密理博滤芯使用指南

IntrIntrIntrIntrIntroductionoductionoductionoductionoductionThischapterdescribeshowtoproperlysteamsterilizehydrophilicDuraporecartridgesandcapsules,including:■Backgroundinformationonsteamsterilization■GeneralguidelinesandStandardOperatingProcedures(SOPs)forSteamInPlace(SIP)■GeneralguidelinesandStandardOperatingProcedures(SOPs)forautoclavingCAUTION:Readthischaptercarefullysinceimpropersteamsterilizationcanoftendamagedfilters.Chapter3SteamSterilizationofHydrophilicDuraporeCartridgesandCapsules(endotoxins)isdetrimental.Themostcommonsterilizationmethodissteamunderpressure.Thismethodofsterilizationisdone,insitu(SteamInPlace)orinanautoclave.Ineithercase,moistheat(water-saturatedsteamunderpressure)isused.Themoist,hotenvironmentisaneffectivemethodofsterilizationbecausethemoistheatirreversiblydenaturesvitalenzymesthatresultinthedeathofmicroorganisms.Moisturecontributesagreatdealtotheprocess.Satu-ratedsteamat121°Csuppliesseventimesmoreavailableheatthanairatthesametemperature.Saturatedsteamhasauniquetemperatureateachpressure(forexample,15psigat121°C).SeeTable3-1fordetails.Table3–1:SaturatedSteamPressureandTemperatureSaturatedSteamPressure(psig)SaturatedSteamTemperature(°C)15121211263113546145Steamsterilizationisthemoststudiedmethodofsterilizationandispredictableandreproducibleunderde-finedoperatingconditions.Steamsterilizationprocessesarecharacterizedbymeasuringtheirmicroorganismkillefficiency.Bacillusstearothermophilussporesareusedasthechallengeorganismbecausetheyareparticu-larlyresistanttomoistheatandrepresenttheworstcasescenario.ThissectiondescribeshowtosterilizeMilliporecartridgesandcapsuleswithoutdamagingthefiltersandcom-promisingfilterintegrity.ThesteamingandautoclavecycleconditionsmentionedintheSOPsandtheguide-linesarebasedonthethermalandhydraulicstressresistanceofthefilters.Theserecommendationsarenotintendedasasubstituteforfiltersterilizationvalidation.Youmuststillperformon-sitevalidationtests.SteamRequirSteamRequirSteamRequirSteamRequirSteamRequirementsementsementsementsementsWhetheryouuseSteaminPlace(SIP)orautoclaving,youshouldsupplypuresteam.PuresteamisuncondensedWFI(WaterForInjection).Itisfreeofpyrogens,chemicals,particlesandmicroorganisms,andmustbesupplieddry,saturated,andfreeofnon-condensablegasesandcondensate.Table3–2:RecommendedFeedWaterQualityforPureSteamConductivitySilicaAmineChlorineBacterialEndotoxins*nottoexceednottoexceedbelowbelownotmorethan5microsiemens(µS)/cm1ppm**100ppm100ppm0.25EU/mL*EU=EndotoxinUnits**PPM=PartsPerMillion16HydrophilicDuraporeCartridgesandCapsulesUserGuideSteamingInPlaceofHydrSteamingInPlaceofHydrSteamingInPlaceofHydrSteamingInPlaceofHydrSteamingInPlaceofHydrophilicDuraporophilicDuraporophilicDuraporophilicDuraporophilicDuraporeCareCareCareCareCartridgestridgestridgestridgestridgesSteamingInPlace(SIP)hasthefollowingadvantageanddisadvantage:■SIPadvantage:Reducesthenumberofmanipulationsandasepticconnectionsthatmightcompromisethesterilityofthedownstreamequipment■SIPdisadvantage:Usesflowingsteam;accidentaldifferentialpressureathightemperaturethatcandamageacartridge▲▲▲▲▲WARNING:Donot,underanycircumstances,SIPcapsulefilters;seethe“AutoclavingHydrophilicDurapore”sectioninthischapterfordetails.Table3–3liststhemaximumSIPconditionsforDuraporecartridgesandthenumberofSIPcyclesthatthecar-tridgescanwithstand.Table3–3:HydrophilicDuraporeCartridges—MaximumSterilizationCycles(SIP)DeviceItemNumber(abbreviated)In-LineSteamChargedDuraporeCartridgesCCGL-----135°C,30minutes,10times,max*Durapore5CartridgesCV-L-5---135°C,30minutes,30times,max*DuraporeCartridgesCVDR--PP-,CVHL--PP-,CVGL-----,135°C,30minutes,30times,max*CVVL-----Durapore0.45µmand0.65µmCVDR--TP-,CVHL--TP-121°C,30minutes,10times,max*MultimediaCartridgesDurapore0.22µmCV03--TP3,CVSC--TP3,123°C,30minutes,6times,max*MultimediaCartridgesCV06--TP3,CVSS--TP3,CV19--TP3,CVSX--TP3MillidiskCartridgesMC-L-----135°C,60minutes,5times,max*OptisealChargedDuraporeCartridgesLCGL04--135°C,30minutes,10times,max*OptisealCartridgesw/DuraporeMembraneLAGL04---,LAVL04---,LAHL04PP-135°C,30minutes,30times,max*OptisealMultimediaCartridgesLAHL04TP121°C,30minutes,10times,max*w/DuraporeMembrane*ThesearethemaximumconditionsDuraporecartridgeshavebeenvalidatedtowithstand.Selectthetimeandtemperatureappropriatetovalidatethepropersterilizationofthedeviceandhousing.Therecommendationsinthistablearenotintendedasasubstituteforfiltersterilizationvalidation.Theuserisresponsibleforon-sitefiltersterilizationvalidationstudies.17