ASTM E2614-2008 洁净室消毒剂评估的标准指南

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【英文标准名称】:StandardGuideforEvaluationofCleanroomDisinfectants
【原文标准名称】:洁净室消毒剂评估的标准指南
【标准号】:ASTME2614-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:E35.15
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:carriertests;cleanroom;disinfectant;disinfectantqualification;efficacy;insitutesting;suspensiontests
【摘要】:Requirementsforasepticprocessingareasincludereadilycleanablefloors,walls,andceilingsthathavesmooth,non-poroussurfaces;particulate,temperature,andhumiditycontrols;andcleaninganddisinfectingprocedurestoproduceandmaintainasepticconditions.Theseconditionscombinedwithcarefulandthoroughevaluationofthechemicalagentsusedforthecleaninganddisinfectionprogramshouldleadtoachievingthespecifiedcleanlinessstandardsandcontrolofmicrobialcontaminationofproducts.Inrecentyears,theuseofdisinfectantsinpharmaceutical,biotechnology,medicaldevicefacilities,andassociatedcontrolledenvironmentshasbeenthesubjectofscrutinybyregulatoryagencies.AneffectivecleaninganddisinfectionprograminasepticprocessingareasofaGoodManufacturingPractice(GMP)facilityiscriticaltoassurethequalityoftheproducts.Manufacturersarebeingheldtoahighstandardwhenitcomestoproductsterilityandregulatoryagenciesareincreasinglyaskingforvalidationdatatosupportsanitizationanddisinfectionprocedures.Regulatoryauthoritiesnowexpectevidenceoftheefficacyofdisinfectionagentsagainstenvironmentalisolates.TheFDAGuidelineforAsepticProcessingstates,x201C;thesuitability,efficacy,andlimitationsofdisinfectingagentsandproceduresshouldbeassessed.Theeffectivenessofthesedisinfectantsandproceduresshouldbemeasuredbytheirabilitytoensurethatpotentialcontaminantsareadequatelyremovedfromsurfaces.x201D;6Basicknowledgeregardingtheeffectivenessofdifferentchemicalagentsagainstvegetativebacteria,fungi,andsporeswillaidinselectingchemicalagents.Agoodunderstandingoftestmethodsusedtoassessdisinfectanteffectivenessisimportant.Mostmethodsareadaptableallowingtheusertocustomizethemethodstotheirspecificrequirements.1.1Thisguideidentifiesimportantfactorstoconsiderwhenselectingadisinfectantforuseinacleanroomorsimilarcontrolledenvironmentandrecommendstestmethodssuitableforevaluatingdisinfectants.Theproperselectionofdisinfectingagentscombinedwithin-housequalificationtestingisakeyelementtoasuccessfuldisinfectionprogram.Recentpublicationsofregulatoryguidance/standardssuchasChapterx003C;1072>,x201C;DisinfectantsandAntisepticsx201D;intheUnitedStatesPharmacopoeiaaddresstheissueofdisinfectanttestingbutthereisverylittlepublishedguidanceonwhatcriteriaandtestmethodsshouldbeusedforselectionandefficacytestingofdisinfectantsthatwillbeusedincleanroomsandcontrolledenvironments.1.2Anunderstandingofmicrobiologyandmicrobiologicaltechniquesisessential.Knowledgeinthefollowingareasisrecommended:microorganisms,antimicrobialproducts(disinfectants,sporicides,anddecontaminationagents),andthechemistryofdisinfection,mechanismofactivityofdisinfectantsoncells,applicationprocedures,cleanroomsurfaces,andenvironmentalconditionswithinacleanroom.Thisinformationisavailableinseveralpublishedtextslistedinthebibliography.1.3Thetheoreticalbasisfordisinfectantactivityisnotaddressedinthisguide.Anunderstandingoftheeffectofdisinfectantconcentrationonmicrobialreduction(concentrationexponent)andkineticsisdesirableindeterminingtheuse-dilutionofdifferentdisinfectantsandinusingdilutiontoneutralizeadisinfectantforefficacytesting.USPchapterx003C;1072>providesfurtherinformationonthistopic.1.4Althoughtheinformationinthisguideis......
【中国标准分类号】:C47
【国际标准分类号】:13_040_35
【页数】:5P.;A4
【正文语种】:英语