除菌过滤器微生物截留的试验分析

Microbial retention efficacy analysis of filter sterilization

目的:探讨非最终灭菌注射剂生产过程中除菌过滤器对微生物的截留效果,确认过滤除菌工艺的有效性与安全性。方法:采用孔径为0.22μm除菌级聚醚砜滤芯,以直径在0.3～0.4μm的缺陷假单胞菌为生物指示剂,将菌液用滤芯过滤,计算被过滤液体过滤前的微生物数量与过滤后的微生物数量比的常用对数值(LRV)。结果:菌液过滤前后微生物数量比的常用对数值LRV大于7。结论:滤芯每平方厘米有效过滤面积符合中国药典2005年版2部附录ⅩⅦ灭菌法的规定,确认除菌过滤工艺在注射剂生产过程中的有效性与安全性。

Objective： To investigate the microbial retention efficacy of filter sterilization in order to evaluate safety and potency of the sterilization technique. Methods： Pseudomonas diminuta at diameter of 0.3~0.4 μm was used as bio-indicator, to be filtered through a PESU made filter sterilization at pore size of 0.22 μm, then calculate the log reduction value （LRV）. Results： The calculated LRV was greater than 7. Conclusion： The effective filter space per square centimeter met the standard of the sterilization law which is written in the appendix X Ⅷ of Chinese Pharmacopoeia published in 2005 （2nd edition） , and the result confirms the effectiveness and safety of the sterilization filtration technology used in the lucentis production.