大学毕业设计轧盖工艺选择对多品种重组蛋白质药物无菌车间布局的影响.doc

摘 要 研究背景：特宝生物公司拟采用模块化的布局理念，?在一个复合的制剂车间中整合西林瓶注射液/冻干粉针和预充注射器注射液两条无菌生产线，为10个左右的重组蛋白质药物提供规范、高效、低成本的制剂生产车间。同时这些产品还要销往中国以外的亚洲、美洲、欧洲和非洲等地区，面临多个国家和地区的法规监管要求，因此需要依据最新的GMP发展趋势，按无菌风险和对产品质量影响程度，重点构思和梳理工艺布局，找到优化的方案，并对关键风险环节进行针对性处理。 研究过程：通过法规评价和产品分析，找到影响车间布局的关键因素为产品特性和工艺流程。而对于紧凑型多生产线的布局，轧盖区域的选择和布局是欧盟和中国GMP法规关注的焦点之一。通过对3种典型布局的物料流程和人员流程以及无菌风险控制进行了分析，选择了比较严格的车间布局。对于影响无菌车间布局的轧盖工艺设计，采用了B的方案，设计了正压保护的捕尘系统，最大程度减少空间需求和投资和运行管理成本。 研究结论：多品种重组蛋白质药物制剂生产车间两条无菌生产线的设计、安装和验证符合“质量源于设计”和“质量风险管理”等最新的GMP理念，投产后产能可以达到3000多万支的目标。 ? 关键词：重组蛋白质药物；无菌轧盖；RABS；正压捕尘系统 The Choice of Sealing Machine and the Influence for the Aseptic Facilities Layout of Multi Recombinant Protein Drugs Abstract Research Background: Amoytop Biotech?company adopts modular concept to design the layout for an aseptic multi-products preparation facility, which integrates two aseptic filling lines for about ten recombinant protein drugs, including the vial injection/freeze-dried product and the prefilled syringe injection, into one facility, to provide a preparation workshop with compliance, high efficiency and low cost.?As these products will be marketed to other regions, such as Asia, America, Europe and Africa, besides China, it is inevitable that the regulatory requirements of other countries and regions will be taken into consideration. On the basis of the latest cGMP requirement, according to the aseptic risk level and the impact to the product’s quality, Amoytop focuses on the design and arrangement of process layout, optimizes the scheme, and adopts the strategy aiming at the key risk elements. Research Process: Through the regulations evaluation and product analysis, the product characteristics and process are found to be the key factors which might influence workshop layout. For the compact production line layout, the selection and layout of aseptic sealing region is one of the concerns of European Union and Chinese GMP regulations. Through analyzing three typical layouts of the material flow, personnel flow and aseptic ris