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| Study on Cleaning Sampling Methods for Equipments |
| JIN Xian-rui1,DONG Rong-mei2 |
| 1. Zhongrun site,CSPC Zhongruo Pharmaceutical(Shijiazhuang ) Corporation Ltd., Shijiazhuang 050041, China; 2.Hebei Huarong Pharmaceutical Corporation Ltd.,Shijiazhuang 050000, China |
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Abstract The choosing of sampling methods and sampling points were studied in equipment cleaning validation. The sampling points should stand for "the dirtiest point" of the equipment. The most difficult cleaning site should be firstly considered when looking for the representative sampling point. The two sampling methods were introduced that the surface swabbing method and elution method. According to the routine cleaning validation of company, different cleaning validation protocols were set up for one key equipment, based on the comparison and analysis of validation results, the reasonable application of surface swabbing method and elution method were elaborated.
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| [ 1 ] 刘华本. 制药设备清洁验证的关键步骤[ J ]. 医药导报,2009,(5).[ 2 ] 黎 阳. 浅谈药品生产设备清洁验证[ J ]. 中国药事,2008,(5).[ 3 ] 国家食品药品监督管理局药品安全监督司,药品认证管理中心组织. 药品生产验证指南[ M ]. 北京:化学工业出版社, 2003. |
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