除菌过滤器验证(二):除菌效率验证  

Validation of sterilizing grade filters(Ⅱ):sterilization efficiency

作　　者：谢婷 唐燕 董巍 洪海燕 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13期1161-1164,共4页Chinese Journal of New Drugs

摘　　要：目前,过滤除菌技术已广泛应用于制药领域。根据药品的特性选择合适的除菌级过滤器,并结合特定的工艺条件对其除菌效率进行充分的验证是保证药品达到相应无菌保证水平的关键和必要条件。本文从过滤除菌工艺的有效性和安全性角度出发,对验证除菌级过滤器除菌效率的3个阶段、验证的必要性、工艺特定验证的原理和方法、最差条件的选择等进行了综述。Sterile filtration has been widely applied in the pharmaceutical industry.Choosing appropriate sterilizing grade filter according to the characteristics of drugs,and validating its bacteria retention efficiency sufficiently under defined process conditions are the key point and necessary condition to ensure the drugs achieve relevant aseptic guarantee level.In this paper,we overviewed the three stages of validation on the sterilizing grade filter and sterile filtration process,the necessity of validation,principle and method in process-specific validation as well as worst-case conditions from the standpoints of efficacy and safety in sterile filtration process.

关 键 词：验证 除菌级过滤器 除菌效率 细菌挑战 最差条件 

分 类 号：R95[医药卫生—药学]