欢迎来到天天文库
浏览记录
ID:40353937
大小:2.77 MB
页数:47页
时间:2019-07-31
《9 - Validation of Steam Sterilization for Filtration Equipment》由会员上传分享,免费在线阅读,更多相关内容在学术论文-天天文库。
1、ValidationofSteamSterilizationforFiltrationEquipmentModule9CopyrightMerckMillipore2011.1OverviewExamplesofregulationsSteamandautoclaveequipmentengineeringguidelinesThermalqualificationtheoryandpracticeBiologicalqualificationtheoryandpracticeValidationpracticesforfil
2、tersterilizationbyautoclavingandSIPCopyrightMerckMillipore2011.2USRegulatoryRequirement1–1GuidanceforIndustryfortheSubmissionDocumentationforSterilizationProcessValidationinApplicationsforHumanandVeterinaryDrugProducts,Nov1994A.DescriptionoftheProcessandProductB.The
3、rmalQualificationoftheCycle1.TheDrugProductandContainer-Closure1.HeatDistributionandPenetrationStudiesSystem2.ThermalMonitors2.TheSterilizationProcess3.TheEffectsofLoadingonThermalInput3.TheAutoclaveProcessandPerformance4.InformationIncludedintheBatchRecordSpecifica
4、tions4.AutoclaveLoadingPatternsC.MicrobiologicalEfficacyoftheCycle5.MethodsandControlstoMonitor1.IdentificationandCharacterizationofBioburdenProductionCyclesOrganisms6.RequalificationofProductionAutoclaves2.SpecificationsforBioburden7.Reprocessing3.Identification,Re
5、sistance,andStabilityofBiologicalIndicators4.TheResistanceoftheBiologicalIndicatorRelativetoThatofBioburden5.MicrobiologicalChallengeStudiesCopyrightMerckMillipore2011.3USRegulatoryRequirements–SterileDrugProductsProducedbyAsepticProcessing—CurrentGoodManufacturingP
6、ractice,Sept2004“Heatpenetrationstudiesshouldbeperformedusingtheestablishedsterilizerloads.”“Theplacementofbiologicalindicatorsatnumerouspositionsintheload,includingthemostdifficulttosterilizeplaces,isadirectmeansofconfirmingtheefficacyofanysterilizationprocedure.
7、““Ingeneral,thebiologicalindicatorshouldbeplacedadjacenttothetemperaturesensorsoastoassessthecorrelationbetweenmicrobiallethalityandpredictedlethalitybasedonthermalinput.”“specialattentionshouldbegiventothesterilizationoffilters,fillingmanifolds,andpumps”“Asteril
8、ityassurancelevelof10-6orbettershouldbedemonstratedforasterilizationprocess.”“filterinstallationsinpipingcancauseasubstantialpressurediff
此文档下载收益归作者所有