Practice on Validity Period Management of Disinfectants, Feed and Bedding in Laboratory Animal Facilities under Good Laboratory Practice for Non-Clinical Pharmaceutical Research Management System

doi:10.12300/j.issn.1674-5817.2025.162

Abstract

Abstract:

Objective To meet the management requirements of Good Laboratory Practice for Non-clinical Pharmaceutical Research (GLP), our center focuses on addressing the problem that the specifications for the validity periods of disinfectants, feed and bedding in the laboratory animal facility lack data support during their application process. We have conducted special verification research and summarized the practical experience of material management, providing a scientific basis and reference for the standardized management of materials in the laboratory animal facility. Methods Under the daily operating environment of the GLP laboratory animal facility in our center,the disinfection efficacy of four commonly used disinfectants was confirmed via the quantitative suspension kill test, with the disinfectants tested on day 0 and day 7 after preparation, as well as on day 0, day 7, and at 1month, 2month, and 3 months after opening. For laboratory animal feed, nutritional components, chemical contamination, and microbial indicators were detected 7 days after opening. Microbiological indicators were also tested on both SPF-grade laboratory animal-specific corncob bedding stored for 7 days after opening and conventional-grade corncob bedding stored for 7 days after autoclaving. Results Within the laboratory animal facility under the GLP management system of our center, the log reduction values of disinfection efficacy for 1% 84 disinfectant, 0.1% Baidusha, and 0.2% benzalkonium bromide were all ≥ 5 on day 0 and day 7 after preparation. For 75% alcohol, the log reduction values remained ≥5 on day 0, day 7, and at 1, 2, and 3 months after opening, all the above disinfectants were determined to be qualified and effective. Compared with the factory inspection data, the nutritional components, chemical contamination, and microbial indicators of the maintenance diets for SPF rats and mice, growth and reproduction diets for SPF guinea pigs, growth and reproduction diets for conventional guinea pigs, maintenance diets for rabbits, and maintenance diets for dogs showed a slight overall downward trend but no significant fluctuations at 7 days of opening, and all indicators still met the relevant requirements of GB/T 14924.2-2001 Hygienic Standard for Formula Feeds for Laboratory Animals and GB 14924.3-2010 Nutritional Components of Formula Feeds for Laboratory Animals. Similarly, Compared with factory quality inspection data, the microbial indicators of specialized corncob bedding for SPF-grade laboratory animals stored for 7 days after opening and conventional-grade corncob bedding stored for 7 days after autoclaving showed no significant fluctuations, and also conform to the above-mentioned hygienic standards. Conclusion Combined with the management practice and practical experience of the GLP laboratory animal facility in our center, the set validity periods of disinfectants, feed and bedding have been verified to meet the quality requirements through the detection and validation of core quality indicators, which can provide a practical reference for the standardized management of laboratory animal facilities.

Key words: Good laboratory practice for non-clinical pharmaceutical research(GLP), Disinfectant, Feed, Bedding, Expiry date, Material management

CLC Number:

Q95-33

MA Wenjing,LIU Yanping,LI yifan,et al. Practice on Validity Period Management of Disinfectants, Feed and Bedding in Laboratory Animal Facilities under Good Laboratory Practice for Non-Clinical Pharmaceutical Research Management System[J]. Laboratory Animal and Comparative Medicine. DOI: 10.12300/j.issn.1674-5817.2025.162.

Figures/Tables 6

References 22

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名称 Name	存放周期 Storage period	活菌计数结果（cfu/mL） Viable bacterial count results	实测杀灭对数值（KL） Actual measured killing logarithm value（KL）	可接受标准 Acceptable standards	是否合格 qualified
1% 84消毒液 1% 84 Disinfectant	消毒剂存放第0d	2.5×10³	5	杀灭对数值均≥5	合格
0.1％百毒杀溶液 0.1% Baidusha		1×10³	5		合格
0.2%新洁尔灭溶液 0.2% Benzalkonium bromide		4×10³	5		合格
阳性对照 Positive control		5×10⁸	/		/
1% 84消毒液 1% 84 Disinfectant	消毒剂存放第7d	5.5×10³	5	杀灭对数值均≥5	合格
0.1％百毒杀溶液 0.1% Baidusha		6×10³	5		合格
0.2%新洁尔灭溶液 0.2% Benzalkonium bromide		8×10³	5		合格
阳性对照 Positive control		4.7×10⁸	/		/

名称 Name	存放周期 Storage period	活菌计数结果（cfu/mL） Viable bacterial count results	实测杀灭对数值（KL） Actual measured killing logarithm value（KL）	可接受标准 Acceptable standards	是否合格 qualified
1% 84消毒液 1% 84 Disinfectant	消毒剂存放第0d	2.5×10³	5	杀灭对数值均≥5	合格
0.1％百毒杀溶液 0.1% Baidusha		1×10³	5		合格
0.2%新洁尔灭溶液 0.2% Benzalkonium bromide		4×10³	5		合格
阳性对照 Positive control		5×10⁸	/		/
1% 84消毒液 1% 84 Disinfectant	消毒剂存放第7d	5.5×10³	5	杀灭对数值均≥5	合格
0.1％百毒杀溶液 0.1% Baidusha		6×10³	5		合格
0.2%新洁尔灭溶液 0.2% Benzalkonium bromide		8×10³	5		合格
阳性对照 Positive control		4.7×10⁸	/		/

名称 Name	存放周期 Storage period	活菌计数结果（cfu/mL） Viable bacterial count results	实测杀灭对数值（KL） Actual measured killing logarithm value（KL）	可接受标准 Acceptable standards	是否合格 qualified
75%酒精 75% Alcohol 阳性对照 Positive control	第0d	8.5×10³ 5×10⁸	5 /	杀灭对数值均≥5	合格 /
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第7d	8.5×10³	5		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		5×10³	5		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		6×10³	5		合格
阳性对照 Positive control		4.7×10⁸	/		/
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第1个月	4.5×10³	5		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		6×10³	5		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		8×10³	5		合格
阳性对照 Positive control		2.3×10⁸	/		/
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第2个月	0	8		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		4.5×10³	5		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		7×10³	5		合格
阳性对照 Positive control		1.92×10⁸	/		/
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第3个月	5.5×10³	5		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		0	8		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		5×10³	5		合格
阳性对照 Positive control		1.28×10⁸	/		/

名称 Name	存放周期 Storage period	活菌计数结果（cfu/mL） Viable bacterial count results	实测杀灭对数值（KL） Actual measured killing logarithm value（KL）	可接受标准 Acceptable standards	是否合格 qualified
75%酒精 75% Alcohol 阳性对照 Positive control	第0d	8.5×10³ 5×10⁸	5 /	杀灭对数值均≥5	合格 /
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第7d	8.5×10³	5		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		5×10³	5		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		6×10³	5		合格
阳性对照 Positive control		4.7×10⁸	/		/
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第1个月	4.5×10³	5		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		6×10³	5		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		8×10³	5		合格
阳性对照 Positive control		2.3×10⁸	/		/
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第2个月	0	8		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		4.5×10³	5		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		7×10³	5		合格
阳性对照 Positive control		1.92×10⁸	/		/
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第3个月	5.5×10³	5		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		0	8		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		5×10³	5		合格
阳性对照 Positive control		1.28×10⁸	/		/

营养成分 Nutritional ingredient	普通级豚鼠生长繁殖饲料/(g•kg^-1) Ordinary grade guinea pig growth and reproduction feed/(g•kg^-1)				兔维持饲料/(g•kg^-1) Rabbit maintains feed/(g•kg^-1)				犬维持饲料/(g•kg^-1) Dog maintains feed/(g•kg^-1)				SPF大、小鼠维持饲料/(g•kg^-1) SPF mice maintain feed/(g•kg^-1)				SPF豚鼠生长繁殖饲料/(g•kg^-1) SPF guinea pig growth and reproduction feed/(g•kg^-1)
营养成分 Nutritional ingredient	规定值	出厂值	检测值	是否符合	规定值	出厂值	检测值	是否符合	规定值	出厂值	检测值	是否符合	规定值	出厂值	检测值	是否符合	规定值	出厂值	检测值	是否符合
水分(≤) Moisture(≤)	110	56	104	是	110	105	75	是	100	88	69	是	100	14	82	是	110	93	104	是
粗蛋白(≥) Crude Protein(≥)	170	224.2	192.3	是	140	141	149.5	是	200	206.8	209.1	是	180	221.1	184.9	是	170	201	201.7	是
粗脂肪(≥) Crude Fat(≥)	30	42	33	是	30	41	34	是	45	94	88	是	40	62	43	是	30	41	39	是
粗纤维 Crude Fiber	100～150	137	101	是	100～150	148	137	是	≤40	28	18	是	≤50	42	33	是	100～150	107	101	是
粗灰分(≤) Crude Ash(≤)	90	80	83	是	90	85	85	是	90	46	48	是	80	66	68	是	90	86	82	是
钙 Ca	10～15	13.6	14.9	是	10～15	12.9	12.5	是	7～10	7.56	9.89	是	10～18	12.6	14.9	是	10～15	14.8	14.8	是
磷 P	5～8	7.8	7.6	是	5～8	7.7	6.4	是	5～8	6.2	7.1	是	6～12	7.6	8.9	是	5～8	8.0	7.6	是