PDA 湿热灭菌柜(中英)

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

2、......................................................................................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.................................................................223.2AirOverpressureProcesses空气加压程序........................................................

4、223.2.1SteamAirMixtureProcessandSuperheatedWaterProcess蒸汽空气混合气体工艺&过热水工艺..........................................................................................233.3DecontaminationProcesses净化程序................................................................243.4GMPandNon-GMP

5、Sterilizers/GMP和非GMP灭菌器...................................264.0ComprehensiveSterilizerSystemDesign灭菌器系统全面设计........................294.1UserRequirementsSpecifications用户需求....................................................314.1.1EquipmentLocation,Installation,andMaintenanceAc

6、cessConsiderations设备位置安装、维护通道的要求...................................................314.1.2AssessingProcessRequirements评估工艺要求......................................354.2SystemControl系统控制........................................................................................374.

7、3FunctionalRequirementsSpecifications功能需求........................................394.4DetailedDesignSpecification详细设计............................................................405.0EquipmentVerification&Qualification设备验证或确认.....................................425.1Commission

8、ing试车...............................................................