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关于制药设备清洁验证中表面微生物擦拭取样方法和检验方法的验证实验 被引量:10

Validation Experiments on Wipe Sampling Methods and Test Methods of the Microorganism on the Surface of Equipments in Cleaning Validation of Pharmaceutical Equipments
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摘要 《药品生产质量管理规范》(2010年版)实施前,在制药设备的清洁验证中仅仅要求对化学残留的取样方法进行验证。而实施后新增了对表面微生物取样和检验方法验证的要求。建立了制药设备表面微生物擦拭取样回收率的验证方法,采用316 L不锈钢板作载体,以金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌作为细菌的代表,白色念珠菌、黑曲霉作为真菌的代表,采取擦拭取样法,通过薄膜过滤法回收微生物,计算回收率。同时建立检测制药设备表面微生物限度的检验方法。 Before the implementation of Good Manufacturing Practice (2010 Edition), the cleaning validation of pharmaceutical equipments required only the authentication of chemical residue sampling methods. After the implementation of Good Manufacturing Practice (2010 Edition), new requirement for the validation of surface microorganism sampling and testing method was added. In this paper, the authentication method for surface microorganism wipe sampling recovery rate of pharmaceutical equipments was established; Using 316L stainless steel plate as the carrier, using staphylococcus aureus, escherichia coli and bacillus subtilis as representative of bacteria, using candida albicans and aspergillus fungi as representative of funguses, the wipe sampling method was adopted, microorganisms were recovered by membrane filtration method ,and the recovery rate was calculated. At last, the test method of surface microbial limit for pharmaceutical equipments was established.
作者 刘杰
出处 《当代化工》 CAS 2012年第10期1009-1011,1013,共4页 Contemporary Chemical Industry
关键词 表面微生物 回收率 清洁验证 Surface microorganisms Recovery rate Cleaning validation
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参考文献3

  • 1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.药品生产验证指南(2003)[M].北京:化学工业出版社,2003-07.
  • 2国家食品药品监督管理局药品认证管理中心.药品生产质量管理规范实施指南(2001)[M].北京:中国医药科技出版社,2011-07.
  • 3中国药品生物制品检定所,中国药品检验总所.中国药品检验标准操作规范(2010)[M].北京:中国医药科技出版社,2010-09.

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