BioreactorURSA1.docx
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BioreactorURSA1.docx
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BioreactorURSA1
UserRequirementsTemplate
foraBIOREACTORSYSTEM
REVISIONHISTORY
Rev.
Date
DevelopedBy:
RevisionSummary
A1
4/5/2005
JEG
InitialReleaseusingJETTBLANKURSTEMPLATE_Rev3
Note:
Foraninitialrelease,provideanotethatthedocumentisbeingroutedforinitialreview/approval.
(ReminderofPageIntentionallyLeftBlank)
TableofContents
ProjectNo.:
InserttheuniqueprojectnumberassociatedwiththisparticularURS.
DocumentNo.:
InserttheDocumentIdentificationNumberandRevision.
DocumentDescription:
BIOREACTORSYSTEM,JETTExampleBlankUserRequirementsSpecificationTemplateRev.3.
1.0Introduction(SCope)
ThisdocumentdefinesonlytheuserrequirementsfortheBioreactorSystem.ElectronicRecordsandElectronicSignature(ER/ES),securityandothertypesofcommonrequirements,aswellasuserrequirementsofotherprocesscells,arecoveredelsewhereintheSystemLevelUserRequirementsSpecificationsfortheProcessControlSystem.
DelegatefromJacobsEngineeringGroup,Inc.istheauthor.Thedocumentisthefirststepintheprojectlifecycleandclarifiesthegoalsofthisproject.Thislifecycleconsistsofkeyqualitydeliverablesdocumentingthedesign,developmentandimplementationoftheBioreactorSystem.
ThisdocumentwillonlycoverthetypicaluserprocessrequirementsfortheBioreactorSkid,BioreactorUtilitySkidandancillaryequipment.
RefertotheEquipmentValidationPlanthatoutlinestheSupplier’sresponsibilitiesasattached.
Thisistobeutilizedasaguidefortheusertoanswerthemajorityofquestionsinvolvedinspecifyingthe“what”fortheequipment.Addendumsmaybeusedtoroundouttherequirements.
2.0Overview
ThisdocumentencompassesthenormalrangeoftheBioreactorSystemandancillaryequipmentoperations.
2.1Use:
Describewhatapplicationstheequipment/systemwillbeusedtosupport.Includeabriefexplanationofthegeneralfunctions.
2.1.1ThepurposeoftheBioreactorSystemistoperformcellgrowthinacontrolledenvironmenttoquantityandconcentrationsuitableforharvest.TheBioreactorislocatedintheprocessareaandwillbeoperatedinbatchmode.Productwillbetransferredfromheretothepurificationsuite.ItcanalsobediscardedtoBiowaste.
2.1.2Cellsaretransferredintothemediafilledbatchreactorviaairpressureandarethenculturedinthebioreactorsystemunderclosedconditions.Theinoculumforthisreactorisgrowninthebioreactorandispneumaticallytransferredintothedownstreamprocess.MediacanbesuppliedtothisreactorfromanyoftheMediaPreparationVesselsthroughaseriesoftransferpanels.Caustic,Antifoam,andnutrientsaresuppliedfromPortableVessels,usingeitherperistalticpumpsorairpressuretoaccomplishthetransfer.
2.1.3Themassspectrometeranalyzesthebioreactorsparge,overlay,andventgases.SamplesofthebioreactorcultureareanalyzedintheQualitylabforcelldensity,pH,andviability.Thesterilitylabisusedtotestthesterilityoftheculture.
2.2Capacity:
Provideabriefdescriptionoftheequipment/systemcapacityrequirements.
2.2.1TheequipmentshallbecapableofproducingXYZproductcontinuously,overan8-hourshift.
3.0OperationalRequirements
ThisSectionshallstatetheoperationalrequirements:
systemfunctions,dataandinterfaces.Itshallalsodefinetheenvironmentinwhichthesystemmustoperate.Criticalrequirementsshallbespecificallyidentifiedassuch.Includeprocessdescriptionsandflowchartsasappropriate.
3.1Capacity
3.1.1Rangeofproducts
3.1.2Commoditiestobeused(i.e.vials,bottles,tablets,etc.)
3.1.3ProcessedMaterialstobeusedorinvolved
3.1.4Productionrates
3.2
ProcessRequirements
3.2.1Qualityofproductsandconcentrations
3.2.2Productlimitations(i.e.temperature,humidity,pH,etc.)
3.3ProcessControl
3.3.1MeasurementRange
MeasurableVariable
MeasurementLocation
MeasurementRange&DisplayResolution
Accuracy
Temperature
Vessel
0to150.0°C
0.25°C
Temperature
Jacket
0to150.0°C
0.25°C
AgitatorSpeed
AgitatorDrive
0to80.0rpm
1%FS
Pressure
Vessel
0to50.0psig
0.2psig
pH_1
Vessel
2to13.0pH
1%FS
pH_2
Vessel
2to13.0pH
1%FS
DO_1
Vessel
0to200.0%sat
1%FS
DO_2
Vessel
0to200.0%sat
1%FS
CD_1
Vessel
0to15millioncells/ml
5%FS
CD_2
Vessel
0to15millioncells/ml
5%FS
OverlayAir
Airinletgroup
0to500slpm
1%FS
O2-Flow
Airinletgroup
0to50.0slpm
1%FS
SpargeAir
Airinletgroup
0to50.0slpm
1%FS
CO2-Flow
Airinletgroup
0to100.0slpm
1%FS
MediaMassFlow
MediaFeed
0to5.0kg/minute
1%FS
Temperature
InoculumTrap
0to150.0°C
0.3°C
Temperature
RetentateTrap
0to150.0°C
0.3°C
Temperature
SampleTrap
0to150.0°C
0.3°C
Temperature
BioreactorSeal
0to150.0°C
0.3°C
Temperature
Permeate1Trap
0to150.0°C
0.3°C
Temperature
Permeate2Trap
0to150.0°C
0.3°C
Temperature
CellFreeLP
0to150.0°C
0.3°C
Temperature
WholeCellLP
0to150.0°C
0.3°C
3.3.2SetpointRange
Setpoint
MeasurementLocation
Minimum
Maximum
Temperature
Vessel
Temperature
Jacket
AgitatorSpeed
AgitatorDrive
Pressure
Vessel
pH_1
Vessel
pH_2
Vessel
OverlayAir
Airinletgroup
O2-Flow
Airinletgroup
SpargeAir
Airinletgroup
CO2-Flow
Airinletgroup
MediaMassFlow
MediaFeed
Temperature
InoculumTrap
Temperature
RetentateTrap
Temperature
SampleTrap
Temperature
BioreactorSeal
Temperature
Permeate1Trap
Temperature
Permeate2Trap
Temperature
CellFreeLP
Temperature
WholeCellLP
3.3.3ParameterControlTolerance
Note:
Ataminimum,listthecritical,processparameters.Considerdocumentinghoweachoftheparameterrequirementswasdetermined.
Parameter
MeasurementLocation
ControlTolerance
Temperature
Vessel
+0.5oC
Temperature
Jacket
+0.5oC
AgitatorSpeed
AgitatorDrive
+10RPM
Pressure
Vessel
+2psi
pH_1
Vessel
+0.1
pH_2
Vessel
+0.1
OverlayAir
Airinletgroup
+0.1
O2-Flow
Airinletgroup
+0.1
SpargeAir
Airinletgroup
+0.1
CO2-Flow
Airinletgroup
+0.1
MediaMassFlow
MediaFeed
+0.1
Temperature
InoculumTrap
+0.5oC
Temperature
RetentateTrap
+0.5oC
Temperature
SampleTrap
+0.5oC
Temperature
BioreactorSeal
+0.5oC
Temperature
Permeate1Trap
+0.5oC
Temperature
Permeate2Trap
+0.5oC
Temperature
CellFreeLP
+0.5oC
Temperature
WholeCellLP
+0.5oC
3.4Functions
3.4.1Operation
3.4.1.1Thesystemshalloperatewithaminimumofoperatorinvolvement.Operationshallbesafefromanoperatorandenvironmentalstandpoint.
3.4.1.2Thesystemshallbeoperatedlocallyattheequipmentitselfbymeansoftheoperatorinterfaceterminal(OIT).
3.4.2Controlsystemrequirements
AllcontrolloopsareimplementedinthePLC,usingavailablecontrollerstructuresdependinguponthetypeofprocessvariable.ThePLCcontrolloopblockscanbeconfiguredtoperformPIDcontrol,Setpointcontrol,(Multiple)cascadecontrol,Timercontrol,andcombinations.Setpoints,alarmlimits,andminimumandmaximumoutputlimitsarerecipevariablesthatcanbedownloadedfromtheProcessControlSystem
3.4.2ControlLoops
3.4.2.1MediaInitialCharge,BatchFeeds
Thesystemcanbefedbyapumpataflowraterangeof0to2lpm.Thesystemcanbefedbyameansofapressurizedportabletransfervessel.Toteandcontainerfeedstothesystemaremeasurableandcontrollablebymeansofweightusingloadcellswithatoleranceof+2kg.
3.4.2.2TemperatureControl
Theprocesstemperatureismeasurableandcontrollabletoarangeof25.0oCto42.0oC+0.5oCforaperiodof8hours.Theunitabletocooldowntolessthan8.0oC
3.4.2.3AgitatorSpeedControl
Theagitationspeedismeasurableandcontrollabletoarangeof10RPMto200RPM+10RPM.
3.4.2.4DissolvedOxygenControl
Thedissolvedoxygenofthesystemismeasurable.
3.4.2.5pHControl
ThepHofthesystemcontentismeasurableandcontrollabletoasetpoint+0.1.
3.4.2.6RetentateRecirculationPumpSpeedControl
TheRetentateRecirculationPumpSpeedismeasurableandcontrollable,flowraterangeof0to2lpm.
3.4.2.7
GasFlowRates
Overlaygasesofairandcarbondioxidetobeprovidedatameasurableandcontrollableflowraterangeof0to10slpmforairand0to2slpmforcarbondioxide.Air,carbondioxide,oxygen,andnitrogenwillbeprovidedforspargingandflowrateswillbemeasurableandcontrolled.Flowrateswillbe0to5slpmforair,2slpmforcarbondioxide,0to15slpmforoxygenand0to20slpmfornitrogen.
3.4.2.8PressureControl
Thesystembackpressureismeasurableandcanbecontrolledat2to30psi+2psi.
3.4.2.9PressureHold
Thevesselhastheabilityholdpressure.Pressurizethevesseltoabout30±3psigwithairornitrogen.Monitorthepressurechange,usingthevesselinstrumentationoraseparategauge,overan8-hourholdperiod.Nomorethan10%shouldbelostineighthours.
3.4.2.10CleaninPlace(CIP)
Theunitsurfacesaretobecleanable.Surfaceimperfections,crevices,gouges,obviouspits,etc.,aretobeeliminatedwheneverfeasible.Theequipmentistobefullydrainableandfreeofpocketsandtrapswhereliquidsmaybeheldup.Cleaningsolutionsmustreachallinternalandrecessedsurfaceareasatsufficientvelocityandturbulencetoensuretheremovalofsoilsordepositsbychemicaland/ormechanicalcleaning.
3.4.2.11SteaminPlace(SIP)
TheunitisabletoSIPandmaintainasterilizationtemperatureofnolessthan121.0oCfornolessthan24m
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