隔离系统环境监测平皿微生物试验回收率影响因素

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英文篇名：Influence Factors on Microbial Recovery of Environmental Monitoring Media Plates Used in Isolator Systems 作者：潘伟婧 ; 厉高慜 ; 林梅 ; 张玫 ; 彭兴盛 英文作者：PAN Weijing;LI Gaomin;LIN Mei;ZHANG Mei;PENG Xingsheng;Shanghai Institute for Food and Drug Control; 关键词：隔离系统 ; 环境监测平皿 ; 回收率 ; 影响因素 英文关键词：isolator systems;;environmental monitoring media plates;;microbial recovery;;influence factors 中文刊名：中国医药工业杂志 英文刊名：Chinese Journal of Pharmaceuticals 机构：上海市食品药品检验所; 出版日期：2019-02-20 11:02 出版单位：中国医药工业杂志 年：2019 期：01 基金：国家药典委员会药品医疗器械审评审批制度改革有关药品标准研究(ZG2016-4-01) 语种：中文; 页：110-114 页数：5 CN：31-1243/R ISSN：1001-8255 分类号：X830

摘要

为研究无菌检查用隔离系统环境监测平皿微生物试验回收率的影响因素,本文对不同来源的环境监测平皿进行了测试。通过微生物的回收率作为评价指标,评估包装材料、灭菌剂注入量、灭菌循环次数等因素对回收率的影响。结果表明,灭菌剂注入量、包装材料和包装形式对环境监测平皿上微生物回收率的影响较大;灭菌次数对回收率也有一定影响;金黄色葡萄球菌和铜绿假单胞菌对汽化过氧化氢灭菌剂的敏感程度较高。隔离系统应用于无菌检查时,应对培养基和样品包装进行完整性验证,排除灭菌处理可能带来的假阴性风险。
        To investigate the influence factors affecting microbial recovery of environmental monitoring media plates used in sterilitytesting isolator systems, different sources of media plates were tested. Microbial recovery was taken as the evaluation index. Possible influence factors such as packing materials, the injection amount of decontaminating agent, rounds of decontamination cycle were assessed. The results revealed that the injection amount of decontaminating agent, packing materials and packing forms had great influences on microbial recovery of environmental monitoring media plates. Rounds of decontamination cycle also influenced microbial recovery to some extent. Staphylococcus aureusand Pseudomonas aeruginosa were quite sensible when exposed to vapor of hydrogen peroxide. When the isolator systems were applied to sterility testing, package integrity verification should be performed to eliminate false negative risks caused by decontamination treatment.

引文

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