Single TOC Analyzer Serves Dual Role: WFI and Cleaning Validation Sample Analysis


This white paper from Teledyne Tekmar demonstrates how a TOC analyzer that has very low limits of detection (LOD and LOQ), and is capable of recovering high levels of organic contamination without carryover between sample vials, was designed for implementation into a cGMP environment. Special emphasis was placed on the ability to accurately analyze WFI and cleaning validation samples using a single TOC instrument and SOP. The results are dramatic reductions in instrument performance qualification, training, and method development times, as well as an increase in sample throughput.