PAT application: At-line TOC for Cleaning Validation and Product Changeover


The Food and Drug Administration's 2004 PAT guidance document for improving pharmaceutical manufacturing efficiency and quality discusses using at-line methods for data collection. This application note from GE Analytical Instruments demonstrates the applicability and capability of at-line total organic carbon (TOC) analysis for periodic swab sampling for cleaning validation and applying the same practices for product changeover using the Sievers 900 Portable TOC Analyzer.