小容量注射剂联动生产线布局模式发展趋势

Development Trend of Layout Mode of Production Line for Small Volume Injection Agent

介绍国内小容量注射剂联动线的生产现状与问题,结合新版GMP规范要求和实施案例,阐述L型小容量针剂联动线的技术优势与发展趋势,有效的避免了人流与物流、操作区与维护区之间的交叉污染的可能性,降低了无菌区内悬浮粒子与微生物产生的风险。

Current situation of production line for small volume injection and the problems existed were introduced in this article. Combined with the requirements in new version GMP code and practical examples, the technical advantages of L mode production line for small volume injection and its development trend were stated. By using this production line, the possibility of cross contamination between people flow and matter flow and between operation zone and holding zone can be avoided, and the risk of existence of suspended particle and microbial can be decreased.