JETTCentrifug URS.docx
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JETTCentrifug URS.docx
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JETTCentrifugURS
UserRequirementsTemplate
foraCentrifuge
REVISIONHISTORY
Rev.
Date
Approval
RevisionSummary
A1
03/26/02
CAR
InitialDraft–ContentprovidedbyHeinkelFilteringSystems,Inc.(InputfromHeinkelobtainedbyCARoerig)
OriginalinformationwasorganizedintothecurrentURStemplatebyPerformanceSolutions(MTFilary).CarriedovertextandsetupfromtheLabelRewinderURSdevelopedbyPaulCoury.
A2
5/14/02
DAN
RevisedrevisionA1attheApril18,2002JETTmeeting(DaleNoteboom,MarievaRivera,RusselRegan,andVinceMiller)
InformationfromthemeetingwascollectedandincorporatedbyPerformanceSolutions(MTFilary)on5/14/02.
(RemainderofPageIntentionallyLeftBlank)
TableofContents
1.0Introduction4
2.0Overview5
2.1SystemBenefits6
2.2Use6
2.3OperationalCapacity7
3.0OperationalRequirements7
3.1Capacity7
3.2ProcessRequirements7
3.3ProcessControl8
3.4Functions8
3.5DataandSecurity19
3.6Environment22
4.0Constraints26
4.1MilestonesandTimelines26
4.2EquipmentConstraints27
4.3CompatibilityandSupport28
4.4Availability30
4.5ProceduralConstraints30
4.6Maintenance31
5.0Life-Cycle33
5.1Development33
5.2Testing33
5.3Delivery33
5.4Support35
6.0Glossary37
7.0References40
8.0Approval41
(RemainderofPageIntentionallyLeftBlank)
ProjectNo.:
InserttheuniqueprojectnumberassociatedwiththisparticularURS.
DocumentNo.:
InserttheDocumentIdentificationNumberandRevision.
DocumentDescription:
CentrifugeUserRequirementsSpecification.
1.0Introduction
Note:
Insertyourowndescriptionandintroduction.Youmaywishtoincludeyourownrequirementsandspecificstoallowtheinexperiencedreader,contractors,andsuppliersadequateexplanationtounderstandthescopeoftheequipment.
Describewhoproducedthedocument,underwhatauthority,andforwhatpurpose.
Describethecontractualstatusofthedocument.Includeorreferenceasanattachmentthe“legal”paragraphthatcommunicatespurchasingtermsandconditionsinthissection.
Describetherelationshipofthisdocumenttootherdocuments.ThisisimportantforequipmentthatispartofanintegratedprocessorlineandwillhelptheSuppliertounderstandandaskquestionsthatmayotherwisebeoverlooked.
RefertotheEquipmentValidationPlanthatoutlinestheSupplier’sresponsibilitiesisattached.
Removeanyoptionsthatarenotapplicableforthisproject,ifotheruseswillapplylisteachseparately.
Thisistobeutilizedasaguidefortheusertoanswerthemajorityofquestionsinvolvedinspecifyingthe“what”fortheequipment.Addendumsmaybeusedtoroundouttherequirements.
ForExample:
Thisdocumentwasgeneratedundertheauthorityofthe___________________Companyforthepurposeofspecifyingtheuserrequirementforacentrifuge.Thecentrifugeistobeusedtoseparatesolidparticles,generallygreaterthan1microninsizefromaliquidstream.
1.1Thisuserrequirementspecificationwillberecognizedasanintegralpartoftheprocurementagreementwiththeselectedequipmentvendor.Theequipmentsupplierorvendorwillabidebytheinformationandconditionssetforthbythisdocumentaswellasthestandardpurchasingtermandconditionsofthe____________________Company.
1.2Thecentrifugewillbeoperatedindependentlyofotherequipmentandsystemsandwillbelocatedinadesignatedoperatingarea.
1.3Anequipmentvalidationplanhasbeendevelopedtooutlinetheplannedtasksandexpectationsforvalidationofthecentrifuge.ThisplanhasbeenincludedasAttachment_____.TheequipmentsupplierorvendorhasspecificresponsibilitiesasoutlinedbytheValidationPlanandthisdocument.
2.0Overview
Thisdocumentencompassesthenormalrangeofequipmentoperations.Thissectionprovidesahighleveldescriptionofthesystemexplainingwhyitisrequiredandwhatisrequiredofit.Includedarethebackground,keyobjectives,andthemainfunctionsandinterfaces.Obviously,technologyimprovementsandnewapplicationsmayrequiredeviationfromthistemplate.
TheUsershouldconsiderincludinginformationonthefollowing:
∙Use:
Describewhatapplicationstheequipment/systemwillbeusedtosupport.Includeabriefexplanationofthegeneralfunctions.
Forexample(foraWideRangeFiller):
Thewiderangefillerlineshallprocesspharmaceuticalvialsundersanitaryconditionswiththefollowingfunctions:
vialfilling,putstopperstovials,oxygenreduction,samplecheckweighing,andvialeject.
Forequipmentdealingwithsoliddosagepharmaceuticalproductsdirectly:
Theproductsbeingdevelopedonthespecifiedequipmentareof:
∙Lowactive(vitamins,supplements)
∙Mediumactive(e.g.Aspirin)
∙Highlyactive(e.g.Morphine)
∙Exclusive(e.g.Penicillin)
∙Capacity:
Provideabriefdescriptionoftheequipment/systemcapacityrequirements.
Forexample(foraWideRangeFiller):
TheequipmentshallbecapableofproducingXYZproductcontinuously,overan8-hourshift.
AdditionalExample:
2.1SystemBenefits
Theexpectedmajorbenefitsofthissystemwillbe:
2.1.1Minimalresidualproductwillbeleftonthefiltercloth.
2.1.2Reducedsolventemissions.
2.1.3Nooperatorcontactwiththesolidsorliquidswillberequiredduringnormaloperations.
2.1.4Thesystemwillbefullyautomaticandwillnotrequireoperatorsupervisionduringnormaloperations.
2.2Use
Thefollowingisadescriptionoftheapplicationstheequipment/systemwillbeusedtosupport.Includedisabriefexplanationofthegeneralfunctions.
Thissectionshouldbeexpandedtoprovideahighleveldescriptionofthesystemexplainingwhyitisrequiredandwhatisrequiredofit.Includethebackground,keyobjectives,andthemainfunctionsandinterfaces.Obviously,technologyimprovementsandnewapplicationsmayrequiredeviationfromthistemplate.
Thefollowingisadescriptionoftheapplicationstheequipment/systemwillbeusedtosupport.Includedisabriefdescriptionofthegeneralfunctions.
2.2.1Thesolids-liquidseparationprocesswilltakeplaceinsideacentrifuge.Aftertheliquidhasbeenremovedtothefullestextentpossibleortothefullestextentdesired,thesolidsshallbedischargedviaafilterclotheinversionprocess.
2.2.2APLCbasedcontrolsystemtocontrolthefilteringcycleandenforceinterlocksandpermissivestoprotectequipmentandpersonnel.AnOperatorInterfacePanel(OIP)displayandallowcontrolofmachinefunctions.Theoperationalstateofthemachine,systemalarms,status,etc.willbeshownontheOIP.
2.3OperationalCapacity
Thefollowingisabriefdescriptionoftheequipment/systemcapacityrequirements.
2.3.1Thecentrifugemustbecapableofcontinuousoperationovera_____shift,_____dayoperation,butmaybeoperatedintermittentlytosatisfythedemandsofOperations.
3.0OperationalRequirements
3.1Capacity
Thefollowingcapacityrelatedrequirementsaretobesatisfiedbythecentrifuge.
Thefollowingareitemstoconsiderincluding:
Rangeofproducts,batchsize,throughputrates,etc.
3.1.1
3.2ProcessRequirements
Thefollowingprocessrequirementsaretobesatisfiedbythecentrifuge.
Thefollowingareitemstoconsiderincluding:
Centrate(turbidityorparticleloading,cake(dryness),acceptablelevelofproductleftinunitafterdischarge,emissionreleasesduringoperation,productsconcentrations,productlimitations(i.e.temperature,humidity,pH,etc.),etc.
3.2.1
3.3ProcessControl
Thefollowingprocesscontrolrequirementsaretobesatisfiedbythecentrifuge.
Thefollowingareitemstoconsiderincluding:
MeasurementRange,SetpointRange,ParameterControlTolerance,etc.
Note:
Ataminimum,listthecritical,processparameters.Considerdocumentinghoweachoftheparameterrequirementswasdetermined.
Forexample:
Feedcontrolrateandaccuracy,spinningspeedmeasurementrangesetpointrangeandspeedcontroltolerance,maximum“g”forcerequirement,needforpressurecontrolandaccuracyforpressure-assistedcentrifugation.
3.3.1SpeedRange:
_____to_____RPM+/-_____RPM.
3.3.2
3.4Functions
Specificoperationalrequirementsarelistedbelow.
3.4.1OperationalModes
Enteryourspecificoperationalrequirementshere.
∙Cyclesexpectedthesystemwilloperateatare…
∙Recipesthesystemwillcontainare…
∙Operatorinteractionwiththesystemwillinclude…
Thefollowingisanexample:
Thecentrifugeshallbestartedusinganoperatorinterface(OIP).Thecentrifugeshallsupportthefollowingoperationalmodes.
3.4.1.1AutomaticMode
Uponcommandfromtheoperatorinterface,themachinewillcheckthesafetyinterlocksand,ifsatisfied,executetheoperatingsequenceandfunctionsuntiltheDischargeCountersetpointhasbeensatisfied.
3.4.1.1.1Thenormalsequenceofautomaticoperationwillconsistoffilling,spinning,washing,spinning,anddischarging.
3.4.1.1.2Multiplewasheswillbepossiblewithinonewashphase(specifymaximumnumberneeded).
3.4.1.1.3Multiplewashing/spinningsets(usingdifferentwashmedia)willbepossible(specifymaximumnumberneeded).
3.4.1.1.4Allspinphasescanhavepressure-assistedcentrifugation(ifinstalled).
3.4.1.2ManualMode
Inmanualmode,allpermittedfunctionsshallbeoperatorinitiatedfromtheOIP.
3.4.1.2.1Allsafetyinterlocksshallbeenforcedduringmanualoperations.
3.4.1.2.2Theoperationpermittedinmanualmodewillincludeopeningandclosingthebowlinsert,operatingthemaindrive,openingandclosingslurry/washvalves,andtarringthecentrifugeweight.
3.4.1.3ProgramMode
Inprogrammodethesystemcanbecalibratedandrecipes,ifprovided,modified.
3.4.1.3.1ProgramModeshallbeprotectedb
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