Application Note: Laboratory Evaluation Of Pharmaceutical Cleaning Validation Swab Sampling Using TOC Analysis

This application note presents results of a two-part laboratory recovery study. In the first part of the study, TOC recovery levels were determined for multiple test compounds to confirm suitability of TOC analysis for such samples. Second, TOC recoveries from swab samples of fortified test coupons are reported. Reproducibility, robustness, and limit of detection (LOD) of the swab sample TOC analysis method was assessed.