原料药和预灌封注射器的气体灭菌解决方案（环氧乙烷和二氧化氮） ----- 袁桂英.pdf

1、Gaseous sterilization solutions for Drug substances and prefilled Devices(Ethylene Oxide and Nitrogen Dioxide)原料药和预灌封注射器的气体灭菌解决方案（环氧乙烷和二氧化氮）Jessica YuanAUG 2024CONFIDENTIAL1Safeguarding Global HealthExpert Lab Testing and ConsultingReliable Global Supply of Cobalt-60Comprehensive Sterilization Servi

2、cesSafeguarding Global Health with every test we complete.Safeguarding Global Health with every Cobalt-60 source we supply.Safeguarding Global Health with every product we sterilize.Expert Lab Testing&Advisory ServicesReliable Global Supply of Cobalt-60Comprehensive Sterilization Solutions&Expert Ad

3、visory ServicesIntroduction of Sotera HealthCONFIDENTIAL2袁桂英袁桂英(Jessica Yuan)(Jessica Yuan)职位：工厂总经理工作单位：施洁医疗技术(上海)有限公司工作经历：2014.10现在 施洁医疗技术(上海)有限公司 工厂总经理2013.092014.09 施洁中国区质量经理2009.122013.09 施洁医疗技术(上海)有限公司 质量经理中国医疗器械行业协会医疗器械包装专委会技术工作组 灭菌组组长IRCA认可 ISO9001 主任审核员联系电话：18616605050CONFIDENTIALThere are t

4、wo(2)strategies to produce a sterile drug product:两种获得无菌药品的策略Sterilization终端灭菌Aseptic Assembly无菌组装Introduction 介绍CONFIDENTIAL4Exposure to a physical or chemical sterilizing agent for a predetermined extent of treatmentMaintain sterility of a product that is assembled from components,each of which ha

5、s been previously sterilizedAseptic Assembly无菌组装无菌组装Terminal Sterilization终端灭菌终端灭菌SterileSterilizedIntroduction 介绍介绍CONFIDENTIALIntroduction 介绍Physical物理的Chemical 化学的HeatIonizing RadiationGammaE-BeamX-RayDryMoistGasVaporOxidizing ChemistryAlkylatingChemistryNitrogen Dioxide Chlorine Dioxide Ethylene

6、 Oxide Hydrogen PeroxideSterilization Modalities 灭菌方式CONFIDENTIALProvide Optimal Sterilization Solutions 提供优化的灭菌解决方案6Electron Beam and X-RayGamma RadiationEthylene Oxide Nitrogen Dioxide and Vaporized Hydrogen Peroxide Plasma OxygenSupercritical Carbon DioxideEOscCO2NO2&VH2O2E-BEAM&X-RAYRADPLASMA O2