非无菌原料药拉西地平和阿奇沙坦的车间设计探讨  

Discussion on Non-sterile API Lacidipine and Azilsartan Workshop Design

作　　者：董继红[1] 李占印[1] 祁刚[1] 汤宇纯 Dong Jihong(Yancheng Institute of Technology,Yancheng 224051)

机构地区：[1]盐城工学院,盐城224051

出　　处：《化工设计》2018年第2期39-42,52,共5页Chemical Engineering Design

摘　　要：本文依据25t/a非无菌原料药拉西地平及阿奇沙坦生产的物料衡算和主要设备选型结果,探讨了拉西地平及阿奇沙坦生产的车间设计过程。车间整体设计为长方形,三层厂房,满足通风、采光、防火防爆的相关要求。洁净区用于原料药产品的结晶干燥、粉碎、检验和内包等,按照D级洁净区的标准进行设计。依据GMP和建筑设计防火等规范,对一般生产区、辅助生产区和洁净区进行设计。According to the raw material balance and the results of major equipment selection of the 25 t/a non-sterile API lacidipine and azilsartan production material,this paper explores the workshop design process of lacidipine and azilsartan production plant.The overall design of the workshop is rectangular and three一storey workshop,which can meet the related requirements of ventilation,lighting,fire and explosion prevention.The clean area is used for the crystallization,drying,crushing,inspection and internal packing of the raw material medicine products,and is designed accordingto the standard of gradeD clean area.According to GMPand architectural design specifications for fire prevention,the general production area,auxiliary production areas and clean areas are specifically designed.

关 键 词：非无菌原料药 拉西地平 阿奇沙坦 车间设计 

分 类 号：TQ460.8[化学工程—制药化工]