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Don’t let difficult substances control your cleaning validation

may 17, 2019 By europeanpharmaceuticalreview

TOC analysis is a widely adopted method for detecting residual product or cleaning agents on manufacturing equipment. Compared to specific methods such as HPLC, TOC can provide better process understanding and efficiency for cleaning validation (CV), verification and continuous monitoring.

Some products have complicated organic structures and/or are difficult to oxidise, such as proteins and high molecular weight compounds. For these challenging applications, it may be necessary to consider different TOC vial types and perform recovery studies to determine suitability. While some substances are difficult, it doesn’t always mean they can’t be recovered.

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