洁净环境生物污染检测实验室间比对研究  

Comparative research between laboratories for biological contamination testing in clean environment

作　　者：田霖[1] 赵燕君 仪忠勋 吴慧 谢兰桂[1] 杨会英[1] TIAN Lin;ZHAO Yan-jun;YI Zhong-xun;WU Hui;XIE Lan-gui;YANG Hui-ying(NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院国家药品监督管理局药用辅料质量研究与评价重点实验室,北京100050

出　　处：《中国医药生物技术》2023年第4期328-332,共5页Chinese Medicinal Biotechnology

基　　金：中国食品药品检定研究院学科带头人培养基金(2023X9)。

摘　　要：目的设计并组织实施洁净环境生物污染检测实验室间比对项目,评价实验室的生物污染检测能力,识别实验室间存在的差异。方法制备洁净环境检测用阳性质控品,并进行均匀性和稳定性考察,对实验室间比对结果进行统计分析并评价。结果样品均匀性和稳定性符合要求。7家实验室参加洁净环境生物污染检测项目,满意数为7家,满意率100%。结论各实验室检测能力维持良好,洁净环境检测用阳性质控品可用于生物污染检测能力的实验室间比对,为今后开展洁净环境生物污染检测能力验证项目提供参考。Objective A proficiency testing program was designed and conducted for detecting biological contamination of clean environment in order to evaluate the testing capacity and level of related laboratories.Methods Positive quality control products for clean environment testing were prepared,the uniformity and stability investigations were conducted,and the results of inter-laboratory comparison were statistically analyzed and evaluated.Results Sample uniformity and stability met requirements.7 laboratories participated in the clean environment biological pollution testing project,and the number of satisfaction was 7 with a satisfaction rate of 100%.Conclusion The testing capacity of each laboratory is maintained well,and the positive quality control for clean environment testing can be used for inter-laboratory comparison of biological pollution detection capabilities,so as to provide reference for the verification projects in ability of future clean environment biological pollution detection.

关 键 词：洁净环境 生物污染 阳性质控品 实验室间比对 沉降菌 浮游菌 

分 类 号：TU834.844[建筑科学—供热、供燃气、通风及空调工程]