Биореактор

JETT
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
Page 1 of 30
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BIOREACTOR URS A1
April 2005
USER REQUIREMENTS TEMPLATE
FOR A BIOREACTOR SYSTEM
JOINT EQUIPMENT TRANSITION TEAM
JETT
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
Page 2 of 30
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BIOREACTOR URS A1
April 2005
REVISION HISTORY
Rev.
A1
Note:
Date
4/5/2005
Developed By:
JEG
Revision Summary
Initial Release using JETT BLANK URS
TEMPLATE_Rev3
For an initial release, provide a note that the document is being routed for initial
review/approval.
(Reminder of Page Intentionally Left Blank)
JOINT EQUIPMENT TRANSITION TEAM
JETT
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
Page 3 of 30
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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.............................................................................................................. 19
4.1
MILESTONES AND TIMELINES ...................................................................................... 19
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
JOINT EQUIPMENT TRANSITION TEAM
JETT
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
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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.
1.0
INTRODUCTION (SCOPE)
This document defines only the user requirements for the Bioreactor System. Electronic
Records and Electronic Signature (ER/ES), security and other types of common
requirements, as well as user requirements of other process cells, are covered elsewhere
in the System Level User Requirements Specifications for the Process Control System.
Delegate from Jacobs Engineering Group, Inc. is the author. The document is the first
step in the project life cycle and clarifies the goals of this project. This life cycle consists
of key quality deliverables documenting the design, development and implementation of
the Bioreactor System.
This document will only cover the typical user process requirements for the Bioreactor
Skid, Bioreactor Utility Skid and ancillary equipment.
Refer to the Equipment Validation Plan that outlines the Supplier’s responsibilities as
attached.
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.
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USER REQUIREMENTS
SPECIFICATION
JETT
2.0
BIOREACTOR
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April 2005
OVERVIEW
This document encompasses the normal range of the Bioreactor System and ancillary
equipment operations.
2.1
Use: Describe what applications the equipment/system will be used to support.
Include a brief explanation of the general functions.
2.1.1
The purpose of the Bioreactor System is to perform cell growth in a
controlled environment to quantity and concentration suitable for harvest.
The Bioreactor is located in the process area and will be operated in batch
mode. Product will be transferred from here to the purification suite. It
can also be discarded to Biowaste.
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
3.0
Capacity: Provide a brief description of the equipment/system capacity
requirements.
2.2.1 The equipment shall be capable of producing XYZ product continuously,
over an 8-hour shift.
OPERATIONAL REQUIREMENTS
This Section shall state the operational requirements: system functions, data and
interfaces. It shall also define the environment in which the system must operate.
Critical requirements shall be specifically identified as such. Include process descriptions
and flowcharts as appropriate.
3.1
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
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3.2
3.3
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USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
Process Requirements
3.2.1
Quality of products and concentrations
3.2.2
Product limitations (i.e. temperature, humidity, pH, etc.)
Process Control
3.3.1
Measurement Range
Temperature
Vessel
Measurement Range &
Display Resolution
0 to 150.0 °C
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
Air inlet group
0 to 500 slpm
 1 %FS
O2-Flow
Air inlet group
0 to 50.0 slpm
 1 %FS
Sparge Air
Air inlet group
0 to 50.0 slpm
 1 %FS
CO2-Flow
Air inlet group
0 to 100.0 slpm
 1 %FS
Media Mass Flow
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
Minimum
Maximum
Measurable Variable Measurement Location
3.3.2
Accuracy
 0.25 °C
Setpoint Range
Setpoint
Temperature
Temperature
Agitator Speed
Pressure
pH_1
Measurement
Location
Vessel
Jacket
Agitator Drive
Vessel
Vessel
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April 2005
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
Setpoint
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
Minimum
Maximum
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
Parameter Control Tolerance
Note: At a minimum, list the critical, process parameters. Consider
documenting how each of the parameter requirements was determined.
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
JOINT EQUIPMENT TRANSITION TEAM
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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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).
3.4.2
Control system requirements
All control loops are implemented in the PLC, using available controller
structures depending upon the type of process variable. The PLC control
loop blocks can be configured to perform PID control, Setpoint control,
(Multiple) cascade control, Timer control, and combinations. Setpoints,
alarm limits, and minimum and maximum output limits are recipe
variables that can be downloaded from the Process Control System
3.4.2
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.
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JETT
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
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3.4.2.7 Gas Flow Rates
Overlay gases of air and carbon dioxide to be provided at a
measurable and controllable flow rate range of 0 to 10 slpm for air
and 0 to 2 slpm for carbon dioxide. Air, carbon dioxide, oxygen,
and nitrogen will be provided for sparging and flow rates will be
measurable and controlled. Flow rates will be 0 to 5 slpm for air, 2
slpm for carbon dioxide, 0 to 15 slpm for oxygen and 0 to 20 slpm
for nitrogen.
3.4.2.8 Pressure Control
The system back pressure is measurable and can be controlled at 2
to 30psi + 2 psi.
3.4.2.9 Pressure Hold
The vessel has the ability hold pressure. Pressurize the vessel to
about 30  3 psig with air or nitrogen. Monitor the pressure
change, using the vessel instrumentation or a separate gauge, over
an 8-hour hold period. No more than 10% should be lost in eight
hours.
3.4.2.10 Clean in Place (CIP)
The unit surfaces are to be cleanable. Surface imperfections,
crevices, gouges, obvious pits, etc., are to be eliminated whenever
feasible. The equipment is to be fully drainable and free of
pockets and traps where liquids may be held up. Cleaning solutions
must reach all internal and recessed surface areas at sufficient
velocity and turbulence to ensure the removal of soils or deposits
by chemical and/or mechanical cleaning.
3.4.2.11 Steam in Place (SIP)
The unit is able to SIP and maintain a sterilization temperature of
no less than 121.0 oC for no less than 24 minutes and meets Fo of
greater than 24 for sterilization and inactivation.
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April 2005
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
3.4.2.12 Sequence of Operation
The unit is capable of full automation during the following process
steps (Note: The term Process Operation is taken from the Process Model of
the ISA S88.01 Batch Control standard. This section is organized in the order of
units that the product passes through. Within each unit subsection, the Process
Operations are identified with all of the associated Process Actions, Failure
Conditions, etc. Each Process Operation will ultimately be achieved by a Recipe
Operation that contains a single phase or series of phases.)
CIP Vessel
Pre-SIP Leak Test
SIP Vessel
Cool Equipment and Establish Sterile Blocks
Prep and Transfer Media
Inoculate Bioreactor
Growth - Addition Feeds
Sample Vessel
Harvest Transfer
Discard to BW
WFI Flush
WFI Flush
Thermal Inactivation
Thermal Inactivation
CIP Vessel
CIP Vessel
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USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
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3.4.3 Power failure/Recovery
3.4.3.1
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:
3.4.3.2
3.4.3.1.1
Personnel
3.4.3.1.2
Equipment
3.4.3.1.3
Product
Recovery Methods: Insert your specific recovery scheme here.
For example:
3.4.3.2.1
Manually re-start based on operator inputs (Operator
initiates power recovery sequence).
3.4.3.2.2
Re-start based on last state before loss of power.
(System runs through power recovery sequence when
operator start signal is given)
3.4.3.2.3
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).
3.4.4 “Emergency Stop”
Insert your specific “Emergency Stop” (E-Stop) strategy and
communication scheme here.
For example:
3.4.5.1 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 easily accessible areas around the
equipment as required by national and local safety standards.
3.4.5 Alarms and Warnings
3.4.5.1
“Critical alarms” - Insert your specific “Critical Alarm” action
scheme here.
For example:
3.4.5.1.1
Critical Alarms shall take action via interlock(s)
and/or operator procedural response to shut the
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USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
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.
3.4.5.2
“Informational Messages” shall notify the operator and take no
further action.
Note: For a customized equipment application, include an alarm
table, like the example that follows.
For example:
3.4.5.2.1
The Equipment shall have the following critical
alarms and warnings:
Critical
Alarm
Stackpole
Light
Illumination
(color/flashing)
Informational
Message
Interlock(s)
Operator
Procedural
Emergency Stop
X
X
X
X
X
Control Platform
Communication Watchdog
X
X
X
X
Control Power Fault
X
X
X
X
Main Air Fault
X
X
X
High Vessel Level
X
X
X
X
Low Vessel Level
X
X
X
X
High Temperature
X
X
X
X
Low Temperature
X
X
X
X
Deviation Temperature
X
X
X
High Agitation Speed
X
X
X
X
Low Agitation Speed
X
X
X
X
Deviation Agitation Speed
X
X
X
High DO
X
X
X
X
Low DO
X
X
X
X
Deviation DO
X
X
X
High pH
X
X
X
X
Low pH
X
X
X
X
Deviation pH
X
X
X
Alarm or Informational Message
Response
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USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
Alarm or Informational Message
Critical
Alarm
Stackpole
Light
Illumination
(color/flashing)
Response
Informational
Message
Interlock(s)
Operator
Procedural
High Air Flow
X
X
X
X
Low Air Flow
X
X
X
X
Deviation Air Flow
X
X
X
High Carbon Dioxide Flow
X
X
X
X
Low Carbon Dioxide Flow
X
X
X
X
Deviation Carbon Dioxide
Flow
X
X
X
High Oxygen Flow
X
X
X
X
Low Oxygen Flow
X
X
X
X
Deviation Oxygen Flow
X
X
X
High Nitrogen Flow
X
X
X
X
Low Nitrogen Flow
X
X
X
X
Deviation Nitrogen Flow
X
X
X
Rupture Disc Failure
X
X
X
X
Motor Faults
X
X
X
CONTROL PLATFORM
Battery Low Warning
X
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.
Note: Consider documenting how “critical and informational message”
criterions were determined.
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USER REQUIREMENTS
SPECIFICATION
JETT
3.5
BIOREACTOR
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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.
3.5.1
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
User interface access levels
Frequency of data point collection
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. Security for data
and operator access is provided by (User ID/Password, Card
Reader, Biometric (Fingerprint, eye scan, voice recognition, etc.).
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USER REQUIREMENTS
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BIOREACTOR
3.5.4
User Interface with Supervisors and Operators
Insert your interface scheme here.
For example:
3.5.4.1 The CONTROL PLATFORM system shall include interfaces
with the Operator and Supervisor that ensures easy, safe, and
reliable operation.
3.5.4.2 An operator-interface terminal 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.
3.5.5 Language requirements
Specify language that information will be displayed in (i.e. English,
Spanish, German, Bilingual, etc.)
3.5.5.1
Displayed Requirements:
State the system of measurement that will be used (English or
Metric (S.I.)).
Parameter
Format
Unit(s) of measurement
Temperature
(###.#) units
units
YYYYYYY
(##)%
%
3.5.6 Interface with Other Equipment
The control system shall include the interfaces necessary to facilitate
operation and configuration. For example:
3.5.6.1
A proprietary communications port (i.e. DH+, Modbus, etc.) shall
be provided.
3.5.6.2 An Ethernet communications port shall be provided.
3.5.6.3 A high-speed configuration/monitoring connection shall be
provided.
3.5.7 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.).
JOINT EQUIPMENT TRANSITION TEAM
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
3.5.8 Data Collection
Consider any archiving and reporting requirements here.
3.5.8.1
3.5.8.2
3.5.8.3
3.5.8.4
3.5.8.5
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
3.5.8.13
3.5.8.14
3.5.8.15
3.5.8.16
3.5.8.17
Temperature
Agitator Speed
Dissolved Oxygen
pH
Air Flow
Carbon Dioxide Flow
Oxygen Flow
Nitrogen Flow
CIP Flow
CIP Pressure
SIP Temperature
SIP Time
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Remote Device Control
Acknowledge Alarms
X
X
X
X
X
Enable/Disable Alarms
None Operator
Supervisor
Engineer / Maint.
Administrator
Change Alarm Setpoints,
Time Delay and Dead band
Access Level
Screen Navigation
Change Device Mode to
Auto
Change Device Mode to
Hand or Off
BIOREACTOR
Change PID Loop Setpoints
and Modes
JETT
Change Analog Output
Value
Change Analog Output
Mode
Change PID Loop Gain,
Rate and Reset Constraints
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USER REQUIREMENTS
SPECIFICATION
X
X
X
X
USER REQUIREMENTS
SPECIFICATION
JETT
3.6
BIOREACTOR
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Environment
Provide details of the physical environment in which the Bioreactor will be
operated.
3.6.1 Layout
For example:
3.6.1.1
Allocated floor space for the equipment is _____ inches by
________ inches with at least a _______inch corridor around the
periphery for the equipment.
3.6.1.2 Vertical clearance is _________ inches.
3.6.1.3 Floor Loading is
pounds/ft2
3.6.1.4 See attached drawing #________________________ (if
applicable).
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 Explosion Classification
List the critical explosion requirements for the room.
3.6.2.1.1
3.6.2.2
3.6.2.3
Room will be non-hazardous
Environmental Classification
List the critical air quality requirements for the environment.
3.6.2.2.1
ISO Class 5, 7, or 8 (ISO 14644-1 and ISO 146442)
3.6.2.2.2
Class A, B, C, or D (The Rules Governing
Medicinal Products in the European Union – Annex
1)
3.6.2.2.3
Directional airflow
3.6.2.2.4
Airflow velocity
3.6.2.2.5
Number of air changes
3.6.2.2.6
Particle Ingress
Biohazard Level
List the critical biohazard level requirements for the environment.
3.6.2.3.1
BL-1
3.6.2.3.2
BL-2
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USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
3.6.2.4
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April 2005
Rating of enclosures
List the rating requirements for enclosures in the environment.
3.6.2.4.1
NEMA 4X (Wash down and non-Corrosive)
3.6.3 Cleaning Requirements


Automated CIP or manual cleaning.
Use existing or centralized CIP system or system dedicated to this
equipment.
 Describe how cleaning process is to be initiated and controlled, i.e.
locally or remotely.
 Describe any remote control requirements, such as CIP Start, Stop,
Abort, etc.
3.6.4 Sterilization Requirements
Describe the type of sterilization that will be performed on or within the
Bioreactor and the duration the Bioreactor system will be exposed.



Automated SIP (sterilize-in-place) or manual sterilization.
Describe steam sterilization requirements if any.
Describe how sterilization process is to be initiated and controlled, i.e.
locally or remotely.
3.6.5 Intended Operating Environment:
Describe the type of operating environment that the Bioreactor will be
exposed to following installation.
For example:
3.6.5.1
3.6.5.2
3.6.5.3
The Bioreactor shall be mounted in a GMP environment with a
temperature range of 15 to 25 °C, non-condensing humidity.
Vibration levels in operating environment are <Negligible, Slight,
or Severe>
The Seismic Zone in the operating environment is <Zone 1, Zone
2, Zone 3, Zone 4, or Zone 4A>.
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JETT
4.0
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USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
CONSTRAINTS
4.1
Milestones and Timelines
Based on the model outlined below, establish the project milestones with a timeline:
JETT EQUIPMENT ACQUISITION MODEL
SUPPLIER
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
Proposal
P.O.
Engineering Feasibility Study
and Results
Proposal
• Quality & Validation Plan • Project Plan
Functional
Specification
(traceable to URS)
Approval
Review Functional Specification
Detailed Design
Documentation
(traceable to Functional Specification)
Review Detailed Design
Review System
Acceptance Test Specifications
Integrate with Validation
Documentation as appropriate
Approval
System Acceptance Test
Specifications (IQ/OQ)
• Hardware
Approval
• Software
System Acceptance
Testing and Results
User Witness Optional
Maintenance & Support
Documentation
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JETT
4.2
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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
Process air enters in from…
Indoor Temperature:
C
4.2.2.2
Outdoor Temperature:
Minimum:
C
Maximum:
4.2.2.3
C
Climatic conditions:
Winter dry bulb
C
Winter wet bulb
C
Summer dry bulb
C
Summer wet bulb
C
4.2.3 Equipment Generated Vibration
The maximum allowable equipment vibration generated during operation is
<value>.
4.3
Compatibility 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
4.3.1.1
4.3.1.2
4.3.1.3
4.3.1.4
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
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USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
Page 21 of 30
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April 2005
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
4.3.2.1
4.3.2.2
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.
4.3.3 Utilities
4.3.3.1
4.3.3.2
4.3.3.3
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
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
______ VAC ____ Hertz
4.3.3.5.2
Phases
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USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
4.3.3.5.3
4.3.3.6
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April 2005
Amperage
4.3.3.5.4
Uninterruptible Power Supply (Define Use)
Control Air
4.3.3.6.1
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
Other Utility Requirements
Provide details regarding any other utility systems that are
required to support operation of the equipment/system.
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
The Bioreactor will be used for (aqueous solutions, low LEL
(lower explosion limit) solvents, high LEL solvents, etc.).
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SPECIFICATION
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BIOREACTOR
Page 23 of 30
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4.5.3 Noise Level Constraints
Insert your own noise level constraint requirements here.
For example:
The noise level generated during operation of the Bioreactor will not exceed
85 dB from 3 feet away.
4.5.4 EMI / RFI levels are:
Insert your own electrical and radio noise immunity requirements here.
For example:
The Bioreactor will not be used in an area where two-way radio
communication devices are in operation. The Bioreactor shall meet CE
requirements for electrical noise immunity and emissions.
4.5.5 Containment
4.5.5.1
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
System shall be maintained on a schedule as indicated by the
supplier.
4.6.1.2
Supplier is to provide (at minimum) the following maintenance
instructions:
4.6.1.3
All sub-systems provided (Maintenance and operation manuals of
vendor equipment)
4.6.1.4
A comprehensive lubrication list and recommended lubrication
schedule
4.6.1.5
A comprehensive recommended maintenance (regular
recommended inspection intervals, wear points, recommended
spare parts list)
4.6.1.6
Supplier shall supply ______ Copies of Operation, Installation,
Maintenance and de-commissioning manuals
JOINT EQUIPMENT TRANSITION TEAM
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
4.6.1.7
5.0
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Accessibility for operation and maintenance personnel.
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 User’s 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 User’s receiving dock.
5.3.1 Documentation
5.3.1.1
5.3.1.2
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
JOINT EQUIPMENT TRANSITION TEAM
USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
5.3.1.3
5.3.1.4
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April 2005
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 2002 (*.doc)

User Requirements Specification
Microsoft Word 2002 (*.doc)

Functional Specification/Requirement
Microsoft Word 2002 (*.doc)

Design Specifications
Microsoft Word 2002 (*.doc)

Controls Test
Microsoft Word 2002 (*.doc)

Hardware Installation Test
Microsoft Word 2002 (*.doc)

Operational Test
Microsoft Word 2002 (*.doc)

Factory Acceptance Test
Microsoft Word 2002 (*.doc)

Operator, Maintenance and Service Manuals
Microsoft Word 2002 (*.doc)

Process and Instrumentation Diagram (P&ID)
AutoCAD version 2002 (*.dxf)

Instrument Listing
Microsoft Word 2002 (*.doc) or Excel 2002 (*.xls)

Control Schematics
AutoCAD version 2002 (*.dxf)

Control Panel Assembly Drawings
AutoCAD version 2002 (*.dxf)

Equipment Assembly Drawings
AutoCAD version 2002 (*.dxf)

Bill of Materials
Microsoft Word 2002 (*.doc) or Excel 2002 (*.xls)

Spare Parts List
Microsoft Word 2002 (*.doc) or Excel 2002 (*.xls)

Component Cut Sheets
Microsoft Word 2002 (*.doc) or Excel 2002 (*.xls)

CONTROL PLATFORM Program Printout and Disk
File
XXX Program Development format

OIP Configuration Printout and Disk File
XXX Program Development format
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USER REQUIREMENTS
SPECIFICATION
JETT
BIOREACTOR
Page 26 of 30
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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
Start-up Support (list available options)
5.4.2
5.4.1.1
Training (list training options available)
Post Start-up Support (list post-startup support available)
5.4.2.1 Technical Support
5.4.2.1.1
Telephone (Voice or Modem)
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
Preventative Maintenance (list maintenance
contracts available)
5.4.2.2.2
System Improvements (supplier shall notify user of
any improvements available on a regular basis)
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USER REQUIREMENTS
SPECIFICATION
JETT
6.0
BIOREACTOR
Page 27 of 30
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April 2005
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
Degrees Celsius
CFR
Code of Federal Regulations
dB
Decibels
EMI
Electro-Magnetic Interference
ft
Feet
GUI
Graphic User Interface
HVAC
Heating, Ventilation, and Air Conditioning
ISO
International Organization for Standardization
JETT
Joint Equipment Transition Team
LEL
Lower Explosion Limit
NEC
National Electric Code
OIT
Operator Interface Terminal
RFI
Radio Frequency Interference
URS
User Requirement Specification
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JETT
7.0
USER REQUIREMENTS
SPECIFICATION
BIOREACTOR
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REFERENCES
List references that were used in preparing this document or that provide additional
details, such as:
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.9
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
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USER REQUIREMENTS
SPECIFICATION
JETT
8.0
BIOREACTOR
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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.
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JETT
9.0
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SPECIFICATION
BIOREACTOR
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ATTACHMENTS
JOINT EQUIPMENT TRANSITION TEAM