重组蛋白疫苗原液中试车间工艺布局设计及案例分析

Process Layout Design and Case Analysis of Pilot Plant for Recombinant Protein Vaccine Stock Solution

针对重组蛋白疫苗原液生产工艺特性,结合GMP和国家相关法规要求,为满足原液中试车间多产品共线、多品种生产的特殊性,对重组蛋白疫苗原液的生产工艺流程、车间工艺布局进行设计分析。结合实际案例,从平面布局、人流设计、物流设计、污物流设计、空调分区几个方面来阐述重组蛋白疫苗原液中试车间的工艺布局设计思路。满足中试车间对不同产品、不同工艺流程的需求,同时符合各专业设计规范,综合各方面的要求才能得到最适宜的设计方案。

According to the production process characteristics of stock solution of recombinant protein vaccine,combined with GMP and other relative national regulations,in order to meet the particularity of multi-product common line and multi-variety production in the pilot plant of the stock solution,the production process flow and workshop layout of stock solution of recombinant protein vaccine were designed and analyzed.Combined with the actual case,the process layout design of pilot plant for stock solution of recombinant protein vaccine was described from the aspects of plane layout,people stream design,goods flow design,sewage flow design and air conditioning division.To meet the pilot plant for different products,different process requirements,and meet the professional design specifications,comprehensive requirements of all aspects to get the most appropriate design scheme.