优化臭氧对药品生产洁净区的灭菌条件

Optimizing the Sterilization Conditions of Ozone in the Clean Area of Pharmaceutical Production

目的运用CF-G-2-900g臭氧发生器进行制药企业洁净区的灭菌研究,优化臭氧对洁净区灭菌的条件,建立合适的洁净区灭菌方法。方法针对臭氧对洁净区灭菌率的影响因素:臭氧浓度、臭氧作用时间、环境相对湿度,采用正交试验寻找最佳臭氧消毒灭菌条件,从而得到臭氧对洁净区消毒灭菌的最佳效果。结果确认了CF-G-2-900g臭氧发生器对9000m^3洁净区的最佳消毒灭菌条件,即臭氧投加比80%,臭氧发生器运行时间90min,环境相对湿度为70%,臭氧对洁净区的灭菌率可达到90%。结论臭氧对药品生产洁净区有效灭菌条件为,臭氧浓度大于10ppm,有效作用时间大于30min。

OBJECTIVE Using CF-G-2-900g ozone generator to carry out sterilization research in the clean area of pharmaceutical companies,optimize the conditions of ozone sterilization in clean zone to establish a suitable clean area sterilization method.METHODS According to the influencing factors of ozone on the sterilization rate in the clean zone:the concentration of ozone,the time of ozone action,and the relative humidity of the environment,using Orthogonal experimental to find the best ozone disinfection and sterilization conditions.RESULTS The research confirmed the best disinfection and sterilization conditions of the CF-G-2-900 g ozone generator in the 9000m^3 clean area,that was,the ozone dosing ratio was 80%,the ozone generator running time was 90 minutes,and the environmental relative humidity was 70%.Under these conditions,the sterilization rate of ozone in the clean area reached more than 90%.CONCLUSION The effective sterilization conditions of ozone in the clean area of pharmaceutical production are:ozone concentration is more than 10ppm,and the effective action time is more than 30min.