运用吹灌封技术的滴眼剂车间工艺设计探讨

Design of Eye drops facility by Blow-Fill-Seal technology

结合多年外资公司无菌药品车间工程设计经验和曾经参与设计的某滴眼剂的实践来探讨吹灌封技术的滴眼剂车间的工艺工程设计。吹灌封设备的选型和布置是车间设计的核心,但无菌滴眼剂药液的配制、除菌、输送以及无菌塑料安瓿的检漏都是无菌保证的重要环节。根据滴眼剂和吹灌封技术两个不同于其它无菌药品的特点从各个方面同时来探讨车间的工艺设计。

Combined with years of practical experience in international pharmaceutical engineering company and real cases of international cGMP compliance facility for eye drops by Blow-Fill-Seal technology, in this paper, it was indicated that selection of BFS equipment and its layout are core considerations for this kind of design, but there are also other steps for assurance of sterile, such as compound of eye drops, sterilization, transportation and examination of plastic bottle. Design of facility was discussed then from all aspects based on two characteristics of both of BFS and Eye Drops.