2014年苏州94家医疗器械生产企业微生物实验室设计现状调查

Investigation of Microbial Lab Design in 94 Medical Device Manufactories in Suzhou in 2014

目的:了解医疗器械微生物实验室的设计现状和管理情况,并对存在问题进行分析,以期能设计出满足监管要求和实用的微生物实验室。方法:对2014年苏州地区94家医疗器械生产企业微生物实验室布局、生物安全设计、功能区设置及人均洁净室面积进行数据分析。结果:医疗器械企业微生物实验室存在洁净室设计布局落后,对生物安全关注度不够,功能区设置不合理、人均洁净室面积较小等问题。结论:对于新建微生物实验室,无菌室、微生物限度室和阳性对照室三室分开,各自采用专用的空气净化系统和独立的人流物流是监管的趋势。

Objective： To understand the current situation and management of microbial lab in medical device manufactories, and analyze the existing problems, so as to design qualified and functional microbial labs that can meet the supervisory requirements. Methods： Data about microbial lab layout, Bio safety control, functional room design and clean room area for each person from 94 medical device manufactories located in Suzhou in 2014 were analyzed. Results： Microbial lab layout fell behind the regulatory requirements. Attention paid to Bio safety control was not enough. The design of functional rooms were not reasonable. Clean room area for each person was too small. Conclusion： For the establishment of new microbial lab, sterile test room, microbial limit test room and positive control room should be separated with each having its own separate human flow and material flow.