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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.

In the pharmaceutical industry, cleaning validation and product changeover are essential processes to ensure product quality and safety. However, traditional laboratory sample analysis is time-consuming and costly, leading to delays in production schedules. Therefore, the introduction of at-line TOC measurement is gaining attention. - Benefits of Introducing Portable TOC Meters The Sievers M9 portable TOC meter provides measurement results that are equal to or better than those obtained in the lab. The manufacturing team can perform sampling and measurement on-site and quickly document the results, eliminating the need for the quality control team to report results and wait for equipment approval. By implementing at-line TOC methods, annual sampling costs can be significantly reduced.

Sievers brand TOC analyzers, standard solutions, and consumables have been used by users around the world for over 30 years. Recognized as a global leader in TOC measurement technology, Sievers provides the highest quality standard solutions and consumables through expertise and Six Sigma methods. The pre-prepared standard solutions are designed for applications such as calibration, verification, and system suitability, and can also be used with TOC analyzers from other manufacturers. Additionally, we offer TOC vials with a cleaning guarantee of less than 10 ppb and cleaning validation kits.

● No calibration required, reagent-free measurement ● Ultra-low maintenance design with air cleaning + ultrasonic cleaning method

●Measurement of organic substances that cannot be detected by UV ●Higher sensitivity than differential refractive index detector (RI) The Sievers TOC Analyzer M9 SEC is a detector for organic substances separated by molecular weight using a GPC/SEC system. It is capable of measuring organic substances that do not absorb UV light (such as alcohols and polysaccharides) with higher sensitivity than a differential refractive index detector (RI). Application examples: Measurement of refractory organic substances in environmental water, optimization of membrane treatment for wastewater, management of activated carbon injection amounts, measurement of precursor substances for disinfection by-products, quality control of pharmaceuticals, cosmetics, and plastics.

In the pharmaceutical industry, processes that are free of waste and continuous improvement are required. Efficient processes enable the provision of safe and high-quality pharmaceuticals when needed. By adopting real-time testing of pharmaceutical water, it is possible to streamline the manufacturing process while ensuring quality. At Central Science, real-time testing of TOC and conductivity using the Sievers TOC analyzer optimizes the monitoring of pharmaceutical water systems, achieving better process control, productivity improvement, and risk management for cGMP processes. **Features** - Reduces costs, resources, contamination, lab errors, and data delays associated with traditional lab analysis - Detects and addresses OOS and OOT in real-time - Continuous control and system validation - Setting of alert levels and action levels based on trend data In the PDF data, you can find technical materials related to TOC real-time testing and information on the "Online TOC Analyzer Sievers M500" and "Sievers M9 Lab Model for Pharmaceutical Water/Cleaning Validation." *For more details, please download the catalog or contact us directly.*