冻干原料车间的设计体会

Experience on the Design of Freeze-drying Raw Material Workshop

新版医药工业洁净厂设计标准于2019年12月实施,结合正在进行的无菌头孢冻干原料药改造项目,对新规范变动的条文对设计工作影响和旧车间改造过程中遇到的问题进行了分析,提出了设计项目运行过程需要把握的环节,提高了设计质量和进度。

The new version of pharmaceutical industry clean plant design standard and its implementation in December 2019,the author combined with the ongoing aseptic cephalosporin freeze-drying API transformation project,analyzed the impact of the provisions of the new specification changes on the design work and the problems encountered in the transformation process of the old workshop, proposed the links to be grasped in the operation process of the design project,and improved the design quality and progress.