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USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
Page 1 of 30
Doc ID:
BIOREACTOR URS A1
April 2005
JETT
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
Page 2 of 30
Doc ID:
BIOREACTOR URS A1
April 2005
REVISION HISTORY
Rev.
A1
Note:
Date
4/5/2005
Developed By:
JEG
Revision Summary
For an initial release, provide a note that the document is being routed for initial
review/approval.
JETT
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
Page 3 of 30
Doc ID:
BIOREACTOR URS A1
April 2005
TABLE OF CONTENTS
1.0
INTRODUCTION (SCOPE)............................................................................................4
2.0
OVERVIEW.......................................................................................................................5
3.0
OPERATIONAL REQUIREMENTS..............................................................................5
3.1
CAPACITY........................................................................................................................5
3.2
PROCESS REQUIREMENTS..............................................................................................6
3.3
PROCESS CONTROL........................................................................................................6
3.4
FUNCTIONS......................................................................................................................8
3.5
DATA AND SECURITY....................................................................................................14
3.6
ENVIRONMENT..............................................................................................................17
4.0
CONSTRAINTS..............................................................................................................18
4.1
MILESTONES AND TIMELINES......................................................................................18
4.2
EQUIPMENT CONSTRAINTS..........................................................................................20
4.3
COMPATIBILITY AND SUPPORT....................................................................................20
4.4
AVAILABILITY...............................................................................................................22
4.5
PROCEDURAL CONSTRAINTS........................................................................................22
4.6
MAINTENANCE..............................................................................................................23
5.0
LIFE-CYCLE...................................................................................................................24
5.1
DEVELOPMENT..............................................................................................................24
5.2
TESTING.........................................................................................................................24
5.3
DELIVERY......................................................................................................................24
5.4
SUPPORT........................................................................................................................26
6.0
GLOSSARY.....................................................................................................................27
7.0
REFERENCES................................................................................................................28
8.0
APPROVAL......................................................................................................................29
9.0
ATTACHMENTS.............................................................................................................30
JETT
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
Page 4 of 30
Doc ID:
BIOREACTOR URS A1
April 2005
Project No.:
Insert the unique project number associated with this particular URS.
Document No.:
Insert the Document Identification Number and Revision.
Document Description:
BIOREACTOR SYSTEM, JETT Example Blank User Requirements Specification Template Rev.
3.
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
Page 5 of 30
Doc ID:
BIOREACTOR URS A1
April 2005
2.0 OVERVIEW
This document encompasses the normal range of the Bioreactor System and ancillary
equipment operations.
2.1
2.1.2
Cells are transferred into the media filled batch reactor via air pressure and
are then cultured in the bioreactor system under closed conditions. The
inoculum for this reactor is grown in the bioreactor and is pneumatically
transferred into the downstream process. Media can be supplied to this
reactor from any of the Media Preparation Vessels through a series of
transfer panels. Caustic, Antifoam, and nutrients are supplied from
Portable Vessels, using either peristaltic pumps or air pressure to
accomplish the transfer.
The mass spectrometer analyzes the bioreactor sparge, overlay, and vent
gases. Samples of the bioreactor culture are analyzed in the Quality lab
for cell density, pH, and viability. The sterility lab is used to test the
sterility of the culture.
2.1.3
2.2
Capacity
3.1.1 Range of products
3.1.2 Commodities to be used (i.e. vials, bottles, tablets, etc.)
3.1.3 Processed Materials to be used or involved
3.1.4 Production rates
JETT
3.2
3.3
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BIOREACTOR URS A1
April 2005
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
Process Requirements
3.2.1
3.2.2
Process Control
3.3.1
Measurement Range
Temperature
Vessel
Temperature
Jacket
0 to 150.0 C
0.25 C
Agitator Speed
Agitator Drive
0 to 80.0 rpm
1 %FS
Pressure
Vessel
0 to 50.0 psig
0.2 psig
pH_1
Vessel
2 to 13.0 pH
1 %FS
pH_2
Vessel
2 to 13.0 pH
1 %FS
DO_1
Vessel
0 to 200.0 %sat
1 %FS
DO_2
Vessel
0 to 200.0 %sat
1 %FS
CD_1
Vessel
0 to 15 million cells/ml
5 %FS
CD_2
Vessel
0 to 15 million cells/ml
5 %FS
Overlay Air
0 to 500 slpm
1 %FS
O2-Flow
0 to 50.0 slpm
1 %FS
Sparge Air
0 to 50.0 slpm
1 %FS
CO2-Flow
0 to 100.0 slpm
1 %FS
Media Feed
0 to 5.0 kg / minute
1 %FS
Temperature
Inoculum Trap
0 to 150.0 C
0.3 C
Temperature
Retentate Trap
0 to 150.0 C
0.3 C
Temperature
Sample Trap
0 to 150.0 C
0.3 C
Temperature
Bioreactor Seal
0 to 150.0 C
0.3 C
Temperature
Permeate 1 Trap
0 to 150.0 C
0.3 C
Temperature
Permeate 2 Trap
0 to 150.0 C
0.3 C
Temperature
Cell Free LP
0 to 150.0 C
0.3 C
Temperature
Whole Cell LP
0 to 150.0 C
0.3 C
Measurable Variable
3.3.2
Measurement Location
Accuracy
0.25 C
Setpoint Range
Setpoint
Temperature
Temperature
Agitator Speed
Pressure
Measurement
Location
Vessel
Jacket
Agitator Drive
Vessel
Minimum
Maximum
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Doc ID:
BIOREACTOR URS A1
April 2005
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
Setpoint
pH_1
pH_2
Overlay Air
O2-Flow
Sparge Air
CO2-Flow
Media Mass Flow
Temperature
Temperature
Temperature
Temperature
Temperature
Temperature
Temperature
Temperature
3.3.3
Measurement
Location
Vessel
Vessel
Minimum
Maximum
Parameter
Temperature
Temperature
Agitator Speed
Pressure
pH_1
pH_2
Overlay Air
O2-Flow
Sparge Air
CO2-Flow
Media Mass Flow
Temperature
Temperature
Temperature
Temperature
Temperature
Temperature
Temperature
Temperature
Measurement Location
Vessel
Jacket
Agitator Drive
Vessel
Vessel
Vessel
Air inlet group
Air inlet group
Air inlet group
Air inlet group
Media Feed
Inoculum Trap
Retentate Trap
Sample Trap
Bioreactor Seal
Permeate 1 Trap
Permeate 2 Trap
Cell Free LP
Whole Cell LP
Control Tolerance
+ 0.5 oC
+ 0.5 oC
+ 10 RPM
+ 2 psi
+ 0.1
+ 0.1
+ 0.1
+ 0.1
+ 0.1
+ 0.1
+ 0.1
+ 0.5 oC
+ 0.5 oC
+ 0.5 oC
+ 0.5 oC
+ 0.5 oC
+ 0.5 oC
+ 0.5 oC
+ 0.5 oC
USER REQUIREMENTS
SPECIFICATION
JETT
3.4
BIOREACTOR
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BIOREACTOR URS A1
April 2005
Functions
3.4.1
Operation
3.4.1.1 The system shall operate with a minimum of operator involvement.
Operation shall be safe from an operator and environmental
standpoint.
3.4.1.2 The system shall be operated locally at the equipment itself by
means of the operator interface terminal (OIT).
Control Loops
3.4.2.1 Media Initial Charge, Batch Feeds
The system can be fed by a pump at a flow rate range of 0 to 2
lpm. The system can be fed by a means of a pressurized portable
transfer vessel. Tote and container feeds to the system are
measurable and controllable by means of weight using load cells
with a tolerance of + 2 kg.
3.4.2.2 Temperature Control
The process temperature is measurable and controllable to a range
of 25.0 oC to 42.0 oC + 0.5 oC for a period of 8 hours. The unit able
to cool down to less than 8.0 oC
3.4.2.3 Agitator Speed Control
The agitation speed is measurable and controllable to a range of 10
RPM to 200 RPM + 10 RPM.
3.4.2.4 Dissolved Oxygen Control
The dissolved oxygen of the system is measurable.
3.4.2.5 pH Control
The pH of the system content is measurable and controllable to a
setpoint + 0.1.
3.4.2.6 Retentate Recirculation Pump Speed Control
The Retentate Recirculation Pump Speed is measurable and
controllable, flow rate range of 0 to 2 lpm.
JETT
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
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BIOREACTOR URS A1
April 2005
JETT
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April 2005
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
3.4.2.12 Sequence of Operation
CIP Vessel
SIP Vessel
Inoculate Bioreactor
Sample Vessel
Harvest Transfer
Discard to BW
WFI Flush
WFI Flush
Thermal Inactivation
Thermal Inactivation
CIP Vessel
CIP Vessel
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
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3.4.3.2
3.4.3.1.1
Personnel
3.4.3.1.2
Equipment
3.4.3.1.3
Product
3.4.3.2.2
3.4.3.2.3
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April 2005
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
Critical
Alarm
Stackpole
Light
Illuminatio
n
(color/flash
ing)
Information
al Message
Emergency Stop
Control Platform
Communication Watchdog
Alarm or Informational
Message
Response
Interlock
(s)
Operator
Procedural
High Temperature
Low Temperature
Deviation Temperature
High DO
Low DO
Deviation DO
High pH
Low pH
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USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
Alarm or Informational
Message
Critical
Alarm
Deviation pH
Stackpole
Light
Illuminatio
n
Information
al Message
Response
Interlock
Operator
(s)
Procedural
Motor Faults
CONTROL PLATFORM
Battery Low Warning
X
X
USER REQUIREMENTS
SPECIFICATION
JETT
3.5
BIOREACTOR
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April 2005
Safety
The following safety requirements will be incorporated into the system
design and implementation:
1. Input fault alarms generated on over/under current signals on all
analog I/O devices.
2. Failsafe software configuration to match system component fail
positions. System reverts to failsafe positions on power loss.
3. Power-up logic to restore devices to power-up position (note not
necessarily failsafe positions).
4. All OIT enclosures must meet NEMA 4X requirements.
3.5.2
Security
The following security will be required at a minimum on systems:
1. PLC cabinets will be locked and access will be restricted to authorized
personnel.
2. PLC and SLC processors will require keys to switch processor modes.
3. OIT, Workstation, and Server access will be password protected.
4. OIT and Workstation will have automatic-logoff functions based on
inactivity.
3.5.3 User Interfaces
This section should address the following issues:
3.5.3.1
3.5.3.2
3.5.3.3
3.5.3.4
3.5.3.5
3.5.3.6
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April 2005
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
3.5.4
1.2
Displayed Requirements:
State the system of measurement that will be used (English or
Metric (S.I.)).
Temperature
(###.#) units
Unit(s) of
measurement
units
YYYYYYY
(##)%
Parameter
Format
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
None
Recorder
Process Printout
Electronic process printout, Historical Trending
Electronic process printout, Historical Trending and interface to
company network
The following shall be recorded:
3.5.8.6
3.5.8.7
3.5.8.8
3.5.8.9
3.5.8.10
3.5.8.11
3.5.8.12
Temperature
Agitator Speed
Dissolved Oxygen
pH
Air Flow
Carbon Dioxide Flow
Oxygen Flow
Acknowledge Alarms
Enable/Disable Alarms
Access Level
None Operator
Supervisor
Engineer / Maint.
Administrator
Screen Navigation
BIOREACTOR
JETT
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BIOREACTOR URS A1
April 2005
USER REQUIREMENTS
SPECIFICATION
X
X
X
X
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
3.5.8.13
3.5.8.14
3.5.8.15
3.5.8.16
3.5.8.17
3.6
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April 2005
Nitrogen Flow
CIP Flow
CIP Pressure
SIP Temperature
SIP Time
Environment
Provide details of the physical environment in which the Bioreactor will be
operated.
3.6.1 Layout
For example:
3.6.1.1
3.6.2.2
Environmental Classification
List the critical air quality requirements for the environment.
3.6.2.2.1
3.6.2.2.2
3.6.2.2.3
Directional airflow
3.6.2.2.4
Airflow velocity
3.6.2.2.5
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
3.6.2.3
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3.6.2.2.6
Particle Ingress
Biohazard Level
List the critical biohazard level requirements for the environment.
3.6.2.4
3.6.2.3.1
BL-1
3.6.2.3.2
BL-2
Rating of enclosures
List the rating requirements for enclosures in the environment.
3.6.2.4.1
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April 2005
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
4.0 CONSTRAINTS
4.1
USER/(CONSULTANT if applicable)
Master Validation Plan
Equipment Validation Plan/
Risk Assessment
Explanation to Supplier
User Requirements
Specification
(Living Document)
Proposal Analysis
User Audit
P.O.
RFQ
al
pos
Pro
P.O.
Functional
Specification
(traceable to URS)
Approval
Detailed Design
Documentation
(traceable to Functional Specification)
Review System
Acceptance Test Specifications
Integrate with Validation
Documentation as appropriate
Approval
Approva
l
Software
System Acceptance
Testing and Results
User Witness Optional
Maintenance & Support
Documentation
JETT
4.2
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April 2005
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
Equipment Constraints
Describe the operating constraints that the Bioreactor will be required to meet.
For example:
4.2.1 Environmental Conditions
The Bioreactor is to be used at the following environmental conditions:
4.2.1.1 Altitude ________ ft above sea level
4.2.2 HVAC Equipment Constraints
4.2.2.1
4.2.2.2
Outdoor Temperature:
Minimum:
C
Maximum:
4.2.2.3
Climatic conditions:
Winter dry bulb
4.3.1.3
4.3.1.4
USER REQUIREMENTS
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JETT
BIOREACTOR
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April 2005
4.3.3 Utilities
4.3.3.1
4.3.3.2
4.3.3.3
4.3.3.4
4.3.3.5
Related Discharges
4.3.3.4.1
Volume
4.3.3.4.2
pH
4.3.3.4.3
Temperature
4.3.3.4.4
Electricity
Materials
4.3.3.5.1
4.3.3.5.2
Phases
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
4.3.3.5.3
4.3.3.6
4.3.3.5.4
Control Air
4.3.3.6.1
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April 2005
Amperage
Uninterruptible Power Supply (Define Use)
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.
4.3.3.7
4.4
Availability
4.4.1 The Bioreactor is intended to be operated Continuously, __ hours per day, __
hours per week.
4.4.2 Operation of the Bioreactor 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 Product Contact Materials
Describe any local procedural requirements such as local standards, which
must be adhered to if applicable.
4.5.1.1
All piping welds and product contact welds shall meet ASME and
3A specification requirements.
4.5.1.2 Product contact metal to be (316L Stainless Steel, 316 Stainless
Steel, 304 Stainless Steel, etc.)
4.5.1.3 List critical requirements for surface finish, roughness, etc.
4.5.1.4 Other standards are attached.
The Supplier shall adhere to the indicated sections only.
4.5.2 Product in Contact with Materials
All product contact parts should be considered.
4.5.2.1
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
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April 2005
Explosion Protection
This section is only valid if the product being used is highly
reactive. Insert containment guidelines here (i.e. Bar Construction
with isolation and suppression, 10 Bar construction with isolation
only, Closed-Loop Nitrogen System, etc.).
4.5.6 Labeling
All equipment and control wiring shall be labeled and identified.
4.6
Maintenance
Describe the expected hardware and software maintenance support including: ease
of maintenance, expansion capability (software only), likely enhancements
(software only), expected lifetime and long-term support.
4.6.1.1
4.6.1.2
4.6.1.3
4.6.1.4
4.6.1.5
4.6.1.6
USER REQUIREMENTS
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JETT
BIOREACTOR
4.6.1.7
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April 2005
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.
5.1.1 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 Users review.
5.1.2 The Supplier shall provide a Project Manager for the project to provide a
single communication point with the User.
5.1.3 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.
5.2.1 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.
5.2.2 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.
5.2.3 The User shall notify the Supplier of the length of runs required, special
materials required, and any other unique test requirements _______ weeks
in advance of the start of testing.
Refer to the Equipment Validation Plan for applicable procedures.
5.3 Delivery
The Bioreactor, with all options, equipment, and the documentation listed below,
shall be delivered to the Users receiving dock.
5.3.1 Documentation
5.3.1.1
5.3.1.2
USER REQUIREMENTS
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JETT
BIOREACTOR
5.3.1.3
5.3.1.4
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Project Plan
Functional Specification/Requirement
Design Specifications
Controls Test
Operational Test
Instrument Listing
Control Schematics
Bill of Materials
USER REQUIREMENTS
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BIOREACTOR
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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
5.4.2.1.2
Replacement Parts Availability List (Normal lead
times shall be listed)
5.4.2.2 User Site Support
5.4.2.2.1
5.4.2.2.2
USER REQUIREMENTS
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JETT
BIOREACTOR
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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
C
CFR
dB
EMI
ft
Definition
Degrees Celsius
Code of Federal Regulations
Decibels
Electro-Magnetic Interference
Feet
GUI
HVAC
ISO
JETT
LEL
NEC
OIT
RFI
URS
USER REQUIREMENTS
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BIOREACTOR
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7.0 REFERENCES
List references that were used in preparing this document or that provide additional
details, such as:
7.1 Equipment Validation Plan
7.2 Current revision of GAMP Guidelines
7.3 Vendor Piping Certification (if applicable)
7.4 Customer Connection Diagram
7.5 Approved Instrumentation List
7.6 Process Flow Diagram
7.7 21 CFR Part 11
7.8 National Electric Code
7.9 S88
USER REQUIREMENTS
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BIOREACTOR
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8.0 APPROVAL
Insert your companys 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.
JETT
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
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9.0 ATTACHMENTS