摘要
在满足GMP(2010年修订)和相关设计规范的前提下,结合具体设计案例和工程实践经验,针对水痘减毒活疫苗原液生产的工艺特性,从生产工艺流程、工艺布置和生物安全三个方面对水痘减毒活疫苗原液生产车间的工艺设计进行总结分析,以提供现代化、高标准的水痘减毒活疫苗原液生产车间的工艺设计方案。
Under the preconditions to meet the requirements in GMP and relevant design codes,combined with practical design examples and engineering experiences,and with respect to the characteristics of varicella attenuated live vaccine production,the design of process for bulk production workshop for varicella attenuated live vaccine was analyzed and summarized from three aspects of production procedure,process arrangement and biological safety,from which modern and high standardized process design scheme had been provided.
作者
张瑞超
张晓彤
Zhang Ruichao;Zhang Xiaotong(China Aviation Planning and Design Institute(Group)Co.,Ltd,Beijing 100120)
出处
《化工与医药工程》
2020年第2期34-37,共4页
Chemical and Pharmaceutical Engineering
关键词
水痘减毒活疫苗
原液生产
工艺设计
GMP
varicella attenuated live vaccine
bulk production
process design
GMP
