Real-time low-flow cleaning efficacy evaluation of pharmaceuticals using TOC and conductivity.

Application Note: Evaluation of Cleanability of Substances in Cleaning Processes Using TOC Analyzer

The design of a robust cleaning process for pharmaceutical manufacturing is crucial for cleaning validation. Traditionally, the design of cleaning processes in pharmaceutical manufacturing has focused on reducing the most potent and toxic active pharmaceutical ingredients (APIs). For validated cleaning processes, the emphasis is on reducing risks and demonstrating process control and understanding. A newly highlighted concept for risk reduction is the identification of comprehensive cleanability and master soil. In the past, potential substances were considered individually, and all substances were ranked based on the time required for cleaning completion under worst-case cleaning conditions. The master soil was established based on the time to cleaning completion, and the cleaning process was optimized around the reduction of the master soil. Often, this relied on subjective ranking through visual confirmation as a qualitative indicator. To optimize the cleaning process of pharmaceutical manufacturing facilities, we propose a method to measure total organic carbon (TOC) and conductivity in real-time to evaluate cleanability.

Analytical Equipment and Devices