Cleaning Validation Productivity: New Approaches for Recovery of Complex Compounds

The goal of any cleaning validation program is to reduce the risk of product contamination by minimizing carryover on manufacturing equipment while managing budgets.   Validation must prove that the cleaning process consistently removes product residue, process soils, potential contaminants, excipients, any degredants, as well as cleaning agents. This paper explores the capability and performance of the Sievers M9 Total Organic Carbon (TOC) Analyzer with four classes of compounds: Cleaning Agents, Excipients, Active Pharmaceutical Ingredients (APIs), and Biologics (proteins). 

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