湿热灭菌工艺验证指南.pdf

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1、湿热灭菌工艺验证指南中国医药设备工程协会2008年12月1目录一、范围........................................................................................................................3二、目的...........................................................................................

2、.............................3三、术语........................................................................................................................3四、湿热灭菌基础........................................................................................

3、................74.1湿热灭菌的机理..................................................................................................74.2影响芽孢耐热性的因素......................................................................................74.3湿热灭菌中的能量转移............

4、..........................................................................84.4湿热灭菌中微生物杀灭的数学模式..................................................................9五、灭菌法选择的基本原则...............................................................................

5、.......11六、灭菌方法的开发及选定......................................................................................126.1湿热灭菌方法选择决策树................................................................................126.2过度杀灭法......................................

6、..................................................................146.3残存概率法........................................................................................................146.4装载类型的界定...........................................................

7、....................................156.5湿热灭菌对介质的要求....................................................................................166.5.1蒸汽...........................................................................................................

8、...166.5.2压缩空气......................................................................................................176.5.3冷却水..........................................................................................................17七、湿热灭菌器的程