生物制品分装过程中高效蓄冷剂保温效果验证.pdfVIP

学术论著 中国医学装备2010年12月第7卷第12期 China Medical Equipment 2010 December Vol.7 NO.12 生物制品分装过程中高效蓄冷剂保温效果验证 ① ① ① 蒋井明 彭晓蓉 王文瑞 [文章编号] 1672-8270(2010)12-0006-05 [中图分类号] R 392 [文献标识码] B [摘要] 为了满足活疫苗及其他对温度敏感的制品在分装过程中半成品2～8℃放置的要 求，按照2010年版《药典》三部中生物制品分装和冻干要求，以高效蓄冷剂保温半成 品容器，以分装规格为0.5ml/瓶，分装量125ml/分钟的速度进行注射用水的分装，每 间隔一定时间进行注射用水的温度检测，验证结果确认了该方法能满足分装生产的要 求，同时为对有温度要求的分装生产提供了一套新的验证方法。 [关键词] 分装；温度要求；高效蓄冷剂；验证 Appraisal of temperature-keeping effect of high-efficiency cooling reagent during split charging of biological products/JIANG Jing-ming, PENG Xiao- 作者简介 rong, WANG Wen-rui// China Medical Equipment,2010,7(12):6-10. 蒋井明,男,(1968- ),高 [Abstract] To meet the requirement of store final bulk of live vaccine or other 级工程师。兰州生物制 ～ ℃ 品研究所，从事生物制 temperature sensitive biological products at 2 8 , we kept the temperature of container for final bulk with high efficiency cooling reagent and filled WFI, 0.5ml 品的分包装生产管理工 pervial, 125ml per minute according to the requirement of Chinese pharmacopeia 作。 (2010, version III). The temperature of WFI was checked periodically and the validation result of which showed that the method is acceptable and is a new validation method of filling biological product with temperature required. [Key words] Filling; Temperature requirement; High efficiency cooling reagent; Validation [First-authors address] Lanzhou Institute of Biological Products, Lanzhou 730046, China. ①兰州生物制品研究所 甘肃 兰州 730046 [5] 郭爱民,王亚东,李春雨，等.全国社区卫 参考文献 生服务现状调查一采用秩和比法评价我国 [1] Winslow CE. Man and epidemics. 社区卫生服务站的服务功能[J].中国全科医 Princeto