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Process monitoring solutions for medical device manufacturing

Process monitoring solutions for medical device manufacturing

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At the Medical Expo MD&M West 2022 (April 12 to 14, 2022, in Anaheim, CA, U.S.A.), Kistler will showcase its broad range of process monitoring and measurement solutions for medical device manufacturing. Visitors will be able to experience the wide-ranging possibilities for efficient and reliable monitoring along the entire value chain – from injection molding over vision inspection up to assembly and testing.

Process monitoring systems play an increasingly important role in the production and quality assurance of medtech devices. They allow manufacturers to respond to the high demands for validation, quality assurance and documentation while containing costs. At MD&M West, Kistler will demonstrate how its proven systems for injection molding, assembly and testing help medical device manufacturers meet the requirements of the medtech industry and at the same time making production more efficient.

ComoNeo: comprehensive support for injection molders
Medical device manufacturers have been able to rely on the process monitoring system ComoNeo from Kistler to turn injection molding into a transparent process from qualification over validation through serial production. With its newly added innovative features, the system is even more accurate and supports users during the entire validation process. That includes improved control assistance functions, and even model-based prediction of part quality for process transparency and traceability. The integrated user management and audit trail functionality guarantees a maximum of process safety and security. ComoNeo’s extended interface includes OPC UA, ensure secure, reliable transmission of data to the injection molding machine and other peripherals.

KVC 621: optical test system for continuous materials in punching processes

csm Optical test system for continuous material KVC 621 774x515 ff957429f2

The KVC 621 optical test system from Kistler operates with maximum precision, allowing for 100 percent inspection of continuous material in medical device manufacturing.

The portfolio of Kistler for medical device manufactures also includes solutions for test automation, such as the KVC series for visual inspection. The systems of the series ensure fast and precise control of series parts – especially when large production quantities are involved. The KVC 621 from Kistler is a universal, autonomous video measurement system for 100 percent inspection of continuously produced parts like stamped connectors. The integrated control and image processing components focus on high, individually adjustable processing speeds for complex assignments with transmitted and reflected light. It is available in various sizes, including an extra-compact version for confined spaces and a version with extended installation space, for example to accommodate additional cameras. The KVC 621 achieves outstanding performance and process reliability, operating with maximum precision in the µm range at high, individually adjustable processing speeds of up to 6.000 measurements per minute.

csm Medical device assembly and testing with maXYmos TL ML 774x515 3a2fc76da2

maXYmos TL ML, the process monitoring system for medical device assembly and testing from Kistler offers FDA- and MDR-compliant functionalities making it easier for medical device manufacturers to meet demanding quality assurance requirements.

maXYmos TL ML: FDA- and MDR-compliant process monitoring system
When it comes to joining and assembly, the maXYmos TL ML from Kistler has proven its worth: the process monitoring system was designed specifically for the medical industry and is the first worldwide to comply with FDA guidelines and MDR regulatory requirements for applications in the medtech industry. Thanks to the maXYmos TL ML, validating production processes has become much easier: the system visualizes and analyzes process profiles and offers an extensive range of interfaces for connecting sensors. It can be integrated directly into the production line to monitor and evaluate the quality of the given manufacturing step on the basis of process tolerances.

Electromechanical joining systems for a more efficient production
In addition, Kistler will also be presenting its electromechanical joining systems including force and displacement measurement, rounding off its portfolio of solutions along the entire value chain. Electromechanical solutions in particular offer various advantages for medical device manufacturers. Compared to conventional solutions such as pneumatic and hydraulic joining systems, the electromechanical variants operate more efficiently and improve the production’s flexibility with respect to joining and press-fitting processes. In addition, they consume less energy, helping manufacturers reduce their CO2 emissions.

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