总有机碳TOC分析在制药设备清洁验证中的应用

目的:中国2010年版GMP要求制药企业对生产设备进行清洁验证,总有机碳TOC (Total Organic Carbon)分析是适用于清洁验证的分析方法。 方法:对妥布霉素的生产设备,建立了淋洗法与擦拭法结合的清洁规程,用TOC分析仪检测清洁验证的样品。 结果:TOC分析妥布霉素,得到良好的线性、回收率及精确度。建立的清洁验证规程可行,对实际的清洁验证样品检测,TOC数据重现性良好,低于设立的允许残留限值。 结论:TOC方法适用于制药设备的清洁验证。TOC表征所有的有机物污染程度,为设备清洁验证提供了有力的安全性和可靠性。

Objective: To do cleaning validation (CV) for production equipment according to China new GMP 2010 requirement for pharmaceutical manufacturers, by total organic carbon (TOC) analysis which is suitable for CV. Methods: For the production equipment of tobramycin,the CV SOP was established with combination of rinse and swab sampling methods,and the CV samples were analyzed with TOC analyzer. Results: A satisfactory linearity was obtained,so were recovery and precision when measuring tobramycin with TOC analyzer,which revealed that the established CV SOP was feasible.CV samples were measured through this SOP and the TOC result represented a good reproducibility which was lower than allowable residue levels. Conclusion: TOC is a good analysis method for CV of pharmaceutical equipment.TOC indicates contamination of all kinds of organics.It guarantees safety and reliability of CV procedure.

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