无菌医疗器械生产洁净室监测问题的探讨

Study on Monitorning the Sterile Medical Devices Cleanrooms' Cleanliness

目的:如何有效地对无菌医疗器械生产洁净室进行监测,使洁净室的洁净度达到规定的要求。方法及结果:借鉴药品生产洁净室的设计和监测,从药品及无菌医疗器械生产洁净室两方面考虑,找出共同因素对无菌医疗器械生产洁净室监测的影响。结论:洁净室的设计、建设、监测与管理,是无菌医疗器械洁净室监测符合要求的重要保证。

Objective：To making the cleanrooms＇ cleanliness comply to requments,it＇s essential to monitor the sterile medical devices cleanrooms,Methods and Results：From two aspects,drugs and sterile medical devices,to find out the same influence to monitoring the sterile medical devices cleanrooms.Conclusion：Cleanrooms＇ design,contrustion,monitoring and management is important,to quarantee the sterile medical devices cleanrooms＇ cleanliness comply to requments.