摘要
86℃低温冰箱是用于保存疫苗生产中关键菌毒种和生物样本活性的关键设备,低温冰箱的运行状态和性能直接关系到生物制品质量,是工艺生产的核心要素。为保证低温冰箱满足菌毒种保存的要求,本文根据中国2010版GMP对保存菌毒种用低温冰箱性能验证方案进行了设计和实施,性能验证包括设计确认、安装确认、运行确认和性能确认。验证结果证实了验证方案的有效性,可确保低温冰箱在使用过程中能够完全满足储藏条件且安全可靠,可为菌毒种保藏提供有效保障。
The-86℃low-temperature refrigerator is a key equipment used to preserve the key bacterial strains and biological samples activity in vaccine production.The running state and performance of the low-temperature refrigerator are directly related to the quality of biological products and are the core elements of the process production.To meet the requirements of design and the standards of GMP China 2010 on bacteria and virus preservation,we made a verification proposal which covered perspectives of design,installation,operation and performance to verify the performance of low temperature refrigerator on preserving bacteria and virus.The validation result confirms the validity of the validation scheme,ensuring that the validation scheme is drafted from four aspects and a complete report is issued to confirm that the cryogenic refrigerator can fully meet the storage conditions and is safe and reliable in the process of use,which can provide an effective guarantee for the preservation of bacteria and virus preservation.
出处
《计量与测试技术》
2019年第12期7-10,共4页
Metrology & Measurement Technique
关键词
低温冰箱
生物制品
验证
GMP
low temperature refrigerator
biological Products
verification
GMP
