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

《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316L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。

Validation Experiments on Wipe Sampling Methods and Test Methods of the Microorganism on the Surface of Equipments in Cleaning Validation of Pharmaceutical Equipments

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.