照相系统检测无菌冻干产品扎盖前容器密封性的研究_new精要.doc

摘 要 关键词：风险 The study of camera system to monitor the container closure system Background: China GMP (2010 edition) has been published on Jan. 17th 2011. According to the GMP requirement on Annex 1, Chapter3, the clean environment and monitoring, the 13th item, the capping of aseptic products need to be settled on Class A area with Class B background. But according to the integrity of fully stoppered products, the design of the capping machine or characterize of the flip-off cap etc, the capping could be settled under Class A air supply with Class C or Class D background. According to this