PDA-湿热灭菌柜(中英).pdf

Content 目录 1.0 Introduction 引言 ............................................................................................................ 4 1.1 Purpose/Scope 目的/范围 ......................................................................................... 5 2.0 Glossary of Terms 术语 ................................................................................................ 8 3.0 Sterilization Processes 灭菌过程 .............................................................................. 19 3.1 Saturated Steam Processes 饱和蒸汽程序 ........................................................ 19 3.1.1 Gravity Displacement Process 重力置换程序 ............................................ 20 3.1.2 Pre-Vacuum Process 预真空程序 ................................................................. 22 3.2 Air Overpressure Processes 空气加压程序 ........................................................ 22 3.2.1 Steam Air Mixture Process and Superheated Water Process 蒸汽空气混 合气体工艺 过热水工艺 .......................................................................................... 23 3.3 Decontamination Processes 净化程序 ................................................................ 24 3.4 GMP and Non-GMP Sterilizers/GMP 和非 GMP 灭菌器 ................................... 26 4.0 Comprehensive Sterilizer System Design 灭菌器系统全面设计 ........................ 29 4.1 User Requirements Specifications 用户需求 .................................................... 31 4.1.1 Equipment Location, Installation, and Maintenance Access Considerations 设备位置安装、维护通道的要求 ................................................... 31 4.1.2 Assessing Process Requirements 评估工艺要求 ...................................... 35 4.2 System Control 系统控制 ........................................................................................ 37 4.3 Functional Requirements Specifications 功能需求 ........................................ 39 4.4 Detailed Design S