新冠疫苗原液车间建设关键点分析

作者：杨九祥陶刚于承志

单位：中国电子系统工程第二建设有限公司中国食品药品检定研究院

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。

关键词：新冠疫苗原液车间防护区边界围护结构严密性工况转换压差控制

作者简介：杨九祥，男，1982年生，大学，高级工程师，副总工程师;*于承志（通信作者）102600北京市大兴区生物医药基地华佗路31号,E-mail:ycz2001@126.com;

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参考文献[1] World Health Organization.Novel coronavirus (COVID-19) situation[EB/OL].[2022-09-26].https://covid19.who.int/.

[2] 国家卫生健康委办公厅.关于印发疫苗生产车间生物安全通用要求的通知(国卫办科教函[2020]483号)[EB/OL].(2020-06-18)[2022-09-26].http://www.nhc.gov.cn/qjjys/s7948/202006/391e704a045944999 c565907f16ed579.shtml.

[3] 中国建筑科学研究院.生物安全实验室建筑技术规范：GB 50346—2011[S].北京：中国建筑工业出版社，2012:4-7.

[4] 杨九祥，梁忠峥，徐义强，等.一种带有生物安全柜的高等级生物安全实验室排风系统：CN212370788U[P].2021-01-19.

[5] 杨建建，杨九祥，李佳明，等.一种实验室非人灵长类动物实验室排风系统：CN217402755U[P].2022-09-09.

[6] 杨九祥.实验动物设施屏障环境设计与建造要点[J].洁净与空调技术，2021(4):92-96.

Analysis of construction key points of COVID-19 vaccine bulk solution workshops

Yang Jiuxiang Tao Gang Yu Chengzhi

(China Electronics System Engineering No.2 Construction Co., Ltd. National Institutes for Food and Drug Control)

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;

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