Paul Roberts, sales manager, advanced manufacturing for Kistler Instruments, outlines the critical nature of quality assurance for medical device manufacturers.
Although quality assurance (QA) has progressed from “end of line” manual inspection, often on a random sample basis, to automatic in-process monitoring of critical stages in the manufacturing operation using custom designed computer systems. Where critical components are being produced in quantity, typically for aerospace, defence and vehicle manufacturing applications, QA procedures are precisely defined and legally binding resulting in the availability of commercial, cost effective monitoring systems from several specialist producers. Medical device manufacturers must demonstrate that their products meet the highest safety and quality standards 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.
The medtech sector, where in-process monitoring is critical, manufacturers have had to adapt and use systems from other sectors which may or may not meet the strict FDA and MDR regulatory requirements. Companies that manufacture and market medical devices are fully liable in the event that their products fail to function accurately and consistently. 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.
In response to the need for a process monitoring system for the medtech sector, Kistler Group has developed the new maXYmos TL ML in-process monitoring solution specifically for the medtech manufacturing sector with FDA and MDR-compliant functionalities. A development of the well proven maXYmos TL system widely used in many manufacturing sectors, the new system 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 an X-Y 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 automatically identifies each product as good or bad at each stage in the process which not only ensures that every product is 100% in specification but also increases productivity and reduces costs by rejecting any that fail before any further, wasted stages in the process.
The functions integrated in maXYmos TL ML conform to the regulatory requirements and the system hardware also meets the specific requirements for measurement equipment that apply in medtech, including:
- Designed to accommodate 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.
Optimised production processes give manufacturers a competitive edge
The new maXYmos TL ML process monitoring system aims to give producers of medical devices, as well as machinery and plant manufacturers operating in the medtech and pharmaceutical sectors, an easier solution to the validation of their production processes. With 100% 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 in-house or by the Kistler calibration service available 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.
