Validation Support System "maXYmos TL ML"
Automatically generate audit trails and IQ/OQ documents. Significantly improve the validation efficiency of medical device manufacturing!
The "maXYmos TL ML" is a manufacturing monitoring system that evaluates process quality using sensor signals and is compliant with validation requirements. It automatically generates the documents necessary for IQ/OQ and facilitates easy management of audit trails. It is compliant with FDA 21 CFR Part 11, making it ideal for overseas manufacturing as well. Settings and analyses are easily performed via a touch panel. It offers higher reproducibility compared to traditional visual inspections and contributes to the efficiency of approval processes. 【Features】 ■ Certified equipment under 21 CFR Part 11, widely adopted by overseas medical device manufacturers. ■ Switches from visual inspection to detect defects with higher precision and efficiency. ■ Judgment criteria can be set easily through touch panel operation. ■ Real-time analysis is possible without the need for data organization or processing. *In addition to the product catalog, we are currently providing materials that include case studies of overseas implementations. You can view them via "PDF Download." Please feel free to contact us for inquiries.
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【Application Examples】 ◎ Monitoring the assembly (press-fitting) process of insulin pens ◎ Monitoring the assembly process of the cover for disk-type inhalers ◎ Monitoring the assembly process of syringes with luer and covers, etc. 【Implementation Results *Partial】 Ypsomed Group, Ivers-Lee, and others *For details, please refer to the PDF materials. 【Unit Configuration】 ◎ Measurement and Evaluation Module (MEM) ◎ Display Module (DIM) *For more information, please refer to the materials. Feel free to contact us as well.
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For more details, please refer to the materials. Feel free to contact us as well.
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Kistler Japan is the Japanese subsidiary of Kistler Instrumente AG (Switzerland), which leads the world in piezoelectric crystal technology. For many years, Kistler has made significant investments in product research and development, achieving numerous revolutionary technological advancements and solving various measurement problems ahead of the world. Since its establishment in 1985, Kistler Japan has continued to provide a wide range of products, including piezoelectric sensors, strain sensors, charge amplifiers, and data processing/analysis software, as well as related equipment, technical support, and quality management services to customers in Japan and the Asia-Pacific region, based on its high technical capabilities backed by experience. *For a list of our products and the latest news, please visit our "Special Site." https://premium.ipros.jp/kistler/ *If you have any questions, please feel free to contact us through the "Contact Us" form below.