呼吸袋在非最终灭菌制剂的胶塞无菌转运过程中的应用  

Application of Clean Flex~? Sterilizable Bags for Sterile Halogenated Butyl Rubber Stopper Delivery in Preparation of Non Terminal Sterilized Formulation

作　　者：刘晓宇 勾洋梅 张安山 张金 才辉 刘晓 

机构地区：[1]兰州兰生血液制品公司,甘肃兰州730046

出　　处：《中国医药工业杂志》2017年第9期1373-1376,共4页Chinese Journal of Pharmaceuticals

摘　　要：本试验探讨在非最终灭菌大容量注射剂生产的洁净室内,呼吸袋在胶塞转移过程中的应用,以最大限度减少灭菌后的胶塞在转移及使用过程中遭受异物污染的风险,同时考察运用呼吸袋转移胶塞对制品外观可见异物不合格率的影响。分别选取未使用和使用呼吸袋,以及改进呼吸袋使用方式后分装的制品A与制品B,比较不同胶塞转移方式生产的制品中可见异物不合格瓶数。统计结果显示,使用热合封口的呼吸袋较未使用呼吸袋进行胶塞转移分装的制品中可见异物不合格瓶数显著上升。通过注射用水冲洗呼吸袋内表面、并改用不锈钢夹封口后,分装的制品中不合格瓶数较未使用呼吸袋显著降低(P<0.05)。上述结果表明,将洁净胶塞装入注射用水冲洗过的呼吸袋中,利用不锈钢夹封口,再放入带孔的不锈钢盒内高压灭菌,可以实现胶塞转移过程中的隔离保护,降低异物污染的风险,同时不会额外升高制品外观中可见异物的不合格数。This work explored two different sealing ways of ultraclean clean steam bags （CleanFlex sterilizable bags） for transferring halogenated butyl rubber stoppers in the clean room where produces large volume injections. Compared with traditional heating sealing way, sealing with stainless steel clip was more efficient in reducing the risk of contamination from foreign matters in the course of transfer and use, and reducing the products＇ unqualified rates in visible particles. Unqualified bottles in visible particles of products A and B were compared respectively, which were produced with heating or stainless steel clip sealed CleanFlex sterilizable bags, as well as without bags for sterile stoppers＇ delivery, to investigate the influences of delivery ways on the visible particles of both products. Statistical results showed that, compared with those without the usage of sterilizable bags, the quantity of unqualified bottles increased significantly if using heating sealed CleanFlex sterilizable bags, while it significantly decreased when the inner surface of CleanFlex sterilizable bags with WFI was washed and sealed with stainless steel clips. As a result, we can conclude that arranged, the stoppers in rinsed CleanFlex sterilizable bags which was sealed with stainless steel clips, then laid them in stainless steel boxes with holes for sterilization, could forms isolated protection for decreasing the risk of contamination in the process of stoppers＇ delivery without increasing extra unqualified products in visible particles.

关 键 词：超净清洁蒸汽袋 药用卤化丁基橡胶塞 无菌转移 

分 类 号：TQ460.63[化学工程—制药化工]