新冠疫苗原液车间建设关键点分析
Analysis of construction key points of COVID-19 vaccine bulk solution workshops
摘要:
提出了新冠疫苗原液车间“生物安全+GMP”双重属性要求的概念。介绍了防护区边界确定、围护结构严密性、防护区工况转换压差控制等项目实施核心技术难题。分析了平面优化设计方案、围护结构严密性技术和防护区工况转换压差控制技术三大核心技术及其在新冠疫苗原液车间建设中的应用。
Abstract:
This paper puts forward the concept of “biosafety+GMP” dual attribute requirements of COVID-19 vaccine bulk solution workshops, presents the core technical problems of project implementation, such as the boundary definition of the containment area, the air-tightness of the building envelope, and the differential pressure control of the working condition switch in the containment area, and analyses the applications of the three core technologies in the construction of COVID-19 vaccine bulk solution workshops, such as the layout optimization design scheme, envelope air tightness technology and differential pressure control technology for working condition switch in the containment area.
Keywords:COVID-19 vaccine; bulk solution workshop; boundary of containment area; envelope; air-tightness; working condition switch; differential pressure control