湿热灭菌工艺验证指南
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
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