FEATURE u Medical Equipment & Devices
Kistler provides quality assurance for medical device manufacturers
T
he Kistler maXYmos TL ML is one of the first process monitoring systems to meet the strict FDA and MDR
regulatory requirements for quality assurance in the medtech sector. The new monitoring system can deliver 100 per cent testing; a critical requirement for manufacturers operating in environments where pharmaceutical goods and medtech equipment are produced. The new maXYmos TL ML, based on the tried-and-tested maXYmos system, can be easily qualified and validated for integration into existing quality management systems. Process monitoring systems play an
increasingly important part in quality assurance on automated production lines. Medical device manufacturers must demonstrate that their products meet the requirements for safety and quality and provide proof of the reliability and precision of quality assurance monitoring not only throughout their own manufacturing process but also that of their suppliers.
EXCLUDING LIABILITY In extreme cases, inadequate quality assurance, during the production of medical devices, can cause injury or even loss of life. Companies that place medical devices on the market are fully liable in the event that their products fail to function accurately and consistently. This is partly why the industry is subject to such strict regulation. Producers of medical devices,
as well as plant and machinery manufacturers, operating in the medtech and pharmaceutical sectors are confronted with huge challenges, especially when it comes to integrating process monitoring systems into automated production and packing processes.
FDA AND MDR-COMPLIANT Kistler has developed this new solution on the basis of its maXYmos TL (Top Level) well proven system. Like all the systems in the maXYmos family, TL visualises process profiles and offers an extensive range of interfaces for connecting sensors. The system is integrated directly into the production line to monitor and evaluate the quality of every step in the manufacturing process on the basis of a curve. With the help of evaluation objects (EOs), users can adapt the curve evaluation to the specific monitoring task. For instance, the tolerances defined in the process validation can be used for this purpose. Based on this specification, the system then decides whether each workpiece is good or bad. The functions integrated in maXYmos TL ML comply with the regulatory requirements for applications in the medtech industry. The system hardware also meets the specific requirements for measurement equipment in the medtech sector, including: - Exceptionally small measuring ranges (force-displacement monitoring, torque sensor technology);
- Integrated user management compliant with FDA regulatory requirements; - Audit trail of all changes to testing processes, with time and user indexing for end-to-end traceability of each individual product;
- Optional blocking of ports for secure integration into the customer’s data structure; - Direct printer connection so that test records can be documented as hard copies.
THE COMPETITIVE EDGE The new maXYmos TL ML gives producers of medical devices a much easier solution to the validation of their production processes. With 100 per cent inspection of each step in the manufacturing process, the need for mandatory process validation in production can be completely eliminated. Qualification of the production equipment is the first requirement for proof of the system’s safety. For this purpose, Kistler supplies ready- to-use checklists for Installation Qualification (IQ) and Operational Qualification (OQ). An in-plant calibration can then be performed to validate the measurement system at any time – a service that Kistler offers for its customers throughout the world. This also makes requalification of assembly plants much simpler, because the entire measuring chain is calibrated. The key benefit to manufacturers is that they can bring their product developments and innovations to market much more quickly giving them the competitive edge that is such a critical factor in this industry. The maXYmos TL ML system supports
OPC UA, so that it can be easily connected to machine controls and communicate with higher-level control and management systems.
Kistler Instruments Limited 30 October 2021 Irish Manufacturing
www.kistler.com
www.irish-manufacturing.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40
