TOC analytical method in cleaning validations: criteria, limits and robustness of the process

Total Organic Carbon (TOC) analysis is an essential tool for verifying the effectiveness of cleaning processes in pharmaceuticals and biotechnology, thanks to its high sensitivity and ability to detect any organic residue. This article reviews the critical factors of the method, the criteria for establishing acceptance limits—both toxicological and based on process capability—and the key considerations for validating the technique and recovery studies, highlighting the role of TOC as a robust and GMP-compliant method.

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