| 陈伟盛,潘雯,朱晓燕.辐射灭菌不同剂量设定方法的比较[J].中国药品标准,2019,20(6):500-504 |
| 辐射灭菌不同剂量设定方法的比较 |
| Comparisonof Different Method Establishing the Sterilization Dose of Radiation |
| 投稿时间：2019-01-14 修订日期：2019-11-21 |
| DOI： |
| 中文关键词: 辐射灭菌 灭菌剂量 灭菌法 |
| 英文关键词: Radiation Sterilization dose Sterilization |
| 基金项目:药品医疗器械审评审批制度改革专项课题——灭菌法（ZG2017-4-03） |
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| 中文摘要: |
| 摘要 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D10值，然后通过D10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、VDmax法的灭菌剂量分别为24.5kGy，19.2kGy，25kGy，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VDmax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。 |
| 英文摘要: |
| Abstract Objective: Comparing the advantages and disadvantages of 3 common methods establishing sterilization dose of radiation, the paper gives the suggestion of methods screening for enterprise. Methods: Irradiate quantitative bio-pellets at a series doses and get D10 value. According to the result, it can calculate theoretical dose and make a comparison of dose getting form 3 different methods. Results:The sterilization doses, getting from method 1, method 2 and method VDmax, are 24.5kGy, 19.2kGy and 25kGy. Deviations are 97.6%, 54.8%, 101.6%, comparing the theoretical dose. Conclusion: Method 2 is more suitable for resistance of sample, although it is more sample consumption and higher cost. Radiation sterilization cost and does setting cost should be considered, if method 2 is used as routine sterilization. Method VDmax is more tradition, less sample consumption, but lower cost. It is fir for the sample which is high risk, more value and hard for acquiring. It is moderate sample consumption and tradition for method 1. Method 1 is used as routine sterilization for medical apparatus and instrument. Enterprise can select suitable method considering their product risk and demands. |
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