Practice in Validity Period Management of Disinfectants, Feed, and Bedding in Laboratory Animal Facilities under Good Laboratory Practice Management System

doi:10.12300/j.issn.1674-5817.2025.162

Abstract

Abstract:

Objective To meet the requirements of Good Laboratory Practice (GLP), Sichuan Institute for Drug Control (Sichuan Testing Center of Medical Devices, Sichuan Institute of Musk Deer Breeding) Safety Evaluation Center (hereinafter referred to as the center) conducts a targeted validation study to address the lack of supporting data for the specified validity periods of disinfectants, feed, and bedding during their use in laboratory animal facilities. The study summarizes practical experience in material management and provides a scientific basis for the standardized management of materials in the facility. Methods Under the routine operating conditions of the laboratory animal facility at the center, the disinfection efficacy of four commonly used disinfectants was confirmed using the quantitative suspension kill test, with the disinfectants tested on day 0, day 7, and at 1, 2, and 3 months after preparation and after opening; for laboratory animal feed, nutritional components, chemical contaminants, and microbial indicators were tested 7 days after opening; microbial indicators of laboratory animal corncob bedding were tested after storage for 7 days following opening and sterilization. Results Under the GLP management system of our center, the disinfection efficacy log reduction values of prepared 0.04% sodium hypochlorite solution, 0.1% didecyldimethylammonium bromide solution, and 0.2% benzalkonium bromide solution were all ≥5 on days 0 and 7. The log reduction values of opened 75% ethanol were ≥5 on days 0 and 7 and at 1, 2, and 3 months after opening. All disinfectants were therefore qualified and effective. Compared with the factory inspection data, the nutritional components, chemical contaminants, and microbial indicators of SPF-grade rat and mouse maintenance feed, SPF-grade guinea pig growth and reproduction feed, conventional-grade guinea pig growth and reproduction feed, rabbit maintenance feed, and dog maintenance feed showed a slight overall downward trend but no significant differences 7 days after opening. 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 sterilization showed no significant fluctuations. All indicators still met the relevant requirements of GB/T 14924.2—2001 Laboratory Animals—Hygienic Standard for Formula Feeds and GB 14924.3—2010 Laboratory Animals—Nutrients for Formula Feeds. Conclusion Based on practical experience in managing the center's GLP laboratory animal facility and validation of core quality indicators, the specified validity periods of disinfectants, feed, and bedding meet the quality requirements, providing a practical reference for the standardized management of laboratory animal facilities.

Key words: Good Laboratory Practice (GLP), Disinfectant, Feed, Bedding, Validity period, Material management, Laboratory animal

CLC Number:

Q95-33
R187

MA Wenjing,LIU Yanping,LI Yifan,et al. Practice in Validity Period Management of Disinfectants, Feed, and Bedding in Laboratory Animal Facilities under Good Laboratory Practice Management System[J]. Laboratory Animal and Comparative Medicine, 2026, 46(4): 593-603. DOI: 10.12300/j.issn.1674-5817.2025.162.

Figures/Tables 6

References 22

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消毒剂 Disinfectants	存放周期 Storage period	反应管作用后残存活菌浓度/（CFU·mL^-1） Viable bacterial concentration in reaction tubes after exposure/(CFU·mL^-1)	实测杀灭对数值 Measured log reduction value	可接受标准 Acceptable standards	是否合格 Qualified
0.04%次氯酸钠溶液 0.04% Sodium hypochlorite solution	消毒剂存放第0天	25.000	6.300	杀灭对数值≥5.000	合格
0.04%次氯酸钠溶液 0.04% Sodium hypochlorite solution	消毒剂存放第7天	55.000	5.930	杀灭对数值≥5.000	合格
0.1%癸甲溴铵溶液 0.1% Didecyldimethylammonium bromide solution	消毒剂存放第0天	10.000	6.700	杀灭对数值≥5.000	合格
0.1%癸甲溴铵溶液 0.1% Didecyldimethylammonium bromide solution	消毒剂存放第7天	60.000	5.890	杀灭对数值≥5.000	合格
0.2%苯扎溴铵溶液 0.2% Benzalkonium bromide solution	消毒剂存放第0天	40.000	6.100	杀灭对数值≥5.000	合格
0.2%苯扎溴铵溶液 0.2% Benzalkonium bromide solution	消毒剂存放第7天	80.000	5.770	杀灭对数值≥5.000	合格
阳性对照 Positive control	消毒剂存放第0天	5.000×10⁷	—		—
阳性对照 Positive control	消毒剂存放第7天	4.700×10⁷	—		—

消毒剂 Disinfectants	存放周期 Storage period	反应管作用后残存活菌浓度/（CFU·mL^-1） Viable bacterial concentration in reaction tubes after exposure/(CFU·mL^-1)	实测杀灭对数值 Measured log reduction value	可接受标准 Acceptable standards	是否合格 Qualified
0.04%次氯酸钠溶液 0.04% Sodium hypochlorite solution	消毒剂存放第0天	25.000	6.300	杀灭对数值≥5.000	合格
0.04%次氯酸钠溶液 0.04% Sodium hypochlorite solution	消毒剂存放第7天	55.000	5.930	杀灭对数值≥5.000	合格
0.1%癸甲溴铵溶液 0.1% Didecyldimethylammonium bromide solution	消毒剂存放第0天	10.000	6.700	杀灭对数值≥5.000	合格
0.1%癸甲溴铵溶液 0.1% Didecyldimethylammonium bromide solution	消毒剂存放第7天	60.000	5.890	杀灭对数值≥5.000	合格
0.2%苯扎溴铵溶液 0.2% Benzalkonium bromide solution	消毒剂存放第0天	40.000	6.100	杀灭对数值≥5.000	合格
0.2%苯扎溴铵溶液 0.2% Benzalkonium bromide solution	消毒剂存放第7天	80.000	5.770	杀灭对数值≥5.000	合格
阳性对照 Positive control	消毒剂存放第0天	5.000×10⁷	—		—
阳性对照 Positive control	消毒剂存放第7天	4.700×10⁷	—		—

消毒剂 Disinfectants	存放周期 Storage period	反应管作用后残存活菌浓度/（CFU·mL^-1） Viable bacterial concentration in reaction tubes after exposure/(CFU·mL^-1)	实测杀灭对数值 Measured log reduction value	可接受标准 Acceptable standards	是否合格 Qualified
75%乙醇 75% Ethanol	第0天	85.000	5.770	杀灭对数值≥5.00	合格
75%乙醇（1号喷壶） 75% Ethanol (Spray bottle No.1)	第7天	85.000	5.740	杀灭对数值≥5.00	合格
	第1个月	45.000	5.710	杀灭对数值≥5.00	合格
	第2个月	未检出	≥7.280	杀灭对数值≥5.00	合格
	第3个月	55.000	5.370	杀灭对数值≥5.00	合格
75%乙醇（2号喷壶） 75% Ethanol (Spray bottle No.2)	第7天	50.000	5.970	杀灭对数值≥5.00	合格
	第1个月	60.000	5.580	杀灭对数值≥5.00	合格
	第2个月	45.000	5.630	杀灭对数值≥5.00	合格
	第3个月	未检出	≥7.110	杀灭对数值≥5.00	合格
75%乙醇（3号喷雾器） 75% Ethanol (Sprayer No.3)	第7天	60.000	5.890	杀灭对数值≥5.00	合格
	第1个月	80.000	5.460	杀灭对数值≥5.00	合格
	第2个月	70.000	5.440	杀灭对数值≥5.00	合格
	第3个月	50.000	5.410	杀灭对数值≥5.00	合格
阳性对照 Positive control	第0天	5.000×10⁷	-		-
	第7天	4.700×10⁷	-		-
	第1个月	2.300×10⁷	-		-
	第2个月	1.920×10⁷	-		-
	第3个月	1.280×10⁷	-		-

消毒剂 Disinfectants	存放周期 Storage period	反应管作用后残存活菌浓度/（CFU·mL^-1） Viable bacterial concentration in reaction tubes after exposure/(CFU·mL^-1)	实测杀灭对数值 Measured log reduction value	可接受标准 Acceptable standards	是否合格 Qualified
75%乙醇 75% Ethanol	第0天	85.000	5.770	杀灭对数值≥5.00	合格
75%乙醇（1号喷壶） 75% Ethanol (Spray bottle No.1)	第7天	85.000	5.740	杀灭对数值≥5.00	合格
	第1个月	45.000	5.710	杀灭对数值≥5.00	合格
	第2个月	未检出	≥7.280	杀灭对数值≥5.00	合格
	第3个月	55.000	5.370	杀灭对数值≥5.00	合格
75%乙醇（2号喷壶） 75% Ethanol (Spray bottle No.2)	第7天	50.000	5.970	杀灭对数值≥5.00	合格
	第1个月	60.000	5.580	杀灭对数值≥5.00	合格
	第2个月	45.000	5.630	杀灭对数值≥5.00	合格
	第3个月	未检出	≥7.110	杀灭对数值≥5.00	合格
75%乙醇（3号喷雾器） 75% Ethanol (Sprayer No.3)	第7天	60.000	5.890	杀灭对数值≥5.00	合格
	第1个月	80.000	5.460	杀灭对数值≥5.00	合格
	第2个月	70.000	5.440	杀灭对数值≥5.00	合格
	第3个月	50.000	5.410	杀灭对数值≥5.00	合格
阳性对照 Positive control	第0天	5.000×10⁷	-		-
	第7天	4.700×10⁷	-		-
	第1个月	2.300×10⁷	-		-
	第2个月	1.920×10⁷	-		-
	第3个月	1.280×10⁷	-		-

饲料种类 Feed type	指标 Indicator	营养成分 Nutritional ingredients
饲料种类 Feed type	指标 Indicator	水分 Moisture	粗蛋白 Crude protein	粗脂肪 Crude fat	粗纤维 Crude fiber	粗灰分 Crude ash	钙 Ca	磷 P
普通级豚鼠生长繁殖饲料 Conventional-grade guinea pig growth and reproduction feed	规定值	≤110.000	≥170.000	≥30.000	100.000～150.000	≤90.000	10.000～15.000	5.000～8.000
	出厂值	56.000	224.200	42.000	137.000	80.000	13.600	7.800
	检测值	104.000	192.300	33.000	101.000	83.000	14.900	7.600
	是否符合	是	是	是	是	是	是	是
兔维持饲料 Rabbit maintenance feed	规定值	≤110.000	≥140.000	≥30.000	100.000～150.000	≤90.000	10.000～15.000	5.000～8.000
	出厂值	105.000	141.000	41.000	148.000	85.000	12.900	7.700
	检测值	75.000	149.500	34.000	137.000	85.000	12.500	6.400
	是否符合	是	是	是	是	是	是	是
犬维持饲料 Dog maintenance feed	规定值	≤100.000	≥200.000	≥45.000	≤40.000	≤90.000	7.000～10.000	5.000～8.000
	出厂值	88.000	206.800	94.000	28.000	46.000	7.560	6.200
	检测值	69.000	209.100	88.000	18.000	48.000	9.890	7.100
	是否符合	是	是	是	是	是	是	是
SPF级大小鼠维持饲料 SPF-grade rat and mouse maintenance feed	规定值	≤100.000	≥180.000	≥40.000	≤50.000	≤80.000	10.000～18.000	6.000～12.000
	出厂值	14.000	221.100	62.000	42.000	66.000	12.600	7.600
	检测值	82.000	184.900	43.000	33.000	68.000	14.900	8.900
	是否符合	是	是	是	是	是	是	是
SPF级豚鼠生长繁殖饲料 SPF-grade guinea pig growth and reproduction feed	规定值	≤110.000	≥170.000	≥30.000	100.000～150.000	≤90.000	10.000～15.000	5.000～8.000
	出厂值	93.000	201.000	41.000	107.000	86.000	14.800	8.000
	检测值	104.000	201.700	39.000	101.000	82.000	14.800	7.600
	是否符合	是	是	是	是	是	是	是