中国药业2024，Vol.33Issue(2)：68-71,4.DOI:10.3969/j.issn.1006-4931.2024.02.016
我国24家检验检测机构洁净环境照度检测能力验证
Proficiency Testing for Illuminance Detection of Clean Environment of 24 Inspection and Testing Institutes in China
摘要
Abstract
Objective To evaluate the proficiency of Chinese inspection and testing institutes on the illuminance detection of clean environment.Methods A proficiency testing program for illuminance detection of pharmaceutical clean environment firstly designed and implemented nationwide by National Institutes for Food and Drug Control in 2022 was retrospectively analyzed.Based on the characteristics of clean environment testing industry,this program included written examination and practical operation.The written examination consisted of three questions(limited to 40 min to complete),aiming to assess the correct understanding and mastery degree of participating laboratories on testing standards,and it was evaluated according to the scoring criteria determined by experts(a maximum of 50 points).Two clean workbenches from the Institute for Pharmaceutical Excipients and Packaging Materials Control,National Institutes for Food and Drug Control were used as the samples in practical operation to assess the instrument operation and testing level of participating laboratories(limited to 5 min to complete).The results of on-site testing were evaluated by Z-value(︱Z︱≤2,2<︱Z︱<3,︱Z︱≥3 refer to satisfactory,questionable and unsatisfactory results)and scored(a maximum of 50 points).The testing capacity of participating laboratories was evaluated based on the sum of written examination and practical operation scores,with≥60 points as qualification.Results A total of 24 laboratories participated in this proficiency testing and submitted reports as required.The score of written examination was in the range of 45 to 50 points,with 21 laboratories getting full scores(87.50%).For sample A,the practical operation of 21 laboratories was satisfactory(87.50%),while that of three was questionable(12.50%);for sample B,that of 23 laboratories was satisfactory(95.83%),while that of one was questionable(4.17%),and there was no unsatisfactory result for both samples.The total score of 24 laboratories was all qualified.Conclusion This proficiency testing shows that the testing capacity of each laboratory is good.However,some laboratories still lack understanding and mastery of the standards or do not meter the lumeter according to the calibration cycle.It is suggested that the testing personnel should increase understanding of clean environment testing standards,and corresponding institutes should pay attention to instrument calibration to continuously improve the testing capability.关键词
检验检测机构/洁净环境/照度/能力验证Key words
inspection and testing institute/clean environment/illuminance/proficiency testing分类
医药卫生引用本文复制引用
田霖,刘雅丹,项新华,谢兰桂,杨会英..我国24家检验检测机构洁净环境照度检测能力验证[J].中国药业,2024,33(2):68-71,4.基金项目
中国食品药品检定研究院学科带头人培养基金立项课题[2023X9]. （）
