PDA 湿热灭菌柜(中英).pdf

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1、Content目录1.0Introduction引言............................................................................................................41.1Purpose/Scope目的/范围.........................................................................................52.0Glos

2、saryofTerms术语................................................................................................83.0SterilizationProcesses灭菌过程..............................................................................193.1SaturatedSteamProcesses饱和蒸汽程序..

3、......................................................193.1.1GravityDisplacementProcess重力置换程序............................................203.1.2Pre-VacuumProcess预真空程序.................................................................223.2AirOverpressurePr

4、ocesses空气加压程序........................................................223.2.1SteamAirMixtureProcessandSuperheatedWaterProcess蒸汽空气混合气体工艺&过热水工艺..........................................................................................233.3DecontaminationPro

5、cesses净化程序................................................................243.4GMPandNon-GMPSterilizers/GMP和非GMP灭菌器...................................264.0ComprehensiveSterilizerSystemDesign灭菌器系统全面设计........................294.1UserRequirementsSpecifica

6、tions用户需求....................................................314.1.1EquipmentLocation,Installation,andMaintenanceAccessConsiderations设备位置安装、维护通道的要求...................................................314.1.2AssessingProcessRequirements评估工艺要求..............

7、........................354.2SystemControl系统控制........................................................................................374.3FunctionalRequirementsSpecifications功能需求........................................394.4DetailedDesignSpecification详细

8、设计............................................................405.0EquipmentVerification&Qualification设备验证或确认.....................................425.1Commissioning试车...............................................................