《照相系统检测无菌冻干产品扎盖前容器密封性的研究》.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 requirement, if the capping is not settled on Class A area with Class B background, the integrity of the container must be validated and monitored.Purpose: The article will analysis and study the container closure system to prove that with the monitoring with camera system, the integrity of the container closure system could be maintained for fully stopped products and could prevent the potential microbiological contamination during the holding time before capping. Method: The article will analysis the key factors that related with the integrity of container closure system. It will first analysis the design of the container closure system and then analysis the control and monitoring methods. The results will be proved by validation. Results: According to the design study of container closure system, it is confirmed that the height between stopper and vial neck should be controlled less than 2.0mm with camera system monitoring; According to the study of camera system and capping process, the parameters of contrast and pixel are determined. The acceptance criteria is 5.2mm-7.2mm but when running at the highest speed, there’s a 0.2mm systematic error which need to be calculated in the acceptance criteria so that the range 5.2mm-7.2mm should be modified to 5.2mm-7.0mm. Then, the acceptance criteria optimizing study determines that the acceptance criteria for commercial p