论文部分内容阅读
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 evaluate the safety of steam sterilization at 132 ℃ in the process of vaccine production. Methods The sterilizing effect of 132 ℃ pulsating vacuum pressure steam sterilizer in the process of vaccine production was verified and evaluated by physical, chemical and biological monitoring methods. Results pulsating vacuum pressure steam sterilizer by BD test to confirm the performance of the sterilizer qualified, in the production of vaccines used in the production of bottles, rubber stopper, cap bolt, silicone tube, sampling glass straw and other items to full load, set Sterilization temperature 132 ℃, the role of sterilization process for 8 min. After the heat penetration test, microbiological challenge test and sterilization test of sterilized items, the sterilization methods all meet the requirements of sterilization assurance and current GMP. Conclusion The results of sterilization proved that the use of 132 ℃ pulsating vacuum pressure steam sterilizer for sterilizing the equipment in the process of vaccine production completely meets the standard requirements.