实验动物设施换气次数检测能力验证结果评价

doi:10.12300/j.issn.1674-5817.2024.101

摘要/Abstract

摘要：

目的通过组织实施换气次数检测实验室能力验证计划，探索实验动物设施环境领域能力验证方式，初步了解相关实验室在标准应用及检测水平的现状，规范换气次数检测方法，确保检测结果的准确性和可靠性。方法 2023年9—11月，中国食品药品检定研究院负责组织开展实验动物设施换气次数检测的实验室能力验证计划（编号NIFDC-PT-417）。此次能力验证计划的现场测试分为两个部分：笔试和实际操作。笔试采用开卷形式，判断题着重考察参加者对标准条款的掌握情况，应用题则是通过构建模拟检测场景考察实验人员对数据处理的应用；实际操作按照中国合格评定国家认可委员会（China National Accreditation Service for Conformity Assessment，CNAS）相关准则，通过分割水平样品对的形式，准备2个实验房间作为能力验证样品。2个房间均按照CNAS相关要求，经过均匀性、稳定性测试，并且测试结果合格。参与能力验证的实验室需要对这2个实验间各进行3次测试，要求在规定时间内完成换气次数的检测和计算，并提交本次检测的结果报告单和原始记录。结果共有27家实验室报名并参加本次能力验证，均在规定时间内反馈结果，所有参测实验室的结果均被评定为满意。结论本次能力验证客观且科学地评估了国内部分实验室在换气次数方面的检测能力，有效地促进了行业整体检测水平的提升，为监管部门规范检测机构提供了技术支撑，为委托单位购买检测服务提供了可靠的参考依据。通过本次能力验证，组织方发现部分实验室对仪器的校准及校准结果的利用不够充分，未来需进一步完善相关标准，以提高检测的准确性和可靠性。

关键词: 实验动物, 洁净室, 换气次数, 能力验证, 风量罩

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

中图分类号:

Q95-33

刘巍,张心妍,侯丰田,等. 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. DOI: 10.12300/j.issn.1674-5817.2024.101.

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.

图/表 8

表1 27家实验室的设备使用情况

Table 1 Equipment usage status of 27 laboratories

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

表2 实际操作打分明细

Table 2 Score breakdown of actual operations

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”

图1 换气次数结果分布图注：A、B分别代表房间1和房间2的换气次数结果分布；ACH，换气次数。

Figure 1 Distribution chart of air change rate resultsNote： A and B represent the distribution of air change rates for Room 1 and Room 2 respectively； ACH， air change rate.

表3 27家参与实验室的反馈结果汇总统计量

Table 3 The summary statistics of the feedback results from 27 laboratories

统计量

Statistics

参加实验室数/个

Number of laboratories

中位值/ACH

Median/ACH

标准化四分位距（NIQR）

Normalized interquartile range

稳健CV/%

Robust CV/%

最大值/ACH

Maximum/ACH

最小值/ACH

Minimum/ACH

极差/ACH

Range/ACH

房间1

Room 1

房间2

Room 2

图2 27家实验室参与测试的实验室间和实验室内分数值注：A，实验室间比分数（ZB，Z指代ZB），ZB表示实验室间比分数，用于评估不同实验室之间的测量一致性；B，实验室内比分数（ZW，Z指代ZW），ZW表示实验室内比分数，用于评估同一实验室内部测量结果的稳定性。

Figure 2 The inter-laboratory score and intra-laboratory score score values tested by 27 laboratoriesNote：A represents the inter-laboratory score （ZB， Z represents ZB）， where ZB stands for the inter-laboratory score used to evaluate the consistency of measurements among different laboratories； B represents the intra-laboratory score （ZW， Z represents ZW）， where ZW stands for the intra-laboratory score used to assess the stability of measurement results within the same laboratory.

图3 结果分布尧敦图注：图中的内、外圈椭圆分别表示95%和99%概率的置信区域，椭圆的中心为2个房间中位值的交点将各实验室的结果对输入坐标体系，尧敦图中每个实验室的结果对用圆点表示，其中有2家实验室对应的是同一圆点（即同数值）。

Figure 3 Youden plot of result distributionNote：The inner and outer ellipses in the graph represent confidence regions with probabilities of 95% and 99%， respectively. The center of the ellipses corresponds to the intersection point of the median values of the two rooms. All laboratory results are plotted on this coordinate system， with each laboratory's result represented by a data point in the Youdun diagram. Two laboratories correspond to the same data point （i.e.， the same value）.

表4 房间边长与不同测量设备的相关性验证 (xˉ±s，N=27)

Table 4 Verification of the correlation between room side length and different measuring devices

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^**

表5 本次参比风量仪校准依据

Table 5 Calibration basis of the wind gauge in this experiment

序号 Serial number	标准名称 Standard name	标准号 Standard code
1	风量罩计量校准规范	JCJ/I201004.1
2	数字风量罩校准规范	JJF（闽）1068—2015
3	差压式流量计	JJG 640—2016
4	电接风向风速仪	JJG 613—1989
5	数字压力计	JJG 875—2019
6	风量罩校准规范	JJF（苏）179—2015
7	热球式换气次数仪	JJG（建设）0001—1992
8	风量罩校准规范	JJF（辽）230—2015
9	风量罩校准规范	JJF（浙）1150—2018
10	风量罩计量校准规范	JJF（京）116—2023

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