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Medical device manufacturing process monitoring system 'maXYmos TL ML'

Switching from visual inspection to reduce recall risk. Equipped with features that assist in validation. *A document featuring overseas implementation examples will be provided!

The "maXYmos TL ML" is a monitoring system designed for medical device manufacturing processes that collects signals from sensors installed in manufacturing equipment to detect manufacturing defects and foreign matter contamination. Based on clear judgment criteria, management and evaluation for each manufacturing process can be conducted inline, contributing to the prevention of defective products from being released and reducing recall risks. It also includes features that assist with validation, such as the output of documents and audit trails necessary for IQ and OQ, achieving a reduction in project duration. 【Features】 ■ 21 CFR Part 11 certified equipment, widely adopted by overseas medical device manufacturers ■ Switch from visual inspection to detect defective products with higher precision and efficiency ■ Easy operation via a touch panel to set judgment conditions ■ Real-time analysis possible without the need for data organization or processing *In addition to the product catalog, we are currently offering materials that include case studies of overseas implementations. You can view them through "PDF Download." Please feel free to contact us for inquiries.

Related Link - https://info.kistler.com/medical-ja

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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 document. 【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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Explanation document "Process Monitoring System to Accelerate Validation of Medical Device Manufacturing"

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