多品种口服固体制剂车间设计探讨

Discussion on Design of Multi-variety Oral Solid Preparations Workshop

固体制剂是中国制药生产中的普遍剂型,其生产车间设计过程中,除了要考虑不同生产区域划分、人物流走向等问题外,对于生产中产生的粉尘污染还要有必要的防护措施。文章以片剂、胶囊剂和颗粒剂固体制剂生产车间为例,依据GMP和国家关于建筑、消防、环保、能源等方面的规范,设计满足多品种同时生产的制剂车间,设计过程中遵循安全性、可靠性、规范性,力争做到观念新颖、设备先进、以人为本的特点,通过对工艺流程、车间布置和人物流走向的探讨,为现代口服固体制剂车间设计提供借鉴。

Solid preparations are common dosage forms in pharmaceutical production in China.In the design process of production workshop,besides considering the division of different production areas and the trend of people flow,it is necessary to take preventive measures against dust pollution in production.Taking the production workshop of tablets,capsules and granules as an example,according to GMP and the national standards on construction,fire protection,environmental protection and energy,this paper designs a preparation workshop which meets the requirements of multi-variety simultaneous production.In the design process,it follows safety,reliability and standardization,and strives to achieve the characteristics of novel concept,advanced equipment and people-oriented.Through the process flow,the preparation workshop can meet the requirements of multi-variety simultaneous production.The discussion of workshop layout and the trend of human logistics can provide reference for the design of modern oral solid preparation workshop.