Patrice Kelty MBA, Marketing Communications Director at MMT discusses the company's Glebar P5K gauging system and its use in medical device manufacturing.
In the intricate world of medical device manufacturing, precision and quality are paramount. Every step of the process, from initial design to final inspection, must adhere to strict standards to ensure the safety and effectiveness of medical devices. Central to this journey is the equipment that facilitates the manufacturing process, particularly in handling complex measurements and inspections.
At the heart of modern medical device manufacturing lies the intricate process of measurement and inspection. Components must be precisely measured to meet exact specifications, ensuring they function as intended within the human body. This metrology process involves scanning multiple parts or long components, detecting minute defects, and providing accurate feedback for adjustments. It is critical that the technology handle these tasks efficiently and accurately to maintain product quality and regulatory compliance.
The Glebar P5K Gauging System’s versatility shines through in its ability to inspect a wide range of components with exceptional ease. From delicate medical guidewires and arthroscopic shavers to robust titanium fasteners and medical bone drills, the system delivers accurate measurements at the push of a button. This capability streamlines the inspection process across diverse product lines, ensuring consistent quality standards.
The P5K system’s software prowess extends to profiling geometric shapes up to two (2) meters in length, accommodating varying product dimensions effortlessly. Moreover, its automatic communication of production results empowers even the most junior employee to
measure complex dimensions accurately. This democratisation of measurement capabilities enhances operational efficiency and quality control across all levels of workforce expertise.
Furthermore, the P5K system drastically reduces setup times by scanning all parts in a cycle at all stations, providing realtime feedback on diameter, length, and geometric position adjustments to the grinding system. This comprehensive approach not only accelerates the inspection process but also enables precise corrections. The system automatically corrects dress shape, ensuring precision and consistency in a matter of seconds. This seamless integration of data feedback and automated adjustments optimises production workflows, minimizing downtime and maximizing productivity.
UNMATCHED PERFORMANCE:
At its core, the Glebar P5K Gauging System offers unparalleled accuracy and speed. Capable of scanning multiple short parts or one long part in a single operation, this system expedites the inspection process without compromising precision. With a remarkable scanning rate of 16,000 diameter readings per second, operators gain realtime data, empowering them to make informed decisions swiftly.
SIMPLICITY MEETS POWER:
The brilliance of the P5K system lies in its simple yet powerful user interface. Operators can initiate scanning
with a single mouse click after clamping the part in the fixture. The system presents results clearly as a definitive “Go” or “No-Go,” enabling rapid assessment of product quality on the manufacturing floor. This intuitive interface minimises training time for new operators and enhances overall productivity.
ENHANCED TRACEABILITY AND ANALYSIS:
Beyond basic measurements, the P5K system excels in detecting even the minutest defects. Its automatic measurement capability ensures consistency and accuracy, free from any operator influence. Quality managers benefit from comprehensive analysis data and traceability, crucial for compliance with stringent quality standards. The system’s reporting, lot control, and data aggregation features facilitate Statistical Process Control (SPC) analysis, driving continuous improvement initiatives.
RELIABILITY AND INTEGRATION:
With stable calibration and no moving parts, the P5K system offers reliable performance over time. Mounted on precision-lapped granite, it provides a qualified and thermally stable surface for precise measurements. For companies with multiple facilities, the system’s SQL version seamlessly connects to the intranet, centralising data measurements and templates across plants. This integration enhances data management efficiency and consistency across the organisation.
EMPOWERING CONTROL AND FEEDBACK:
The P5K system empowers operators with advanced control capabilities. It supports point-to-point dimensioning through simple clicks on part features, with unlimited zooming for detailed analysis. Operators can set warning tolerances to preemptively address potential deviations, ensuring proactive quality control. The system also provides size compensation feedback to Glebar CAM.2, GT-9AC, and GT-610 CNC machines, facilitating seamless integration into the manufacturing process.
STREAMLINED TRACEABILITY AND REPORTING:
All data, templates, results, and raw scan information are stored within the metrology system, ensuring comprehensive product traceability. Result data can be easily imported into popular software tools for further analysis and reporting, enhancing transparency and accountability throughout the production cycle.
In conclusion, the Glebar P5K Gauging System represents a paradigm shift in medical device manufacturing quality control. Its combination of precision, speed, user-friendly interface, and advanced analysis capabilities positions it as a catalyst for excellence and innovation in the industry. With the P5K system, manufacturers can achieve unmatched levels of accuracy, efficiency, and compliance, ushering in a new era of precision-driven production methodologies. Incorporating case studies further illustrates the real-world applications and benefits of the Glebar P5K Gauging System, solidifying its position as a cornerstone of automation excellence in medical device manufacturing.
