药品冷库的温度分布特性研究  

Temperature Distribution Characteristics of Walk-In Refrigerator for Drug Storage

作　　者：张丽丽 江志杰 宣泽 ZHANG Lili;JIANG Zhijie;XUAN Ze(Beijing Institute for Drug Control·NMPA Key Laboratory for Research and Evaluation of Generic Drugs·Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing,China 102206)

机构地区：[1]北京市药品检验研究院·国家药品监督管理局仿制药研究与评价重点实验室·中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国药业》2023年第15期59-62,共4页China Pharmaceuticals

摘　　要：目的通过热分布试验,确认冷库是否符合使用要求,为药品的安全冷藏提供依据。方法参照《药品经营质量管理规范》《医药产品冷链物流温控设施设备验证性能确认技术规范》GB/T 34399—2017技术要求,将记录型无线温度探头放置在冷库的不同储藏位置进行温度分布测试、开门测试和断电测试。结果冷库各个测试位置的温度始终保持在3.7~7.0℃,温度均匀度为0.7℃,温度波动度为0.4℃,温度偏差为-2.5~1.5℃。开门4 min后和断电1 h 28 min后达到温度警戒值。结论药品存储的冷库性能正常,温度能满足疫苗等冷藏样品的存储要求。Objective To confirm whether walk-in refrigerator meets its use requirements through test thermal analysis,and to provide a basis for the safe cold storage of drugs.Methods According to the technical requirements of Good Supply Practice and Temperature Control Facilities of Pharmaceutical Products Cold Chain Logistics-Specification for Performance Qualification(GB/T 34399-2017),the recording wireless temperature probe was placed in different storage positions of walk-in refrigerator for temperature distribution test,door opening test and power-off test.Results The temperature of walk-in refrigerator was always kept in the range of 3.7-7.0℃,with a temperature uniformity of 0.7℃,a temperature fluctuation of 0.4℃,and a temperature deviation of-2.5-1.5℃.The temperature reached temperature warning value after 4 min of opening door and 1 h 28 min of power failure.Conclusion The performance of the walk-in refrigerator for drug storage is normal,and the temperature can meet the storage requirements for vaccines and other refrigerated samples.

关 键 词：冷藏药品 冷库 温度 开门试验 断电试验 

分 类 号：R954[医药卫生—药学]