我国15家检验检测机构洁净环境风速检测能力验证

Proficiency Testing for the Airflow Velocity Test of Clean Environment in 15 Inspection and Testing Institutes in China

目的了解和评价我国检验检测机构对洁净室及相关受控环境(简称洁净环境)检测基本项目“风速”的检测技术水平。方法回顾2022年中国食品药品检定研究院首次在检验检测机构内组织实施的洁净环境“风速”检测能力验证计划。该项目采用笔试和实际操作(简称实操)结合的方式综合评价参测实验室的检验技术能力,其中笔试部分为限时闭卷考核(共3题),考核参测实验室对洁净环境“风速”检测标准理解的正确情况和掌握程度,根据专家商议确定的评分标准逐个考点计分;实操为现场考察参测实验室的仪器操作和检测水平,本轮次数据通过分割水平对方式进行评价。结果15家参测实验室的结果评定均为“满意”(≥60分);笔试,8家为50分(满分),7家为39~45分;实操,13家为50分(满分),2家为40分。结论本次能力验证客观科学地初步评估了全国部分检验检测机构的检测能力,促进了行业整体检测水平的提升。但同时也发现部分实验室对标准的理解和掌握仍有欠缺,对仪器的校准及校准结果的利用不够充分,有待进一步改进。

Objective To understand and evaluate the testing level for the basic parameter″airflow velocity″of the cleanrooms and associated controlled environment(hereinafter referred to as the clean environment)drug in inspection and testing institutes in China.Methods The proficiency testing plan for″airflow velocity″test of clean environment in testing institutes organized firstly by the National Institutes for Food and Drug Control in 2022 was analyzed retrospectively.The combination of written examination and experimental operation was used to comprehensively evaluate the proficiency of the participating laboratories.The written examination was conducted in a limited time closed-book format(three questions in total)to assess the correct understanding and mastery degree of participating laboratories for the″airflow velocity″testing standards of clean environment,and the score was obtained according to the scoring standard determined by the expert consultation.The experimental operation was for the on-site inspection of the instrument operation and testing level of the participating laboratories,and the score was obtained by split-level test samples of the test data in this proficiency testing.Results The results of 15 participating laboratories were rated as″satisfactory″(≥60 points).In the written examination,eight laboratories scored full marks(50 points),and seven scored in the range of 39 to 45 points.In the experimental operation,13 laboratories scored full marks(50 points),and two scored 40 points.Conclusion This proficiency testing objectively and scientifically evaluates the testing capability of some inspection and testing institutes in China,and promotes the overall testing level of the industry.However,it is also found that some laboratories still lack understanding and mastery of standards,and neglect the calibration of instruments and the utilization of calibration results,which need further improvement.