GE Analytical Instruments

The use of total organic carbon (TOC) in cleaning validation has become a widespread best practice throughout the pharmaceutical industry as an analytical method designed to verify the performance of a validated cleaning process and associated critical cleaning parameters.1 Instead of focusing on product-specific analytical methods, many industry-leading companies have changed to TOC for this application because it provides a simple way to ensure that a validated cleaning process is still in control. While product-specific methods like High Performance Liquid Chromatography (HPLC) and Enzyme Linked Immunosorbent Assay (ELISA) are sometimes useful supporting the design or development of a cleaning process, TOC has a significant advantage over these methods throughout the design, validation, and continuous verification phases of a cleaning validation (CV) program.