马文静 1刘燕萍 1李一帆 1郭欢 1谢理惠 1杜龙基 1马佳丽 1王红平 1黎家敏1
作者信息
- 1. 四川省药品检验研究院(四川省医疗器械检测中心、四川养麝研究所)安全评价中心,成都 611731||国家药品监督管理局监管科学创新研究基地,成都 611731
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摘要
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.关键词
良好实验室规范/消毒剂/饲料/垫料/有效期/物料管理/实验动物Key words
Good Laboratory Practice(GLP)/Disinfectant/Feed/Bedding/Validity period/Material management/Laboratory animal分类
生物科学
