药品无菌检测中培养基灭菌控温的方法验证

用湿热灭菌方法对培养基灭菌时,加热的温度对微生物死亡和营养成分的破坏均有作用,本文通过对灭菌设备进行改造,采用仪器控温探头和培养基控温探头同时插入培养基中,对培养基灭菌温度进行控制。从而确保培养基灭菌温度的稳定性,有效性。该法与传统的控温方式比较,热穿透试验更好,培养基能达到灭菌要求的F0值。

Method validation of mediume sterilization temperature control for sterility test

The high temperature will not only lead to the microbial death but also destroy the nutrients when culture medium was sterilized by moist heat sterillization.Here,the sterilization equipment was transformed to address the undesirable problem.The instrument temperature probe and the culture medium temperature probe were inserted into the medium at the same time to control the sterilization temperature.So the temperature was ensuring stabile and effective when sterilization.Compared to the traditional method,heat penetration would be better and the medium could also achieve required F value when sterilized in this method.