[Application Note] This document introduces appropriate procedures for recovering complex compounds such as alkaline cleaning agents using TOC.
Cleaning validation in the pharmaceutical industry is a crucial process to ensure the quality and safety of products. This importance increases significantly when dealing with complex compounds. We will introduce the evaluation of recovery rates of alkaline cleaning agents using Sievers' TOC measurement technology.
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- Advantages of TOC Measurement Technology TOC can be used to measure the amount of organic residues remaining on the surfaces of cleaned equipment. The TOC analytical technique completely oxidizes the organic matter in the sample to carbon dioxide and determines the TOC by measuring the concentration of the generated carbon dioxide. The Sievers gas-permeable membrane conductivity detection method prevents interference from acids, bases, and halogen compounds, enabling highly sensitive and accurate TOC measurements. This technology allows for precise evaluation of the cleaning process's performance. - TOC Recovery Rate Testing of Cleaning Agents Cleaning agents were prepared in the range of 0.3 ppm C to 5 ppm C, and linearity was evaluated using the Sievers TOC analyzer in accordance with ICH Q2(R1) recommendations, resulting in favorable outcomes. For more details, 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.