非无菌原料药拉西地平及阿奇沙坦的车间设计

Workshop Design of Non-sterile API Lacidipine and Azilsartan

依据非无菌原料药拉西地平和阿奇沙坦生产的物料衡算、热量衡算以及主要设备选型的结果,进行拉西地平和阿奇沙坦生产的车间设计。车间整体设计为T形,厂房设计为双层厂房,满足车间采风、采光、疏散和泄爆的相关要求。一般生产区、洁净区等位于一层,冷冻水间、自来水间、氮气室等位于二层。一般生产区内主要布置反应釜、浓缩釜、脱色釜以及过滤洗涤干燥"三合一"设备等,生产流程不交叉,避免了交叉污染。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,符合新版GMP要求。总平面设计、一般生产区设计、洁净区设计和辅助生产区设计均符合新版GMP要求,在节能、防火和三废排放等方面符合行业规范,从而保障了药品的安全生产。

The workshop design for producing the non-sterile API lacidipine and azilsartan was based on the material balance, the energy balance and the main equipment selection. The double plant and the T-shaped workshop were designed to conform with the requirement of aeration, lighting, evacuation and explosion venting. The general production and clean area were located on the first floor. The frozen water, tap-water and nitrogen supplications were arranged on the second floor. The reactor used for conventional production, concentration and decolorization were placed in the general production area. The equipment used for filter, washing and dry combinably, and other main equipment were also arranged in the general production area. The production processeshad no cross to avoidcontaminationmutually. The clean area designed in accordance with the D-class standard and the new GMP requirement was used for the drying, crushing, inspection and packing of products. The design of total plane, general production area, clean area and the auxiliary production area were all in line with the new GMP requirements. Meanwhile. all designs met the industry standards in energy saving, fire prevention, wastedisposal andother aspects in order to ensure the safety of pharmaceutical production.