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Dual Purpose Total Organic Carbon (TOC) Analysis: Utilization of a single TOC Analyzer for Pharmaceutical Water for Injection and Cleaning Validation Sample Analysis
Industry: Pharmaceutical
Instrument: Phoenix 8000 Total Organic Carbon (TOC) Analyzer
Total Organic Carbon (TOC) analysis in the pharmaceutical, biotech and nutraceutical industries is standard practice in accordance with USP 643 for monitoring pure water (PW) and water for injection (WFI) quality. Because of its nonspecific “whole product” nature, however, Total Organic Carbon (TOC) use outside this application was initially slow to occur. As Total Organic Carbon (TOC) has grown in acceptance in recent years though, its versatility has evolved to include cleaning validation applications typically reserved for single product assays such as ELISA, Lowry and HPLC. In order for Total Organic Carbon (TOC) to develop as an analytical tool in quality control labs, it was necessary to have available, a dualfunction instrument that can analyze both WFI/PW and cleaning validation samples without modification or sample carryover concerns.
A Total Organic Carbon (TOC) analyzer exists, that has very low limits of detection (LOD and LOQ) while at the same time is capable of recovering high levels of organic contamination without carryover between sample vials. This work demonstrates how such a dualfunction Total Organic Carbon (TOC) analyzer 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 Total Organic Carbon (TOC) instrument and SOP. The results are a drastic reduction in instrument performance qualification, training, and method development times, and an increase in sample throughput.
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