单克隆抗体药物在医药洁净厂房的设计要点分析

Analysis of Design Points of Pharmaceutical Clean Workshop for Producing Monoclonal Antibody Drugs

分析单克隆抗体药物在医药洁净厂房的设计。参照国家与国际相关法规,根据单克隆抗体生产工艺,结合相关单克隆抗体设计案例,对单克隆抗体生产工序及设计理念进行阐述。详细分析单克隆抗体药物的制备流程、污染源、人物流、空调系统、废水灭活等设计要点。该设计理念符合GMP设计理念,同时满足节约能耗,降低运行成本的目的。

The design of pharmaceutical clean workshop for producing monoclonal antibody drugs was analyzed.Referring to relevant national and international regulations,according to the monoclonal antibody production process,combined with relevant monoclonal antibody design cases,the monoclonal antibody production process and design concept were described.The preparation process,pollution sources,human flow,air conditioning system,wastewater inactivation and other design points of monoclonal antibody drugs were analyzed in detail.The design concept conformed to the GMP design concept,and met the purpose of saving energy consumption and reducing operating costs.