摘要
药品微生物实验室系统是支撑完成药品微生物检验工作的技术平台,它的良好设计、管理与运转是药品微生物实验室质量管理体系的基础。在实验室系统的设计和建设中,实验室使用者应从初期就深入参与其中,根据试验任务决定系统设计,避免过高或过低的不合理要求;根据工作任务、工作流程确定实验室布局;实验室通入足够的新风,既能有效防止交叉污染又能够最大限度满足人员的舒适性和安全要求。微生物实验室日常运行时,应由专人与运维团队对接,共同合作完成实验室的运维管理。随着我国药品微生物标准体系和实验室建设标准体系的稳定和完善,通过良好的设计、建设和管理,一定能够建设出结构简单、运行稳定、经济高效、安全舒适的良好微生物实验室系统。
The pharmaceutical microbiology laboratory system is a technical platform that supports the completion of drug microbiology testing work.Its good design,management and operation are the foundation of the quality management system of the pharmaceutical microbiology laboratory.In the design and construction of laboratory systems,laboratory users should be deeply involved from the early stage,make decision on system design based on experimental tasks,and avoid unreasonable requirements that are too high or too low.They determine the laboratory layout based on work tasks and process flow.Adequate fresh air supply to the laboratory can prevent cross contamination while maximizing personnel comfort and monitoring.During the daily operation of the microbiology laboratory,a dedicated person should coordinate with the operation and maintenance team to jointly complete the operation and maintenance management of the laboratory.With the stability and improvement of China′s pharmaceutical microbiology standard system and laboratory construction standard system,through good design,construction and management,it is certain that a good microbiology laboratory system with simple structure,stable operation,economic efficiency,safety and comfort can be built.
作者
王似锦
马仕洪
WANG Sijin;MA Shihong(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国药品标准》
2023年第6期591-595,共5页
Drug Standards of China
关键词
药品微生物实验室
设计
建设
质量管理
pharmaceutical microbiology laboratory
design
construction
quality management
作者简介
第一作者:王似锦,副主任药师,研究方向:药品微生物控制。Tel:010-67095695,E-mail:wsj@nifdc.org.cn;通讯作者:马仕洪,主任药师,研究方向:药物分析和药品微生物控制。Tel:010-67095990,E-mail:mash@nifdc.org.cn。
