Real-time low-flow cleaning efficacy evaluation of pharmaceuticals using TOC and conductivity.
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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.
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For specific evaluation methods of the cleaning efficacy of pharmaceuticals, please refer to the application note.
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Cleaning validation
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Since our establishment in 1967, we have been dedicated to the development and dissemination of water quality measurement devices that anyone can use quickly, easily, and with high precision. In today's world, where the effective use of water, a limited resource, is required alongside environmental conservation, we aim to be a total solution provider that responds to all water environments by utilizing our water quality measurement devices, technology, and services. Furthermore, leveraging the latest technology and years of know-how, we are committed to delivering user-friendly and reliable water quality measurement devices more affordably, quickly, and widely.