Designation:E2614−15StandardGuideforEvaluationofCleanroomDisinfectants1ThisstandardisissuedunderthefixeddesignationE2614;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguideidentifiesimportantfactorstoconsiderwhenselectingadisinfectantforuseinacleanroomorsimilarcontrolledenvironmentandrecommendstestmethodssuitableforevaluatingdisinfectants.Theproperselectionofdisinfect-ingagentcombinedwithqualificationtestingisakeyelementofasuccessfuldisinfectionprogram.RegulatoryguidancesuchasUnitedStatesPharmacopoeiaChapter<1072>,“Disinfec-tantsandAntiseptics”andtheFDAGuidanceforIndustry,“SterileDrugProductsProducedbyAsepticProcessing–Cur-rentGoodManufacturingPractice”addressthenecessityofdisinfectanteffectivenesstestingbutdonotclearlydefineacceptabletestmethods.1.2Anunderstandingofmicrobiologyandmicrobiologicaltechniquesisessential.Knowledgeinthefollowingareasisrecommended:microorganisms,antimicrobialproducts(disinfectants,sporicides,anddecontaminationagents),thechemistryofdisinfection,mechanismofactivityofdisinfec-tantsoncells,applicationprocedures,cleanroomsurfaces,andenvironmentalconditionswithinacleanroom.Thisinforma-tionisavailableinseveralpublishedtextslistedinthebibliography.1.3Thetheoreticalbasisfordisinfectantactivityisnotaddressedinthisguide.Anunderstandingoftheeffectofdisinfectantconcentrationonmicrobialreduction(concentra-tionexponent)andkineticsisdesirableindeterminingtheuse-dilutionofdifferentdisinfectantsandinusingdilutiontoneutralizeadisinfectantforefficacytesting.USPchapter<1072>providesfurtherinformationonthistopic.1.4Thisguideiswrittenforthecleanroomenvironment,althoughmanyoftheprinciplesoutlinedinthisstandardareapplicabletomanufacturingandprocessingenvironmentsoutsideofthecleanroom.1.5Evaluationofdisinfectantsforbiofilmcontrolisout...
