药用真空冷冻干燥机校准方法研究  

Research on Calibration Method of Pharmaceutical Vacuum Freeze Dryer

作　　者：赵晶[1] 张海锭[1] 万正军 魏嵬 许澍[3] 常稼强 王宇航 陈守彬 ZHAO Jin;ZHANG Haiding;WAN Zhengjun;WEI Wei;XU Shu;CHANG Jiaqiang;WANG Yuhang;CHEN Shoubin

机构地区：[1]中国测试技术研究院 [2]重庆誉颜制药有限公司 [3]云南省计量测试技术研究院 [4]成都市计量检定测试院 [5]吉林省计量科学研究院 [6]江苏瑞科生物技术股份有限公司

出　　处：《计量与测试技术》2023年第10期80-83,共4页Metrology & Measurement Technique

基　　金：四川省重要技术标准研究项目(项目编号:ZYBZ2022-14)。

摘　　要：为了满足药用真空冷冻干燥机量值溯源的计量需求,针对我国目前不具备药用真空冷冻干燥机的国家和地方校准方法的现状,采用无线温度、真空记录器进行药用真空冷冻干燥机温度和真空度参数的校准方法研究和实验验证。实验表明:该校准方法能客观准确、全面系统地评价设备的性能,保证产品的质量,为生物医药产业的研发,工艺参数优化改进提供计量技术支撑。In order to meet the demand for traceability measurement of pharmaceutical vacuum freeze dryer,be aimed at the current situation that pharmaceutical vacuum freeze dryer do not have calibration methods,wireless temperature and vacuum recorders are used to study and experimentally verify the calibration methods for tempera-ture and vacuum parameters of pharmaceutical vacuum freeze dryer.Experiment results have shown that the calibra-tion method can objectively,accurately,and comprehensively evaluate the performance of equipment,ensure prod-uct quality,and provide metrological technical support for the research and development of the biopharmaceutical industry,as well as the optimization and improvement of process parameters.

关 键 词：真空冷冻干燥 温度 真空度 校准方法 

分 类 号：TQ460.5[化学工程—制药化工]