摘要
目的:对药品生产环境的悬浮粒子及沉降菌进行监测,保持洁净度级别,以适应药品生产质量管理规范的要求。方法:测定制剂生产关键工序洁净室空气中悬浮粒子数;收集沉降菌于平板上,经过培养繁殖到可见的菌落计数,判定洁净度等级。结果:30万级车间实测达10万级和1万级;10万级车间实测达10万级和1万级,局部达100级。结论:本公司制剂生产洁净环境符合国家规范的要求。
Objective： monitor the suspended particulates and settlement bacteria in the pharmaceutical manufacturing environment, maintain the levels of the cleanliness,to meet the good manufacturing practice requirements. Methods：To determine the number of the suspended particulates of preparation and key processes in the clean room air; collecting settlement bacteria on the plate, breed and development, then count the numbers and judge cleanness grade. Results： 300,000 stage actually measure up to 100,000 stages and 10,000 stages; 100,000 stage actually measure up to 100,000 stages and 10,000 stages, local reaches to 100 stages. Conclusion：The company＇s production of clean and environmentally friendly preparation requirements in line with national norms.
出处
《亚太传统医药》
2011年第1期29-31,共3页
Asia-Pacific Traditional Medicine
关键词
洁净环境
悬浮粒子
沉降菌
置信度
Clean Environment
Suspended
Settlement Bacteria
Confidence
