微生物检验圣经
-USP39微生物相关条目汇总
51AntimicrobialEffectivenessTest抑菌效力测试
55BiologicalIndicators—ResistancePerformanceTests
生物指示剂-耐受力测试
61MicrobialExaminationofNonsterileProducts:MicrobialEnumerationTests
非无菌产品微生物检查：微生物计数
62MicrobiologicalExaminationofNon-SterileProducts:AbsenceofSpecifiedMicroorganisms
非无菌产品微生物检查：控制菌
63MycoplasmaTests支原体检查
71SterilityTests无菌检测
85BacteriaEndotoxinTest细菌内毒素检测
PyrogenTest热原检测
AlternativeSamplingMethodsforNonsterileInhaledandNasalProducts
非无菌吸入剂和鼻用制剂的替代取样方法
DisinfectantsandAntiseptics
消毒剂和杀菌剂
MicrobiologicalExaminationofNonsterileProducts：AcceptanceCriteriaForPharmaceuticalPreparationsandsubstancesforPharmaceuticalUse非无菌产品微生物检查：药用制剂和药用原料的限度标准
ApplicationofWaterActivity水活度应用
MicrobialIdentification，CharacterizationandStrainTyping微生物鉴定、特性确认和菌株分型
Bio-burdenControlofNon-sterileDrugSubstancesandProducts
非无菌药物和原料的生物负荷控制
MicrobiologicalControlandMonitoringofAsepticProcessingEnvironments
无菌生产工艺环境的微生物控制和监测
MicrobiologicalBestLaboratoryPractices
微生物实验室良好作业规范
Sterileproductpackaging–Integrityevaluation无菌产品包装-完整性评估
SterilityTesting-ValidationofIsolatorSystems无菌测试-隔离器的验证
SterilizationandSterilityAssuranceofCompendialArticles无菌和无菌保证
TerminallySterilizedPharmaceuticalProducts-Parametricrelease终端灭菌产品-参数放行
ValidationofAlternativeMicrobiologicalMethods微生物替代方法的验证
ValidationofMicrobialRecoveryfromPharmaceuticalArticles微生物回收率的验证
Depyrogen除热原
Sterilization灭菌
?.1SteamSterilizationbyDirectContact
直接接触的蒸汽灭菌
?.2MoistHeatSterilizationofAqueousLiquids
液体的湿热灭菌
?.3MonitoringofBioburden微生物负载的监控
?.4SterilizingFiltrationofLiquids
液体的过滤除菌
?.5BiologicalIndicatorsforSterilization
灭菌的生物指示剂
?.6LiquidPhaseSterilization液相灭菌
?.7GaseousSterilization气体灭菌
?.8DryHeatSterilization干热灭菌
?.9PhysicochemicalIntegratorsandIndicatorsforSterilization灭菌的理化监测器和指示剂
?.10RadiationSterilization辐射灭菌
?.11VaporPhaseSterilization汽相灭菌
?.12NewSterilizationMethods新方法
?.13Sterilization-in-Place在线灭菌
WaterforPharmaceuticalUse制药用水
MicrobiologicalProceduresforAbsenceofSpecifiedMicroorganisms-NutritionalandDietarySupplements
控制菌检查法-营养和食品补充剂
MicrobiologicalAttributesofNonsterileNutritionalDietarySupplements
非无菌营养和食品补充剂的微生物评估
以英文为准
接地气的医药从业者分享
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