Supplier is to provide (at minimum) the following maintenance
instructions:
1. All sub-systems provided (Maintenance and operation manuals of vendor equipment)
2. A comprehensive lubrication list and recommended lubrication schedule
3. A comprehensive recommended maintenance (regular
recommended inspection intervals, wear points, recommended spare parts list)
4. Supplier shall supply ______ Copies of Operation, Installation, Maintenance and de-commissioning manuals
5.0LIFE-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.
5.3 Delivery
The [equipment/system], with all options, equipment, and the
documentation listed below, shall be delivered to the User’s receiving dock.
5.3.1 Documentation
Installation, operation, and maintenance instruction documentation for the system shall be developed to a level that is comprehensible to a high school graduate.
The Supplier shall use the formats described in the GAMP
Supplier Guide, Current Version, to produce the documentation.
The Supplier shall provide the documentation for preliminary review. The Supplier shall provide documentation reflecting “as-built” condition with final delivery.
All final documents shall be shipped with transmittals that identify them as contractually required documents. All final documents and drawings shall reflect “as-built” condition.
All documents shall in the language of the destination country and supplied with hard copies and electronic versions supplied in the format identified for each document:
User should define format for document transmission (ie. MS Word, Autocad, etc.) Below is an example:
Project Plan Microsoft Word 97 (*.doc)
User Requirements Specification Microsoft Word 97 (*.doc)
Functional Specification/Requirements Microsoft Word 97 (*.doc)
Design Specifications Microsoft Word 97 (*.doc)
Controls Test Microsoft Word 97 (*.doc)
Hardware Installation Test Microsoft Word 97 (*.doc)
Operational Test Microsoft Word 97 (*.doc)
Factory Acceptance Test Microsoft Word 97 (*.doc)
Process and Instrumentation Diagram (P&ID) AutoCAD version 12.0 (*.dxf)
Instrument Listing Microsoft Word 97 (*.doc) or Excel 97 (*.xls)
Control Schematics AutoCAD version 12.0 (*.dxf)
Control Panel Assembly Drawings AutoCAD version 12.0 (*.dxf)
Equipment Assembly Drawings AutoCAD version 12.0 (*.dxf)
Bill of Materials Microsoft Word 97 (*.doc) or Excel 97 (*.xls)
Spare Parts List Microsoft Word 97 (*.doc) or Excel 97 (*.xls)
Component Cut Sheets Microsoft Word 97 (*.doc) or Excel 97 (*.xls)
CONTROL PLATFORM Program
Printout and Disk File XXX Program Development format
OIP Configuration Printout and Disk File XXX Program Development format
Certificates of compliance for materials, welding, surface finish inspection.
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
System Improvements (supplier shall notify user of any improvements available on a regular basis)
6.0GLOSSARY
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 Degrees Celsius
BL Biohazard Level
CFR Code of Federal Regulations
DB Decibels
EMI Electro-Magnetic Interference
Ft Feet
GUI Graphic User Interface HMI Human – Machine Interface
HVAC Heating, Ventilation, and Air Conditioning ISO International Organization for Standardization JETT Joint Equipment Transition Team
LEL Lower Explosion Limit
OIP Operator Interface Panel RFI Radio Frequency Interference URS User Requirement Specification Pure Steam Non-condensed WFI
Clean Steam Steam produced from deionized water Plant Steam Steam used in general plant applications.
Typically contains additives designed to facilitate condensate collection and reuse.
7.0REFERENCES
List references that were used in preparing this document or that provide additional details, such as:
o Equipment Validation Plan
o Current revision of GAMP Guidelines o Vendor Piping Certification (if applicable) o Customer Connection Diagram
o Approved Instrumentation List o Process Flow Diagram
o 21 CFR Part 11
o National Electric Code o S88
8.0APPROVAL
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.
