摘要
目的:对疫苗生产企业的目标清洁产物的检测方法进行验证,以找到适合于疫苗生产企业制药设备清洁样品的检测方法。方法:规定残留限度10-5作为清洁验证的标准,对目标清洁产物稀释至10-5进行鉴别试验、总蛋白检测和总有机碳(total organic carbon,TOC)检测,对比分析选择适宜的清洁验证分析方法。结果:TOC分析方法精密度可达到要求。建立的清洁验证规程可行,对实际的清洁淋洗水样品进行检测,TOC数据重现性良好,RSD小于10%,低于设立的允许残留限值。结论:TOC分析方法适用于含有混合有机物清洁样品的检测,该方法非常适用于疫苗生产企业制药设备的清洁验证。
Objective： To validate the detection method of target cleaning products in vaccine production enterprises, so as to find a method for cleaning the sample of the pharmaceutical equipment in the vaccine production enterprise. Methods：The residue limits of 10-Swas defined as cleaning. The target cleaning products were diluted to 10-5 for standard and experimental identification and validation, total protein and total organic carbon （ TOC ） detection. Finally, comparative analysis was performed to select suitable cleaning validation analysis method. Results： The TOC analysis method could meet the requirements of precision. The establishment of a clean verification procedure was feasible for the actual cleaning rinse water samples detection. The TOC data reproducibility was good with RSD less than 10%, which was lower than the set of allowable residue limits. Conclusion： The total organic carbon analysis method is suitable for the detection of clean samples containing mixed organic compounds. The TOC method is very suitable for the cleaning validation of pharmaceutical equipment in vaccine manufacturing enterprises.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2016年第8期1465-1469,共5页
Chinese Journal of Pharmaceutical Analysis
关键词
总有机碳
生物制品生产
清洁验证
残留物
鉴别试验
总蛋白测定方法
TOC检测
精密度
GMP验证
total organic carbon （ TOC ）
biological products production
cleaning validation
residue
identification test
total protein determination method
TOC test
precision
GMP verification
