中国医学装备2018，Vol.15Issue(6)：39-42,4.DOI:10.3969/J.ISSN.1672-8270.2018.06.012
冻干机性能验证方法的建立和应用
Establishment and application of verification method about the performance of freeze dryer
魏荣华 1周茂德 1何申柔 1原结梅1
作者信息
- 1. 广州白云山拜迪生物医药有限公司 广东 广州 511495
- 折叠
摘要
Abstract
Objective: To establish a verification method about the performance of vacuum freeze dryer and verify the performance of LYOTK5 type vacuum freeze dryer. Methods: In strict accordance with the requirements of GMP (2010 version), this research verified the performance of the freeze dryer in evacuation velocity of pump, CIP/SIP and temperature homogeneity of ply, and verified whether the performance of freeze dryer could meet the process requirements of products. Results: The results showed that evacuation velocity of pump could meet the requirement that the vacuumized time was less than 40 min when the vacuum degree decreased below 25 Pa. And the coverage rate of online cleaning was 100%, and online sterilization was entire, and F0of each temperature point was higher than 15 min. Besides, when homogeneity temperatures of ply were kept at -40℃, 0℃ and 40℃, the temperature difference between maximum and minimum value of all test point of each ply at the same time was lower than 2℃. Conclusion:The each performance of the used freeze dryer can meet the production requirements through verification of testing.关键词
冻干机/性能验证/真空/在线CIP/SIP/温度均匀性Key words
Freeze dryer/Performance verification/Vacuum/CIP and SIP/Temperature homogeneity分类
医药卫生引用本文复制引用
魏荣华,周茂德,何申柔,原结梅..冻干机性能验证方法的建立和应用[J].中国医学装备,2018,15(6):39-42,4.
