生物制品的清洁验证,具体可参考:Technical Report No. 49Points to Consider for Biotechnology Cleaning Validation,如果是擦拭取样的TOC检测,需要做擦拭回收率的测试。
The TOC method can be used for rinse and swab measurements. If used for final rinse water testing, samples can be analyzed directly. If used for swab testing, the organic carbon has to be extracted from the swab after sampling. It is important to consider some additional topics during TOC swab method development, such as swab material and technique. Swabs should not significantly contribute carbon to the sample and should not adsorb significant amounts of the residue such that it is not released for analysis. The sampling technique (e.g., swab size and shape, swabbing pattern, swab container and extraction method) is much more complex in comparison to rinse water testing. The swabbing technique can have a high influence on residue recovery.
TOC方法可用于冲洗和擦拭子测量。如果用于最后的冲洗水测试,样品可以直接分析。如果用于擦拭子测试,采样后必须从擦拭子中提取有机碳。在TOC擦拭子方法开发过程中,考虑一些额外的因素是很重要的,例如擦拭子材料和技术。擦拭子不应向样品中添加大量的碳,也不应吸附大量的残留物,使其无法释放用于分析。取样技术(例如,棉签大小和形状、棉签模式、棉签容器和提取方法)比冲洗水测试要复杂得多。提取技术对残留物的回收影响很大。
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