辐射灭菌不同剂量设定方法的比较

Comparison of different doses setting methods of radiation sterilization

目的:比较分析3种常用灭菌剂量设定方法的适用性,为企业选择剂量设定方法提供参考。方法:本文采用系列辐射剂量对定量菌球进行辐射处理,根据辐射结果获得菌球的D 10值,然后通过D 10值计算理论剂量,最后与3种设定方法获得的剂量进行比较。结果:方法1、方法2、VD max法的灭菌剂量分别为24.5 kGy,19.2 kGy,25 kGy,与理论灭菌剂量的偏差分别为97.6%、54.8%、101.6%。结论:使用方法2设定的灭菌剂量最接近于产品微生物辐射抗力所需的灭菌剂量,但其所需样本量最大,其灭菌剂量设定成本最高,在日常实践中,需要考量日常辐照灭菌成本与剂量设定成本的平衡;使用VD max法设定的灭菌剂量是较为保守的,由于样本量小,其灭菌剂量设定成本最低,适用于风险较高、附加值较高且样本不易获得的产品的;由于方法1要求的样本适中且兼具有一定的保守性,使用方法1进行灭菌剂量设定是医疗器械行业较为通行做法,企业需要根据实际需求兼顾产品风险选择合适的剂量设定方法。

Objective:To compare and analyze the suitability of 3 common methods setting radiation sterilization dose and to provide the reference for enterprise to choose sterilization dose setting method.Methods:The quantitative bio-pellets were sterilized with the serial radiation doses,D 10 value was obtained by the radiation results,then theoretical dose was calculated.The theoretical dose was compared to the radiation doses obtained by 3 dose setting methods.Results:The sterilization doses of method 1,method 2 and method VD max are 24.5 kGy,19.2 kGy and 25 kGy respectively.The deviations from the theoretical dose are 97.6%,54.8%and 101.6%respectively.Conclusion:The sterilization dose set with method 2 approaches to that of radiation resistance,but method 2 has more sample consumption and its sterilization dose setting cost is highest.Radiation sterilization cost and doses setting cost should be balanced.The sterilization dose obtained by method VD max is more conservative,and the sterilization dose setting cost is lowest as less sample consumption,and it is suitable for the samples which have the high risk,high value-added and are different to obtain.Method 1 has the moderate sample consumption and is a little conservative.Method 1 is used for routine sterilization dose setting in medical devices industry.The enterprise considers the real need and risk to select the suitable doses setting method.