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。 In view of the characteristics of the production process using flammable and explosive solvents and bulk solid materials transportation, combined with the relevant national design specifications, analysis of the layout of the key points to be considered in the design of the solvent-crystalline sterile APIs workshop; The emergence of several typical techniques of drug production were described and summarized, and pointed out that the development of new technologies.