针对应急抽验一次性病毒采样管微生物限度检测方法的探讨  

The Microbial Limit Detection Method of Disposable Virus Sampling Tube

作　　者：钟静[1] 杨立峰[1] 崔娉婷 严群 ZHONG Jing;YANG Li-feng;CUI Ping-ting;YAN Qun(Guangdong Institute for Quality Supervision and Inspection of Medical Devices,Guangdong Guangzhou 510663)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《中国医疗器械信息》2023年第7期30-32,共3页China Medical Device Information

基　　金：广东省药品监督管理局科技创新项目(项目名称:体外循环器械重点实验室项目研究,项目编号:2021ZDZ01);广东省重点领域研发计划项目(项目名称:ECMO相关体外循环设备临床前大动物安全性、有效性评价体系建设和规范制定,项目编号:2020B1111490002)。

摘　　要：目的:针对一次性病毒采样管冻存液营养丰富、抑菌性强的特性,建立微生物限度检测方法。方法:T/GDMDMA 0005-2022《样本保存管(含保存液)》标准要求5.6:不具备灭活功能,用于病毒分离培养的本产品,需氧菌总数应不超过200 CFU/mL,霉菌、酵母菌总数应不超过100 CFU/mL;标准方法6.6中微生物指标检测:按照《中华人民共和国药典》(2020年版)四部1105非无菌产品微生物限度检查:微生物计数法中的薄膜过滤法进行检测。此标准未提供微生物指标的详细检测方法,依据《中华人民共和国药典》(2020版)通则1105规定需要对微生物限度方法进行方法适用性验证,建立符合本产品的微生物限度方法,所以文章通过3种方法进行验证比较,方法一:薄膜过滤法,适用性试验:直接取样成为供试液,在供试液中加入试验菌进行验证,取1mL置滤杯中,后冲洗500mL盐水,此方法只有黑曲霉菌种回收率达到药典标准的要求,证明样品抑菌性强;方法二:稀释法,适用性试验:在1:10供试液中加入试验菌进行验证,取1mL置滤杯中,后冲洗500mL盐水;方法三:薄膜过滤法在最后一次冲洗液中加入试验菌,适用性试验:取原液1mL进滤杯,冲洗500mL盐水后,在最后一次100mL冲洗盐水加入试验菌。结论:第二种及第三种方法的回收率符合《中华人民共和国药典》(2020年版)1105要求,故第二及第三种方法是可行的。Objective:To establish a microbial limit detection method for the rich nutrition and antibacterial characteristics of frozen storage liquid in disposable virus sampling tubes.Methods:T/GDMDMA 0005-2022 standard requirements of Sample storage tube(including preservation liquid)5.6:The product does not have inactivation function,the total number of aerobic bacteria should not exceed 200 CFU/mL,and the total number of mold and yeast should not exceed 100 CFU/mL;Microbial indicators in standard method 6.6:according to the 1105 non-sterile products:film filtration method in microbial counting method.This standard does not provide a detailed detection method for the microbial indicators,according to the General Rules 1105 of Chinese Pharmacopoeia(2020),the method applicability of the microbial limit method is verified,establish a microbial limit method consistent with this product,so this paper compares three methods,method 1:film filtration method(suitability test:direct sampling into the test solution,add the test bacteria to the test solution for verification,in the 1 mL filter cup,after flushing 500 mL saline)in this method,only the recovery of the Aspergillus niger species meets the pharmacopoeia standard,demonstrated that the samples were highly antibacterial;Method 2:dilution method(suitability test:add test bacteria to 1:10 test and solution for verification,take 1 mL filter cup and then rinse 500 mL saline);Method 3:film filtration method in the last washing solution(suitability test:take 1 mL of stock solution into the filter cup,after rinsing with 500 mL of saline solution,in the last 100 mL rinse saline was added to the test bacteria).Conclusion:The recovery rate of the second and third methods meets the requirements of Chinese Pharmacopoeia(2020 edition)1105,therefore,the second and third methods are feasible.

关 键 词：应急抽验 一次性病毒采样管 微生物限度检测方法 回收率 

分 类 号：TH776[机械工程—仪器科学与技术]