1208USpSTERILITY TESTINGVALIDATION OF ISOLATOR SYSTEMS.docx
- 文档编号:2397200
- 上传时间:2022-10-29
- 格式:DOCX
- 页数:8
- 大小:22.55KB
1208USpSTERILITY TESTINGVALIDATION OF ISOLATOR SYSTEMS.docx
《1208USpSTERILITY TESTINGVALIDATION OF ISOLATOR SYSTEMS.docx》由会员分享,可在线阅读,更多相关《1208USpSTERILITY TESTINGVALIDATION OF ISOLATOR SYSTEMS.docx(8页珍藏版)》请在冰豆网上搜索。
1208USpSTERILITYTESTINGVALIDATIONOFISOLATORSYSTEMS
1208STERILITYTESTING—VALIDATIONOFISOLATORSYSTEMS
Thischapterprovidesguidelinesforthevalidationofisolatorsystemsforuseinsterilitytestingofcompendialarticles加工配制药物.[note—Inthecontextofthischapter,“decontaminated”净化referstoanitemorsurfacethathasbeensubjectedtoaprocessthateliminates消除viable存活的bioburden微生物量.]
Isolators—devicesthatcreatecontrolledenvironmentsinwhichtoconductPharmacopeialsterilitytests—havebeenusedsincethemid-1980s.AnisolatorissuppliedwithairthroughaHEPAorbetterairfilterandisabletobereproduciblydecontaminated.Closedisolators,whicharesystemswithnodirectopeningtotheexternalenvironment,arenormallyusedforsterilitytesting,althoughopenisolatorswhichallowtheegress出口,外出ofmaterialsthroughadefinedopeningthatprecludes排除theentry进入ofcontaminationbymeansofairoverpressure过压maybeused.Closedisolatorsuseonlydecontaminatedinterfacesorarapid-transferportforthetransferofmaterials.Isolatorsareconstructedofflexibleplastics(suchaspolyvinylchloride),rigidplastics,glass,orstainlesssteel.
Isolatorsystemsprotectthetestarticleandsuppliesfromcontaminationduringhandlingbyessentiallyeliminatingdirectcontactbetweentheanalystandthetestarticles.Alltransfersofmaterialintoandoutoftheisolatorareaccomplishedinanaseptic无菌的,防腐剂fashionwhilemaintainingcompleteenvironmentalseparation.Asepticmanipulationswithintheisolatoraremadewithhalf-suits,whichareflexiblecomponentsoftheisolatorwallthatallowtheoperatorafullrangeofmotionwithintheisolator,orbyglovesandsleeves.Operatorsarenotrequiredtowearspecialclean-roomclothingforconductingsterilitytestswithinisolators;standardlaboratoryclothingisadequate,althoughapairofsterileglovesisfrequentlywornundertheisolatorglovesasanaddedprecautionagainstcontaminationenteringtheisolatorenclosureandforhygienepurposes.Theinterioroftheisolatoristreatedwithsporicidalchemicalsthatresultintheeliminationofallviablebioburdenonexposedsurfaces.
ISOLATORDESIGNANDCONSTRUCTION构造
AirHandlingSystems
Anisolatorusedforsterilitytestingisequippedwithmicrobialretentivefilters(HEPAfiltersorbetterarerequired).Atrest,theisolatormeetstheparticulateair-qualityrequirementsforanISOClass5areaasdefinedinISO14644-1through-3*(seeMicrobiologicalEvaluationofCleanRoomsandOtherControlledEnvironments1116).However,theisolatorneednotmeetClass5conditionsduringanoperationthatmaygenerateparticulates,andnorequirementsforairvelocity速率,高速orairexchangerateexist.Theisolatorshouldbesealed密封wellenoughduringdecontaminationthatthedissemination传播ofsporicidal杀孢子vaporsorgasesintothesurroundingenvironmentiskepttoappropriatelylowlevels.Whendirectopeningstotheoutsideenvironmentexist,constantairoverpressureconditionsmaintainsterileconditionswithintheisolator.Ingeneral,bothopenandclosedisolatorsaremaintainedatpositivepressurerelativetothesurroundingenvironment,andoverpressuresof20Paormorearetypical.Theusershouldneverexceedthemaximumpressurerecommendedbytheisolatormanufacturer.Airflowwithinisolatorsusedforsterilitytestingiseitherunidirectionalorturbulent.
TransferPortsandDoors
Isolatorsmaybeattachedtoa“pass-through”decontaminatorortransferisolatortoenablethedirecttransferofsterilemedia,steriledilutionfluids,andsterilesuppliesfromthedecontaminatorintotheisolatorsystem.Rapidtransferports(RTPs)enabletwoisolators,i.e.,theworkstationandtransferisolator,tobeconnectedtooneanother,sothatsuppliescanbemovedasepticallyfromoneisolatortoanother.AsepticconnectionsbetweentwoisolatorsoranisolatorandanRTP-equippedcontainercanbemadeinunclassifiedenvironmentsusingRTPs.ThenonsterilesurfacesoftheRTPareconnectedusinglockingringsorflanges.Acompressedgasketassemblyprovidesanairtightseal,therebypreventingtheingressofmicroorganisms.
WhenthetwoRTPflangesarelinkedtoformanairtightpassage,anarrowbandofgasketremainsthatcouldharbormicrobialcontamination.Thisexposedgasketshouldberoutinelydisinfectedimmediatelyaftertheconnectionismade,andbeforematerialsaretransferredthroughtheRTP.Goodaseptictechniqueisusedwhentransferringmaterialsandcareistakennottotouchthegasketwiththematerialsbeingtransferredorwiththeglovedhands.
PreventivemaintenanceandlubricationofthegasketassembliesontheflangesisperformedaccordingtotheRTPmanufacturer'srecommendations.TheRTPgasketsarechangedattherecommendedfrequencyandperiodicallycheckedfordamage,becausecutortorngasketscann
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- 1208USpSTERILITY TESTINGVALIDATION OF ISOLATOR SYSTEMS 1208 USpSTERILITY
链接地址:https://www.bdocx.com/doc/2397200.html