JETTBarrierIsolatorURS.docx

JETTBarrierIsolatorURS.docx

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JETTBarrierIsolatorURS

UserRequirementsTemplate

foraBARRIERISOLATORANDHVACSYSTEM

REVISIONHISTORY

Rev.

Date

Approval

RevisionSummary

A1

11/06/01

T.Petro

Draft

A2

01/15/02

T.Petro

IncorporatedcontentandchangesfromreviewbyJETTbreak-outgroupon11/15/01.

B1

3/1/02

MCasey

Validationreview

C1

11/20/02

MRivera

FormatReview

C2

11/26/02

T.Petro

Finalreviewofcontentandformatbyauthor

0

11/26/02

T.Petro

ApprovedforInitialRelease

TableofContents

1.0Introduction5

2.0Overview5

3.0OperationalRequirements6

3.1Capacity6

3.2ProcessRequirements6

3.3ProcessControl6

3.4Functions7

3.5DataandSecurity9

3.6Environment11

4.0Constraints14

4.1MilestonesandTimelines14

4.2EquipmentConstraints15

4.3CompatibilityandSupport15

4.4Availability17

4.5ProceduralConstraints17

4.6Maintenance19

5.0Life-Cycle19

5.1Development19

5.2Testing19

5.3Delivery20

5.4Support21

6.0Glossary22

7.0References23

8.0Approval24

ProjectNo.:

InserttheuniqueprojectnumberassociatedwiththisparticularURS.

DocumentNo.:

InserttheDocumentIdentificationNumberandRevision.

DocumentDescription:

Insertdescriptionofdocument,e.g.PURESTEAMGENERATOR,JETTExampleUserRequirementsSpecification.

Introduction

Note:

Insertyourowndescriptionandintroduction.Youmaywishtoincludeyourownrequirementsandspecificstoallowtheinexperiencedreader,contractors,andsuppliersadequateexplanationtounderstandthescopeoftheequipment.

Describewhoproducedthedocument,underwhatauthority,andforwhatpurpose.

Describethecontractualstatusofthedocument.Includeorreferenceasanattachmentthe“legal”paragraphthatcommunicatespurchasingtermsandconditionsinthissection.

Describetherelationshipofthisdocumenttootherdocuments.ThisisimportantforequipmentthatispartofanintegratedprocessorlineandwillhelptheSuppliertounderstandandaskquestionsthatmayotherwisebeoverlooked.

RefertotheEquipmentValidationPlanthatoutlinestheSupplier’sresponsibilitiesisattached.

Removeanyoptionsthatarenotapplicableforthisproject,ifotheruseswillapplylisteachseparately.

Thisistobeutilizedasaguidefortheusertoanswerthemajorityofquestionsinvolvedinspecifyingthe“what”fortheequipment.Addendumsmaybeusedtoroundouttherequirements.

Overview

TheBarrierIsolatorandHVACSystemprovidesamechanicalseparationbetweenthecontrolledroomenvironment,andtheinteriorenvironmentinwhichthepharmaceuticalproductisprocessed.Thebarrierisolatorismanufacturedinsuchamannerthatthematerialsareresistanttocorrosion,donotallowpoolingofthecleaningmaterials,andallowaccesstotheinteriorasrequiredbytheequipmentandproducts.Theenvironmentinsidethebarrierisolatoriscontrolledinamannertoallowthepharmaceuticalproducttobeprocessedinaccordancewiththepurposeandproductrequirements.

USE

Theequipmentshallbeusedprimarilyfor:

∙ContinuousProduction

∙BatchProduction

∙Other

EQUIPMENTCLASSIFICATION

Forexample:

Forprovidinganasepticenvironmentfor:

∙Liquidfillingofvialswithstoppers

∙Powderfillingofvialswithstoppers

∙Liquidfillingofampouleswithflame-off

∙Liquidfillingofcartridgeswithplugs

∙Liquidfillingofsyringes

∙Other（define）

InsertyourEquipmentClassificationshereasrequiredusingtheaboveexampleasaguide.

CLEANINGREQUIREMENTS

∙Wipedown

∙ManualWashdown

∙Clean-In-Place（CIP）

∙SpecialRequirements:

–PeraceticAcid

–EthyleneOxide

–ChlorineDioxide

–VaporizedHydrogenPeroxide

–Others

LANGUAGEREQUIREMENTS

∙English

∙Other（Specify）:

____________________

∙Bilingual?

Yes/No

OperationalRequirements

PERFORMANCEREQUIREMENTS

Capacity

Addcapacitiesanddetailsconcerningequipmentcapacityhere.Identifythetypeanddimensionsoftheequipmentthatwillfitinsideofthebarrier.

FUNCTIONS

TheBarrierIsolatorandHVACSystemisdividedintotwomainportions:

Thebarrierisolator,andtheHVACsystem.

BarrierIsolatorOperation

Thebarrierisolatorisanenclosurethatprovidesisolationbetweentheoperator/outsideenvironmentandtheinteriorofthebarrierwherethepharmaceuticalprocessingisdone.Thebarrierisolatorprovidesthefollowingfunctions:

∙Isolationbetweentheoperatorandtheprocess

∙SafetyBarriertoseparatetheoperatorfromequipmenthazards

∙Anon-corrosive,drainable,andeasilycleanedenclosure.

∙Doorstoprovideaccesstotheequipmentduringcleaningandchangeover

∙Gloveportstoallowaccesstomachineryandproductduringproduction

∙Transferportstointroducecommoditiesandequipmenttotheenvironment

∙Infeedopeningtointroducecommoditiestothesystem.

∙Exitopeningtoallowfinishedcommoditiestoexitthesystem.

BarrierIsolatorDesign

ThebarrierisolatordesignwillmeetcurrentGMPforasepticproductmanufacture,alongwithwashdownandsanitizationrequirements.

Allinteriorcornerswillhaveaminimumof__0.5”_radius.

Drainpanswillhaveaminimumof__0.5”__slopeper12”ofrun.

Horizontalsurfaceswillbeminimizedtoresistpooling.Poolingofmorethan__5ml__ofliquidisnotallowed.Pooledliquidmustnotbemorethan__2mm__deep

Drainpansshallterminateintankbottomdrainvalveswithmaterialsandfinishequivalenttotherestofthebarrierisolatorinterior.

Airdistributionfromtheplenumwilluse__dualperforatedplates__.

Theairdistributionsystemwillberemovableforcleaning.

Safetyoftheoperatorfromthemachineryorprocesseswithinthebarrierisolatormustbeensured.

Alldoorswillhavedual-redundantsafetyswitchesthatwillimmediatelystopallmachineryorprocesseswhenthedoorisopened.

Gloveportswillbeguardedwithlightcurtainstoimmediatelystopmachinery.

Allmovingmachineryexternaltothebarrierisolatorwillbefullyguardedandalarmed.

Allhightemperaturecomponentsexternaltothebarrierisolatorwillbefullyguardedandalarmed.

MaterialsandFinishoftheBarrierIsolatorwillmeetcurrentGMP’s.

1.Wallthicknessofthebarrierisolatorwillbeaminimumof__7gauge_StainlessSteel

2.Interiorsurfacesofthebarrierisolatorwillbemanufacturedfrom__316L________StainlessSteel.

3.Exteriorsurfacesofthebarrierisolatorandductworkwillbemanufacturedfrom__304or316L___StainlessSteel.

4.Interiorfinishofthebarrierisolatorwillbeof_______40_micro-inchRafinishmaximum.

5.Exteriorfinishofthebarrierisolatorwillbeof______120_micro-inchRafinishmaximum.

6.Allinteriorsurfaceswillbeelectro-polishedredundant?

Howelsedoyouget#4and#5?

.

7.Allweldswillbegroundandpolishedtotheabovefinishrequirements.

8.Airplenumsmustmeetthesamematerialsandfinishrequirementsasthebarrierisolator.

9.Thecompletedinteriorofthebarrierisolatorwillbepassivatedpriortoshipmenttothesite.

10.ComponentsattachedtotheexteriorofthebarrierisolatormustmeetcurrentGMP’sandbefinishedtoresistcorrosion.

DoorsandWindowsinthebarrierisolatorallowvisibilityandaccesstotheinterior.

1.Thewindowmaterialismanufacturedfrom__temperedsafetyglassorpolycarbonate__.

2.Thewindowsealingmaterialisextrudedfrom__siliconerubber__.

3.Windowsealsmustbedesignedtopreventpooling.

4.Doorsmusthingeopentoallowaccesstotheinterior.

5.Doorsmustberemovablewithouttools.

MouseholeOpening（s）areprovidedattheexitpointtoallowtheexitofgoodvialsandofrejectvials.

1.MouseholecoversaremanufacturedtothesamerequirementsasthebarrierIsolator.

2.Mouseholecoverpresenceistobesensedandalarmed.

Gloveportsareprovidedinthebarrierisolatortoallowoperatoraccesstotheinteriorwithoutcompromisingsterility.

1.Glovesmustbereplaceable.

2.Glovesmustbesanitizedwithoutabsorbingsterilant.

3.Gloveswillbemadefrom__fabricreinforcedPVC__.

4.Gloveswillbelocatedtoaccesscommoninterventionpoints.

5.Gloveswillbepositionedtoallowaccessbyoperatorswithinthenormalrangeofphysicalsizes.

TransferPortswillbeprovidedtoallowcomponentandproductentryintotheinteriorofthebarrierisolatorwithoutcompromisingsterility.

1.Transferportswillbelocatedatthefollowinglocations,andareofthefollowingsizes:

Location#1:

___upstreamoffiller____350mm__

Location#2:

___atstopperentry______270mm__

Location#3:

___atoutfeed__________270mm__

Location#4:

___N/A______________________

2.Transferportmanufactureis_____________________

3.Transferportsanitizationprocessis_______________

Commodity/ProductInfeedtotheinteriorofthebarrierisolatorwillbeprovidedinthedesign.

1.Vialsenterthebarrierisolatorfroma__depyrogenationtunnel__.

2.Productentersthebarrierisolatorthrougha__bulkheadfitting__.

3.Stoppersenterthebarrierisolatorthrough__transferport#2____.

4.MiscellaneousDevicessuchas:

__tools,SMAstands,hangers,platforms,instrumentation,testports,etc.___

ProductExitfromtheinteriorofthebarrierisolatorwillbeprovidedinthedesign.

5.Vialpath#1transfersvialstoa__flatbeltconveyor__.

6.Vialpath#2transfersvialstoa__22”transferdisk__.

7.Drainsinthebottomofthebarrierisolatorareprovidedat__7__pointstoallowforliquidstoberemovedduringchangeoverandsanitization.

8.Drainsmustbeclosedduringproduction.

HVACSystemOperation

TheHVACsystemcontrolstheenvironmentinsidetheisolator,andprovidesthefollowingfunctions:

∙Pressuredifferentialbetweentheinteriorandexterioroftheisolator

∙Temperaturecontrolofthei