Our objective is to demonstrate how Total Organic Carbon (TOC) analysis is a quick, accurate screening alternative for critiquing cleaning validation samples. Typical laboratory testing includes the development and implementation of analytical methods that test for residues of previously manufactured products, cleaning detergents, chemicals, solvents, byproducts, degradants, and microbial contaminates (from wet environments after the cleaning validation). TOC analysis has become one of a series of analytical methods used to assess the effectiveness of a cleaning validation. Almost any residual compound can be detected if three non-specific analytical (screening) tests are applied to a cleaning validation: TOC (for organics characteristics– carbon), pH (for acid/base characteristics) and conductivity (for ionic characteristics). Analytical precision and analyte recovery for cleaning agents (detergents) and other possible contaminates that may be found in clean in place (CIP) solutions will be investigated for TOC. TOC analysis demonstrated equivalent or better correlation to cleaning validation compounds in comparison to traditional analytical methods. Some qualities that make TOC a viable part of a cleaning validation includes: high sensitivity, high recovery of samples, non-specific measurement, ease of use (little method development), minimal interferences and cost effectiveness. This presentation will focus on the characteristics and benefits of TOC with general implementation guidelines for performing cleaning validation. By taking a proactive approach to one’s cleaning validation program, one can guarantee effective performance while minimizing downtime.

1. Total Organic Carbon & Swab Sampling Workshop Prepared By: Nikunj Vasoya (Research Assistant)