医用防护产品灭菌过程定义、开发和维护中的无菌检测技术  

Sterility testing technology in the definition,development and maintenance of sterilization process of medical protection products

作　　者：张萌萌 栾同青 莫伟娜 马延兴 栾园园 ZHANG Meng-meng;LUAN Tong-qing;MO Wei-na;MA Yan-xing;LUAN Yuan-yuan(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection/NMPA Key Laboratory for Quality Evaluation of Medical Materials and Biological Protective Devices,Jinan 250101,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院、国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,山东济南250101

出　　处：《中国消毒学杂志》2025年第2期97-99,104,共4页Chinese Journal of Disinfection

基　　金：国家市场监督管理总局科技计划(2021MK181)。

摘　　要：目的 建立医用防护口罩、一次性使用手术衣、藻酸盐敷料灭菌过程定义、开发和维护中的无菌检测技术,并确认其效果。方法 首先建立样品选择、检验量确定、培养基选择、培养条件确定、结果判断的无菌检测新方法,然后对建立的方法进行专属性、检测限、耐用性、重现性方面的验证。结果 专属性结果表明,培养基的专属性良好,可用于5种指示微生物菌株的培养;检测限结果表明,接种≤5 cfu的试验菌,药典方法可检出50%的样品,新方法和药典方法检出率相比差异无统计学意义(P>0.05);耐用性结果表明,当培养温度发生小的变化时,检测结果未受影响,耐用性良好;重现性结果表明,在不同实验室、不同人员、不同时间,采用新方法进行检验,数据重现性良好。结论 新建立的方法适合医用防护产品灭菌过程定义、开发和维护中的无菌检测。Objective To establish the sterility testing technology in the definition,development and maintenance of sterilization process of medical protective masks,disposable surgical gowns and alginate dressings,and to confirm its efficacy.Methods Firstly,a new sterility testing method was established,including sample selection,test quantity determination,medium selection,culture condition determination,and result judgment,and then the specificity,detection limit,durability,and reproducibility of the established method were verified.Results The specificity results showed that the specificity of the medium was good,and it could be used for the culture of five indicator microbial strains.The results of the detection limit showed that 50%of the samples could be detected by the pharmacopoeia method after inoculation with≤5 cfu,and there was no significant difference in the detection rate between the new method and the pharmacopoeia method(P>0.05).The durability results showed that when there was a small change in the incubation temperature,the detection results were not affected,and the durability was good.The reproducibility results showed that the data were reproducible in different laboratories,different personnel,and different times,using the new method to test.Conclusion The newly established method is suitable for sterility testing in the definition,development and maintenance of sterilization process of medical protective products.

关 键 词：医用防护口罩 一次性使用手术衣 藻酸盐敷料 灭菌过程定义 开发和维护 无菌检测 

分 类 号：R187[医药卫生—流行病学]