医用手术台罩辐射灭菌初始污染菌数量的动态观察

DYNAMIC OBSERVATION ON INITIAL CONTAMINATING BACTERIA COUNT ON MEDICAL OPERATION TABLE COVER STERILIZED BY RADIATION

目的了解一次性医用手术台罩初始污染菌量的动态变化,以确定单一辐照剂量25 kGy辐射灭菌的安全性,为厂家的GMP生产提供参考。方法依据ISO11737-1推荐的方法进行初始污染菌数量的检测和产品洗脱菌回收率检测。结果对某企业随机抽取的40个样品检出初始污染菌数量范围为998-1774 cfu/件,校正因子为1.28-1.46。结论该企业现采用25KGy辐照剂量照射法对于医用手术台罩灭菌不具备可靠的安全性;提示在辐射灭菌剂量确定后,应进行持续有效的定期审核。

Objective To know the dynamic changes of initial contaminating bacteria count on the disposable medical operation table cover in order to determine the safety of radiation sterilization with single radiation dose of 25 kGy to provide the reference for GMP production of the manufacturer. Methods Examination of initial contaminating bacteria count and examination of recovery rate of bacteria washed down from the product were carried out according to the methods recommended in ISO11737 - 1. Results The range of initial contaminating bacteria count detected from 40 samples randomly taken from an enterprise was 998 - 1774 cfu/piece, with a correction factor of 1.28 - 1.46. Conclusion At present, the enterprise uses radiation sterilization with 23 kGy radiation dose, which does not possess reliable safety for sterilization of medical operation table cover, indicating that continuous effective periodic examination should be carry out after the sterilization dosage is determined.