湿热灭菌工艺验证指南

目录

一、范围........................................................................................................................3

二、目的........................................................................................................................3

三、术语........................................................................................................................3

四、湿热灭菌基础........................................................................................................7

4.1湿热灭菌的机理..................................................................................................7

4.2影响芽孢耐热性的因素......................................................................................7

4.3湿热灭菌中的能量转移......................................................................................8

4.4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......................................................................................11

六、灭菌方法的开发及选定......................................................................................12

6.1湿热灭菌方法选择决策树................................................................................12

6.2过度杀灭法........................................................................................................14

6.3残存概率法........................................................................................................14

6.4 装载类型的界定...............................................................................................15

6.5湿热灭菌对介质的要求....................................................................................16

6.5.1蒸汽..............................................................................................................16

6.5.2压缩空气......................................................................................................17

6.5.3冷却水..........................................................................................................17

七、湿热灭菌器的程序控制和记录仪表.............................................................17

7.1WHOGMP的原则要求.....................................................................................17

7.2 技术性要求.......................................................................................................18

7.3对验证用测试仪器的要求................................................................................18

八、几种常用的湿热灭菌法..................................................................................19

8.1液体注射剂产品的灭菌....................................................................................19

8.2 多孔/固体物品的灭菌......................................................................................22

九、灭菌工艺的验证及验证文件..........................................................................24

9.1灭菌工艺验证的步骤........................................................................................24

9.2验证文件............................................................................................................26

9.3水喷淋式灭菌器验证方案示例........................................................................27

十、附表..................................................................................................................32

十一、附件-蒸汽质量测试法.................................................................................35 

不凝性气体的测试..................................................................................................35

过热值测试..............................................................................................................37

干燥值测试..............................................................................................................37

十二、参考文献.......................................................................................................41

在线预览：湿热灭菌工艺验证指南

********************************************

湿热灭菌工艺验证指南