除菌过滤器验证(四):兼容性验证  

Validation of sterilizing grade filters(IV):compatibility

作　　者：唐燕 洪海燕 谢婷 董巍 蔡清波 黄晓龙[2] 

机构地区：[1]颇尔中国生命科学部,上海201203 [2]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2011年第18期1735-1736,共2页Chinese Journal of New Drugs

摘　　要：兼容性验证是过滤器工艺验证项目之一,以证实工艺及工艺条件对过滤器的特定性能没有产生负面影响。文中介绍了兼容性的概念、兼容性验证的目的和除菌过滤器兼容性验证实验的方法,同时介绍了重复使用过滤器的兼容性验证和同系列药品在兼容性验证中的分组原则。Compatibility is one of the projects in filtration process validation, which provides a proof that the filter performance is not affected by the fluid and conditions in the process. This article introduced compatibility conception, the purpose of compatibility validation and the compatibility method of sterilizing filter, and also discussed compatibility validation for re-use of filters and grouping principle for products in compatibility validation.

关 键 词：兼容性 验证 除菌 过滤 重复使用 

分 类 号：R95[医药卫生—药学]