本文格式为Word版，下载可任意编辑美国湿热灭菌的验证PDA Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control Technical Report N01 (Revised 2022) Supplement Vol. 61, N0 S-1 c 2022 by PDA P D A Parenteral Drug Association 湿热灭菌的验证： 灭菌程序的设计，开发，确认和日常监控 2022年增补，第一卷 N0.S-1 美国注射剂协会 制药科学及技术杂志 编写委员：中国医药设备工程协会技术委员会 发行单位：中国医药设备工程协会 1 湿热灭菌程序的验证：灭菌程序的设计、开发、确认以及日常监控 目次 1.0引言............................................................................................................................................. 4 1.1范围 ...................................................................................................................................... 4 2.0术语............................................................................................................................................. 5 3.0灭菌科学 ................................................................................................................................... 11 3.1 灭菌模式 ........................................................................................................................... 12 3.1.1 耐热参数（DT）..................................................................................................... 13 3.1.2 温度系数（z值） .................................................................................................. 15 3.1.3 灭菌率（Lethal Rate）和累计杀灭时间（lethality，F）.................................... 16 3.2灭菌指示剂 ........................................................................................................................ 20 3.2.1 生物指示剂（BIs）................................................................................................ 20 3.2.2 化学监测器 ............................................................................................................. 21 3.3热力学和蒸汽质量 ............................................................................................................ 22 3.3.1 温度和热量 ............................................................................................................. 22 3.3.2 蒸汽 ......................................................................................................................... 28 3.3.3 纯蒸汽质量的测试 ................................................................................................. 28 4.0 灭菌程序的开发 ...................................................................................................................... 30 4.1 设计方法 ........................................................................................................................... 30 4.1.1 灭菌程序设计方法中残存曲线的应用 ................................................................. 31 4.2 装载类型 ........................................................................................................................... 34 4.2.1 多孔/坚硬装载的定义 ............................................................................................ 34 4.2.2 液体装载的定义 ..................................................................................................... 34 4.3 灭菌程序 ........................................................................................................................... 35 4.3.1 饱和蒸汽灭菌程序 ................................................................................................. 35 4.3.2 空气加压程序 ......................................................................................................... 38 4.4 灭菌程序的开发 ............................................................................................................... 40 4.4.1 多孔/坚硬装载灭菌程序的开发 ............................................................................ 40 4.4.2 液体装载灭菌程序的建立 ..................................................................................... 45 4.5 稳定性研究 ....................................................................................................................... 48 5.0 灭菌程序的性能确认 .............................................................................................................. 48 5.1 物理确认 ........................................................................................................................... 49 5.1.1 热分布 ..................................................................................................................... 49 5.1.2 热穿透 ..................................................................................................................... 49 5.2 生物指示剂确认 ............................................................................................................... 50 5.2.1 生物指示剂挑战系统 ............................................................................................. 50 5.2.2 生物指示剂的使用和放置 ..................................................................................... 51 5.3 灭菌程序性能确认合格标准 ....................................。