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高级别生物安全实验室建设关键问题及应对措施

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为提升高级别生物安全实验室建设管理体系能力,国家编制和发布了一系列法律法规、标准、制度与规划。文章基于实验室建设、使用与运行管理的多重角度,从实验室围护结构建设、设施设备调研与入场、机电安装与调试、科研仪器调研与采购、人员组织架构搭建等方面总结了高级别生物安全实验室建设过程中需要关注的关键问题,并依据工作经验提出可行的应对措施。文章还探讨了实验室从立项到认证流程,以及备案筹备阶段面临的关键问题,以期为高级别生物安全实验室建设管理提供借鉴、参考和思路。
Key issues and countermeasures for constructing high-level biosafety laboratories
[Significance]There are protective measures to be considered by laboratories handling biological agents,and laboratory biosafety protection is divided into four levels.In China,biosafety awareness and extensive cognition have been improved with the large-scale construction of biosafety level 2 laboratories in various places;however,high-level biosafety laboratories(biosafety laboratories with biosafety protection levels 3 and 4)started late,and system construction still needs to be improved.[Progress]In the 1950s and 1960s,the earliest biosafety laboratories were constructed in the United States.In the 1980s,China cooperated with Europe,the United States,Japan,and other countries to build their first batch of high-level biosafety laboratories,and in the 1990s,China began to design and build high-level biosafety laboratories on their own.Currently,many new and renovated projects are still available across the country,and the common problems highlighted in the construction process are worth exploring.[Conclusions and Prospects]To improve and accelerate the construction of high-level biosafety laboratories and the capacity of the national management system,our country has compiled and issued a series of laws,regulations,standards,systems,and plans.From the multiple perspectives of laboratory construction,use,and operation management,this paper summarizes the key problems existing in the construction of high-level biosafety laboratories from the aspects of laboratory envelope construction,facilities and equipment research and admission,mechanical and electrical installation and commissioning,scientific research instruments and procurement,personnel organization,structure construction,and puts forward feasible countermeasures based on work experience.In addition,this paper summarizes,analyzes,and discusses the key issues faced by laboratories in the process from project initiation to certification and the preparation stage for filing to provide references and ideas for other high-level biosafety laboratories.According to the construction process of high-level biosafety laboratories in the past,early intervention of laboratory users has great significance.Laboratory construction is not the manager,and design and construction of building facilities can be completed,such a laboratory is only a building,not in line with the scientific research place.Concise,efficient,and practical are the basic conditions of the laboratory,and a gorgeous appearance is not worth advocating;for example,a very spacious corridor will only compress the space of the core area while increasing construction costs and waste of resources.Users,managers,and facility designers of laboratories must communicate adequately,avoid information asymmetry,and make dynamic adjustments during design and implementation.All personnel involved in the construction must maintain a high sense of responsibility,not cover up problems,and not avoid trouble for the sake of convenience;they should also be open to discussion and inclusive so as to build a good biosafety laboratory.During the preparation period of the laboratory,the personnel can be in place in batches to establish positions including logistics support,project management,experimental technology,facilities and equipment,safety and environmental protection,and human resources.The staffing ratio should be determined according to the concept of laboratory platform construction,the number of auxiliary positions is relatively fixed,and the demand for experimental technical support personnel is large,especially for technical personnel in professional fields.Established high-level biosafety laboratories that have been established should be open to assist in building other laboratories,prevent problems from recurring,and jointly promote biosecurity.Relevant departments need to coordinate efficiently and establish communication platforms.

high-level biosafety laboratorylaboratory constructionbiological safetyresponse measures

薛森仁、郑小奇、张贤宇、李小波、石凤霞、林静雯、韩建保

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四川大学华西医院 生物安全实验室,四川 成都 610041

高级别生物安全实验室 实验室建设 生物安全 应对措施

2024

实验技术与管理
清华大学

实验技术与管理

CSTPCD北大核心
影响因子:1.651
ISSN:1002-4956
年,卷(期):2024.41(5)