Evaluation of Proficiency Validation Results for Air Change Rate Testing in Laboratory Animal Facilities

doi:10.12300/j.issn.1674-5817.2024.101

Abstract

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.

Key words: Laboratory animal, Cleanroom, Air change rate, Proficiency validation, Air flow hood

CLC Number:

Q95-33

LIU Wei,ZHANG Xinyan,HOU Fengtian,et al. Evaluation of Proficiency Validation Results for Air Change Rate Testing in Laboratory Animal Facilities[J]. Laboratory Animal and Comparative Medicine, 2025, 45(1): 87-95. DOI: 10.12300/j.issn.1674-5817.2024.101.

Figures/Tables 8

References 29

1	刘蕾, 罗涛, 胡仰耆, 等. ASHRAE 170-2021关键技术及与中国标准的对比分析[J]. 暖通空调, 2023, 53(11):67-72, 14. DOI: 10.19991/j.hvac1971.2023.11.11 .
	LIU L, LUO T, HU Y Q, et al. Contrastive analysis of key technologies between ASHRAE Standard 170-2021 and Chinese standards[J]. Heat Vent Air Cond, 2023, 53(11):67-72, 14. DOI: 10.19991/j.hvac1971.2023.11.11 .
2	陈红兵, 王文谦, 王聪聪, 等. 北京某高校教室自然通风下新冠感染概率实验和模拟研究[J]. 暖通空调, 2023, 53(5):124-129, 135. DOI: 10.19991/j.hvac1971.2023.05.20 .
	CHEN H B, WANG W Q, WANG C C, et al. Experimental and simulation study on infection rate of SARS-CoV-2 under natural ventilation in classrooms of a university in Beijing[J]. Heat Vent Air Cond, 2023, 53(5):124-129, 135. DOI: 10.19991/j.hvac1971.2023.05.20 .
3	黄晨, 黄翠, 李浩, 等. 非单向流洁净室内含尘浓度分布影响因素的实验研究[J]. 建筑节能(中英文), 2021, 49(5):31-36. DOI: 10.3969/j.issn.2096-9422.2021.05.006 .
	HUANG C, HUANG C, LI H, et al. Experimental study about influencing factors on particle concentration distribution in non-unidirectional flow cleanroom[J]. Build Energy Effic, 2021, 49(5):31-36. DOI: 10.3969/j.issn.2096-9422.2021.05.006 .
4	藤田省吾, 小原彻, 田中郁郎, 等. 实验动物房的换气次数与温度、湿度的分布[J]. 上海畜牧兽医通讯·实验动物科学专辑, 1982, 2(4):218-219, 170.
	FUJITA S, OHARA T, TANAKA I, et al. Distribution of air exchange frequency, temperature and humidity in laboratory animal room[J]. Shanghai Livestock Vet Comm - Lab Anim Sci, 1982, 2(4): 218-219, 170.
5	钟加晨, 王志毅, 吴强. 基于节能的实验动物人工环境气流组织数值模拟[J]. 中国比较医学杂志, 2021, 31(3):104-110. DOI: 10.3969/j.issn.1671-7856.2021.03.016 .
	ZHONG J C, WANG Z Y, WU Q. Numerical simulation of air distribution in an artificial laboratory animal environment designed to minimize energy costs[J]. Chin J Comp Med, 2021, 31(3):104-110. DOI: 10.3969/j.issn.1671-7856.2021.03.016 .
6	李雪柏, 谷鑫, 王晓雪, 等. 变频器在生物安全二级实验室通风系统中的节能应用[J]. 中国医学装备, 2020, 17(11):205-208. DOI: 10.3969/J.ISSN.1672-8270.2020.11.051 .
	LI X B, GU X, WANG X X, et al. Energy saving application of frequency converter in ventilation system of BSL-2 laboratory[J]. China Med Equip, 2020, 17(11):205-208. DOI: 10.3969/J.ISSN.1672-8270.2020.11.051 .
7	中国合格评定国家认可委员会. 实验室认可规则: CNAS—RL01 [S/OL]. (2019-12-30)[2004-06-08]. .
	China National Accreditation Service for Conformity Assessment. Rules for the Accreditation of Laboratories: CNAS-RL01 [S/OL]. (2019-12-30)[2004-06-08]. .
8	中国合格评定国家认可委员会. 能力验证规则: CNAS—RL02 [S/OL]. (2023-09-30)[2004-06-08]. .
	China National Accreditation Service for Conformity Assessment. Rules for Proficiency Testing: CNAS-RL02 [S/OL]. (2023-09-30)[2004-06-08]. .
9	范春艳, 原鹏飞, 周超. 实验室比对对实验检测质量的控制[J]. 四川水力发电, 2019, 38(5):101-103, 107. DOI: 10.3969/j.issn.1001-2184.2019.05.033 .
	FAN C Y, YUAN P F, ZHOU C. Laboratory comparison for test quality control[J]. Sichuan Water Power, 2019, 38(5):101-103, 107. DOI: 10.3969/j.issn.1001-2184.2019.05.033 .
10	国家市场监督管理总局, 国家标准化管理委员会. 实验动物环境及设施: [S]. 北京: 中国标准出版社, 2010.
	State Administration for Market Regulation, National Standardization Administration. Laboratory animal─ Environment and housing facilities: [S]. Beijing: Standards Press of China, 2010.
11	中国合格评定国家认可委员会. 能力验证样品均匀性和稳定性评价指南: CNAS—GL003 [S/OL]. (2018-03-01)[2004-06-08]. .
	China National Accreditation Service for Conformity Assessment. Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing: CNAS-GL003 [S/OL]. (2018-03-01)[2004-06-08]. .
12	中国合格评定国家认可委员会. 能力验证结果的统计处理和能力评价指南: CNAS—GL002 [S/OL]. (2018-03-01)[2004-06-08]. .
	China National Accreditation Service for Conformity Assessment. Guidance on Statistic Treatment of Proficiency Testing Results and Performance Evaluation: CNAS-GL002 [S/OL]. (2018-03-01)[2004-06-08]. .
13	国家市场监督管理总局, 国家标准化管理委员会. 利用实验室间比对进行能力验证的统计方法: [S]. 北京: 中国标准出版社, 2019.
	State Administration for Market Regulation, National Standardization Administration. Statistical methods for use in proficiency testing by interlaboratory comparison: [S]. Beijing: Standards Press of China, 2019.
14	熊薇, 葛宇. Youden图在实验室能力验证中的应用及绘制方法[J]. 计量技术, 2008(4):63-65, 69. DOI: 10.3969/j.issn.1000-0771.2008.04.020 .
	XIONG W, GE Y. Application and drawing method of Youden diagram in laboratory ability verification[J]. Metrol Sci Technol, 2008(4):63-65, 69. DOI: 10.3969/j.issn.1000-0771.2008.04.020 .
15	王林波, 杨美成, 陈祝康, 等. 运用Excel软件制作Youden图的方法及Youden图在能力验证计划数据统计中的应用[J]. 中国药事, 2012, 26(4):364-367. DOI: 10.16153/j.1002-7777.2012.04.008 .
	WANG L B, YANG M C, CHEN Z K, et al. A method of drawing Youden graph by excel and the application of Youden graph in analysis of proficiency testing result[J]. Chin Pharm Aff, 2012, 26(4):364-367. DOI: 10.16153/j.1002-7777.2012.04.008 .
16	国家质量监督检验检疫总局, 国家标准化管理委员会. 数值修约规则与极限数值的表示和判定: [S]. 北京: 中国标准出版社, 2008.
	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; National Standardization Administration. Rules of rounding off for numerical values & expression and judgement of limiting values: [S]. Beijing: Standards Press of China, 2008.
17	任志伟, 厉龙, 吴振一, 等. 风量仪校准方法的研究[J]. 工业计量, 2017, 27(2):7-9. DOI: 10.13228/j.boyuan.issn1002-1183.2017.9003 .
	REN Z W, LI L, WU Z Y, et al. Study on calibration method of air volume meter[J]. Ind Metrol, 2017, 27(2):7-9. DOI: 10.13228/j.boyuan.issn1002-1183.2017.9003 .
18	国家质量监督检验检疫总局. 测量仪器特性评定: [S]. 北京: 中国标准出版社, 2002.
	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China. Evaluation of the characteristice of measuring instruments: [S]. Beijing: Standards Press of China, 2002.
19	国家市场监督管理总局, 国家标准化管理委员会. 洁净室及相关受控环境第3部分:检测方法: [S]. 北京: 中国标准出版社, 2024..
	State Administration for Market Regulation, National Standardization Administration. Cleanrooms and associated controlled environments—Part 3: Test methods: [S]. Beijing: Standards Press of China, 2024.
20	国家质量监督检验检疫总局,国家标准化管理委员会. 洁净室及相关受控环境检测技术分析与应用: [S]. 北京: 中国标准出版社, 2018.
	General Administration of Quality Supervision,Inspection and Quarantine of the People's Republic of China; National Standardization Administration. Cleanrooms and associated controlled environments—Analysis and application of test technology: [S]. Beijing: Standards Press of China, 2018.
21	龚磊, 戚宁武, 龚中字, 等. 风量仪校准方法探讨[J]. 中国计量, 2022(8):117-119. DOI: 10.16569/j.cnki.cn11-3720/t.2022.08.040 .
	GONG L, QI N W, GONG Z Z, et al. Discussion on calibration method of air volume meter[J]. China Metrol, 2022(8):117-119. DOI: 10.16569/j.cnki.cn11-3720/t.2022.08.040 .
22	福建省质量技术监督局. 数字风量罩校准规范: JJF(闽)1068—2015 [S/OL]. (2015-03-01)[2004-06-08]. .
	Fujian Province Bureau of Quality and Technical Supervision. Calibration specification for digital air flow hood: JJF(Min)1068-2015 [S/OL]. (2015-03-01)[2004-06-08]. .
23	incorporated TSl. DP-CALCTM micromanometer model 8715 and ACCUBALANCE® modular air balancing tool moedl 8380 operation and service manual[EB/OL]. [2004-06-08]. .
24	王洪, 魏杰, 邢进, 等. 2013—2021年实验动物质量检测能力验证情况[J]. 实验动物科学, 2024, 41(2):22-27. DOI: 10.3969/j.issn.1006-6179.2024.02.004 .
	WANG H, WEI J, XING J, et al. Study on 2013-2021 proficiency testing of laboratory animals quality monitoring[J]. Lab Anim Sci, 2024, 41(2):22-27. DOI:10.3969/j.issn.1006-6179.2024.02.004 .
25	邢进, 冯育芳, 王洪, 等. 2013—2020年7次实验动物病原菌项目国际比对结果分析[J]. 实验动物与比较医学, 2021, 41(6):521-527. DOI: 10.12300/j.issn.1674-5817.2021.104 .
	XING J, FENG Y F, WANG H, et al. Analysis of seven performance evaluation program results for pathogenic bacteria from laboratory animals in 2013-2020[J]. Lab Anim Comp Med, 2021, 41(6):521-527. DOI: 10.12300/j.issn.1674-5817.2021.104 .
26	王洪, 魏杰, 付瑞, 等. 2011—2017年实验动物遗传质量评价能力验证结果分析[J]. 实验动物科学, 2019, 36(1):1-4, 9. DOI: 10.3969/j.issn.1006-6179.2019.01.001 .
	WANG H, WEI J, FU R, et al. Analysis of proficiency testing results of laboratory animals' genetic quality during 2011-2017[J]. Lab Anim Sci, 2019, 36(1):1-4, 9. DOI: 10.3969/j.issn.1006-6179.2019.01.001 .
27	刘朝朋. 实验室间比对在质量投诉调查中的应用[J]. 石油商技, 2023, 41(1): 92-95. DOI: 10.3969/j.issn.1006-1479.2023.01.014 .
	LIU Z P. Application of inter-laboratory comparison in quality complaint investigation[J]. Petrol Prod Appl Res, 2023, 41(1): 92-95. DOI: 10.3969/j.issn.1006-1479.2023.01.014 .
28	甄书秀. 技术机构如何服务经济发展[N]. 中国质量报, 2011-03-28(4).
	ZHEN S X. How to serve economic development of technical institutions[N]. China Quality Daily, 2011-03-28(4).
29	李玲, 朱爱丽, 荆知敏. 从实验室间比对和能力验证分析基层药检机构的发展[J]. 中国药事, 2022, 36(11):1239-1245. DOI: 10.16153/j.1002-7777.2022.11.005 .
	LI L, ZHU A L, JING Z M. Analysis of the development of primary drug testing institutions from interlaboratory comparisons and proficiency testing[J]. Chin Pharm Aff, 2022, 36(11):1239-1245. DOI: 10.16153/j.1002-7777.2022.11.005 .

实验室设备 Laboratory equipment	第三方检测机构 Third-party laboratory category	实验动物检验检测机构 Laboratory animals testing institution	食品药品检验机构 Food and drug inspection and testing institution	药品生产企业 Pharmaceutical manufacturing enterprise	总计 Total
各品牌风量罩 Various brands of air flow hoods
加野KANOMAX	/	1	/	/	1
Shortridg	/	1	/	/	1
宏瑞净化Honri airclean	/	/	/	1	1
华宇净化 HuaYu purification equipment	/	/	/	1	1
西瓦卡Cvokly	/	1	/	/	1
苏净SuJing	/	/	1	1	2
凯茂KIMO	/	/	2	/	2
德图TESTO	/	2	/	1	3
特赛TSI	3	8	4	/	15
不同测距设备 Different ranging equipment
钢卷尺Steel measuring tapes	1	2	1	2	6
激光测距仪Laser distance meters	2	11	6	2	21

实验室设备 Laboratory equipment	第三方检测机构 Third-party laboratory category	实验动物检验检测机构 Laboratory animals testing institution	食品药品检验机构 Food and drug inspection and testing institution	药品生产企业 Pharmaceutical manufacturing enterprise	总计 Total
各品牌风量罩 Various brands of air flow hoods
加野KANOMAX	/	1	/	/	1
Shortridg	/	1	/	/	1
宏瑞净化Honri airclean	/	/	/	1	1
华宇净化 HuaYu purification equipment	/	/	/	1	1
西瓦卡Cvokly	/	1	/	/	1
苏净SuJing	/	/	1	1	2
凯茂KIMO	/	/	2	/	2
德图TESTO	/	2	/	1	3
特赛TSI	3	8	4	/	15
不同测距设备 Different ranging equipment
钢卷尺Steel measuring tapes	1	2	1	2	6
激光测距仪Laser distance meters	2	11	6	2	21

分值 Score	打分明细 Score breakdown
50	两个Z值均为“\|Z\|≤2”
40	一个Z值为“\|Z\|≤2”，另一个Z值为“2＜\|Z\|＜3”
30	一个Z值为“\|Z\|≤2”，另一个Z值为“\|Z\|≥3”
20	两个Z值均为“2＜\|Z\|＜3”
10	一个Z值为“2＜\|Z\|＜3”，另一个Z值为“\|Z\|≥3”
0	两个Z值均为“\|Z\|≥3”

分值 Score	打分明细 Score breakdown
50	两个Z值均为“\|Z\|≤2”
40	一个Z值为“\|Z\|≤2”，另一个Z值为“2＜\|Z\|＜3”
30	一个Z值为“\|Z\|≤2”，另一个Z值为“\|Z\|≥3”
20	两个Z值均为“2＜\|Z\|＜3”
10	一个Z值为“2＜\|Z\|＜3”，另一个Z值为“\|Z\|≥3”
0	两个Z值均为“\|Z\|≥3”

设备类型 Type of meters	参数 Parameter	房间1 Room 1	房间2 Room 2
钢卷尺 Steel measuring tapes	长	3.675±0.018	4.264±0.028
	宽	2.053±0.033	3.769±0.029
	高	2.693±0.012^**	2.700±0.006^**
激光测距仪 Laser distance meters	长	3.683±0.005	4.265±0.003
	宽	2.050±0.012	3.761±0.006
	高	2.705±0.003^**	2.705±0.003^**