132℃灭菌法在疫苗生产中的灭菌效果验证  

The sterilization effect validation of 132℃ steam sterilization in vaccine production

作　　者：王舰兵 李铎 徐康 纪权 李越 刘延威 卢成森 王丽华 WANG Jian - bing LI Duo XU Kang JI Quan LI Yue LIU Yan- wei LU Cheng - sen Wang Li - hua(Changchun Qijian Biological Products Limited Company, Changchun Jilin 130012, China)

机构地区：[1]长春祈健生物制品有限公司,吉林长春130012

出　　处：《中国消毒学杂志》2017年第5期419-421,共3页Chinese Journal of Disinfection

摘　　要：目的评价132℃压力蒸汽灭菌法在疫苗生产过程中灭菌效果验证的安全性。方法通过物理、化学和生物监测方法,对132℃脉动真空压力蒸汽灭菌器在疫苗生产过程中的灭菌效果进行验证并作出评价。结果脉动真空压力蒸汽灭菌器经B-D试验确认灭菌器性能合格后,在装入疫苗生产中常用的培养瓶、橡胶栓、翻帽栓、硅胶管、取样玻璃吸管等物品达到满载,设定灭菌温度132℃,作用8 min灭菌程序。经热穿透试验、微生物挑战试验以及灭菌后物品的无菌试验等验证方法,灭菌效果全部符合灭菌保证水平和现行GMP的要求。结论经灭菌效果验证,132℃脉动真空压力蒸汽灭菌器用于疫苗生产过程中器材灭菌完全达到规范的要求。Objective To verify the safety of sterilization effects of 132 ℃ steam sterilization with pressure during the pro- duction process of vaccine. Methods The physical method, chemical method and biological monitoring method were used to verify and evaluate the sterilization effects of the 132℃ pulsation vacuum pressure steam sterilizer during the production process of vaccine. Results The sterilization performance of pulsation vacuum pressure steam sterilizer should be qualified when confirmed by the B - D experiment. Then the commonly used appliance like culture bottle, rubber plug, double cap bolts, silicone tube and sampling glass pipe were set into the sterilizer until it was fully loaded. The temperature of steriliza- tion was 132 ℃ and the sterilization time was 8 min. The heat penetration test, microbial challenge test, sterility test of steri- lized appliance and other test proved that the sterilization effect was entirely accord with the requirement of sterilization as- surance level and current GMP. Conclusion The 132 ℃ pulsation vacuum pressure steam sterilizer can reach the require- ment of sterilization standard during the production process of vaccine after the sterilization effect verification.

关 键 词：疫苗生产 脉动真空灭菌器 灭菌效果 验证 

分 类 号：R187.5[医药卫生—流行病学]