[Application Note] Applying PAT to At-Line Cleaning Validation Using TOC
In the pharmaceutical industry, cleaning validation and product changeover are essential processes to ensure product quality and safety. In particular, the use of at-line TOC measurement based on PAT is very useful. - PAT Guidance Introduced in 2004, PAT guidance is an innovative framework for drug development, manufacturing, and quality assurance. This guidance provides a scientific, risk-based approach and promotes innovation and efficiency improvements by the industry and regulatory agencies. The PAT guidance introduces the "at-line" method, which involves sampling and measurement close to the process. By using the Sievers M9 portable TOC meter, it becomes possible to test rinse samples and swab samples for cleaning validation and product changeover at-line.
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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.