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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: To monitor the suspended particles and sedimentation bacteria in the pharmaceutical production environment and maintain the cleanliness level to meet the requirements of the pharmaceutical production quality management standard. Methods: To determine the number of suspended particles in the air of the clean room in the key process of preparation production; collect the sedimentation bacteria on the plate and count the number of colonies visible to the culture to determine the cleanliness level. Results: 300,000 workshops measured 100,000 and 10,000; 100,000 workshops measured 100,000 and 10,000, partially up to 100. Conclusion: The Company’s preparation of clean environment in line with national regulatory requirements.