总有机碳分析在制药设备清洁验证中的应用  

Application of total organic carbon analysis in validation of cleaning production equipment for pharmacy

作　　者：冯潇[1] 戈玲[1] 刘晨鸣[1] 徐永浩[1] 张玲玲[1] 魏然[1] 刘晓凡[1] 

机构地区：[1]兰州生物制品研究所有限责任公司质量检定室甘肃省疫苗工程技术研究中心,甘肃兰州730046

出　　处：《微生物学免疫学进展》2016年第3期43-48,共6页Progress In Microbiology and Immunology

摘　　要：目的证明总有机碳（Total organic carbon,TOC）分析是适用于清洁验证的分析方法之一。方法以生产中最常用的DMEM干粉培养基代替生产过程的残留物,采用了擦拭法,并用TOC分析仪检测该法清洁验证的样品的结果。结果采用TOC法分析检测DMEM培养基溶液,得到良好的线性,r〉0.99,回收率为98%~106%,RSD为2.07%~3.88%。检测限和定量限的TOC响应值分别为56和168μg/L。擦拭样品回收率为86.40%,样品放置1、4、8、24、30、48 h测出的TOC响应值之间的RSD为2.49%。结论该方法的线性、精密度、准确度、材料稳定性等均符合规定,方法简便、快捷,适用于制药设备的清洁验证。Objective To demonstrate one of methods, total organic carbon（TOC）analysis, in validation of cleaning production equipment. Methods Based on the most commonly used DMEM （powder） in production, so use it as replaced residues in production process. To take a swab sampling method, and the results for cleaning validation samples by this method were analyzed with TOC analyzer. Results The determined concentration in DMEM solution showed a good liner relationship to results obtained from TOC , with a r value more than 0.99. The recovery rate, RSD, MDL, MQL of the method were 98% -106% , 2.07% -3.88% , 56 tzg/L and 168 txg/L, respectivelly. The recovery rate of swab sample was 86.40%. The samples were stored at 1, 4, 8, 24, 30, 48 h and TOC of samples had a RSD value 2.49%. Conclu- sion The linearity, accuracy, precision and tested material stability in TOC analysis met related regulation, which was suitable in validation of cleaning production equipment for pharmacy, with a simple and fast in performance.

关 键 词：总有机碳 验证 清洁 棉签擦拭法 药品生产质量管理规范 

分 类 号：TQ460.5[化学工程—制药化工]