实验动物与比较医学2025，Vol.45Issue(1)：87-95,9.DOI:10.12300/j.issn.1674-5817.2024.101
实验动物设施换气次数检测能力验证结果评价
Evaluation of Proficiency Validation Results for Air Change Rate Testing in Laboratory Animal Facilities
刘巍 1张心妍 1侯丰田 1许中衍 1马丽颖1
作者信息
- 1. 中国食品药品检定研究院,北京 102629||国家啮齿类实验动物资源库,北京 102629
- 折叠
摘要
Abstract
Objective By organizing and implementing a laboratory proficiency validation plan for air change rate testing,this study aims to explore proficiency testing approaches in laboratory animal facilities,assess the current status of relevant laboratories regarding standard application and test capabilities,standardize air change rate testing methods,and ensure the accuracy and reliability of test results.Methods From September to November 2023,the National Institutes for Food and Drug Control(NIFDC)organized a laboratory proficiency validation plan for air change rate testing in laboratory animal facilities(Plan Number:NIFDC-PT-417).The proficiency testing was conducted on-site and consisted of two parts:a written test and practical operation.The written test was open-book.True/false questions focused on participants'understanding of specific clauses in relevant standards,while application-based questions assessed their ability to handle data processing in simulated testing scenarios.The practical operation was conducted according to the relevant criteria of the China National Accreditation Service for Conformity Assessment(CNAS).Two laboratory animal rooms were prepared as proficiency testing samples using a sample splitting approach.These rooms underwent uniformity and stability testing according to CNAS requirements and were approved.Participating laboratories were required to conduct three tests on each of the two laboratory animal rooms,complete the testing and calculation of air change rate within the specified timeframe,and submit their test result reports and original records.Results A total of 27 laboratories registered and participated in the proficiency testing.All participating laboratories submitted their results within the designated timeframe,and the outcomes of all tested laboratories were rated as satisfactory.Conclusion This proficiency validation program objectively and scientifically evaluates the air change rate testing capabilities of selected domestic laboratories,effectively promoting the overall improvement of testing capabilities in the industry.It provides technical support for regulatory authorities to standardize testing institutions and offers reliable references for the purchase of testing services.Through this activity,it was identified that some laboratories need to further enhance their calibration of instruments and the utilization of calibration results.Future efforts should focus on refining related standards to improve the accuracy and reliability of testing.关键词
实验动物/洁净室/换气次数/能力验证/风量罩Key words
Laboratory animal/Cleanroom/Air change rate/Proficiency validation/Air flow hood分类
生物学引用本文复制引用
刘巍,张心妍,侯丰田,许中衍,马丽颖..实验动物设施换气次数检测能力验证结果评价[J].实验动物与比较医学,2025,45(1):87-95,9.
