检测医疗器械非织造布包装材料中初始污染菌的方法  

Detection Methods of Initial Contaminating Bacteria in Nonwoven Packaging Materials

作　　者：李翠 马恒 苗策禹 刘兴翠 郝树彬 LI Cui;MA Heng;MIAO Ceyu;LIU Xingcui;HAO Shubin(NMPA Key Lab.for Quality Evaluation of Medical Materials and Biological Protective Devices,Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan 250101;Food and Drug Evaluation and Inspection Center of Shandong Province,Jinan 250101)

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 [2]山东省食品药品审评查验中心,山东济南250101

出　　处：《中国医药工业杂志》2022年第4期567-571,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了一种适合医疗器械初包装材料即非织造布包装材料的初始污染菌检测方法。通过设计不同的微生物洗脱方式及参数,根据方法回收率的比较结果得到超声波洗脱法的洗脱效果最好,微生物平均回收率(n=10)达52.2%。通过单因素试验以及正交试验,确定超声波洗脱法采集微生物的最佳工艺参数,即超声时间10 min,超声功率40 kHz,洗脱液中Tween-80的用量为2 g/L,洗脱液体积200 ml,此时微生物采集回收率提高到67.2%,较未优化前提高了15.0%,为该包装材料的初始污染菌检测方法提供了参考。A detection method of initial contaminating bacteria was established for the determination of primary packaging material of medical devices,namely nonwoven packaging materials.By designing different microbial elution methods and parameters,and according to the comparison results of the method recovery,the average microbial recovery(n=10)of ultrasonic elution method was the highest that reached 52.2%.According to the results of single factor experiment and orthogonal experiment,the ultrasonic elution method to collect microorganism was determined as the optimal with the following settings:the ultrasonic time was 10 min,the ultrasonic power was 40 kHz,the amount of Tween-80 in the eluent was 2 g/L,and the eluent volume was 200 ml.The recovery of microorganism collection was increased to 67.2%,which was 15.0%higher than that before optimization,which provided a reference for the initial contamination bacteria detection of the packaging material.

关 键 词：医疗器械 非织造布包装材料 初始污染菌 

分 类 号：R181[医药卫生—流行病学]