溶媒结晶型无菌原料药车间布局要点与典型工艺技术

Key Points in Disposition for Sterile Menstruum-crystallization Active-pharmaceutical-ingredient Workshop and Typical Process Technology

针对生产过程使用易燃易爆溶媒和大宗固体物料输送的特性,结合国家相关设计规范,分析了在进行溶媒结晶型无菌原料药车间设计时需要重点考虑的布局要点;对近年来无菌原料药生产过程出现的几种典型技术进行了阐述和总结,并指出新技术的发展方向。

Based on the fact that in production flammable menstruum is used and with respect to the features of transportation for large amount of solid material, and also combined with relevant design code, the key points in disposition of sterile menstruun-crystallization active-pharmaceutical-ingredient workshop was analyzed in this article. Several typical technologies, which has appeared in recent years, used in the production of sterile active-pharmaceutical-ingredient were described and summarized, and the trend of new technology development was forecasted.