This comprehensive case study explores Kymanox’s approach to automated test fixture development through integrated mechanical, electrical, and pneumatic system design. Our team of Subject Matter Experts (SMEs) collaborated closely with medical device manufacturing stakeholders to implement measurable improvements across vacuum decay testing. This included GMP compliance, test method validation, and production line integration for high-volume blood collection device quality control operations.
CHALLENGE
SOLUTION
RESULTS
- Medical device manufacturer required custom test fixture performing four simultaneous vacuum decay tests for blood collection devices on production manufacturing line.
- Fixture design needed to meet stringent GMP standards with efficient operation, intuitive User Interface (UI), and automated pass/fail alert functionality.
- Comprehensive test method validation essential ensuring reliable, reproducible results supporting quality control decisions and regulatory compliance requirements.
- High-throughput testing capability required supporting approximately 900,000 devices annually in 8-hour daily operations meeting demanding manufacturing production schedules.
- Designed comprehensive mechanical and electrical layouts including precision device nests, integrated system pneumatics, electronics enclosure, and operator safety touchpoints meeting GMP standards.
- Procured and integrated combination of off-the-shelf components and custom machined mechanical, electrical, and pneumatic parts optimizing performance and cost-effectiveness.
- Programmed four Zaxis vacuum decay units with custom testing recipe detecting specific leak thresholds and configured Programmable Logic Controller (PLC) controlling all units simultaneously.
- Performed rigorous cross-gauge Repeatability and Reproducibility (R&R) analysis using Minitab® statistical software for comprehensive test method validation.
- Validated measurement system capability ensuring consistent, accurate results across operators, time periods, and environmental conditions.
- Successfully delivered validated 4-up test fixture accurately measuring vacuum decay rates and integrating seamlessly into existing production line workflow.
- Enabled reliable automated pass/fail alerting with single operator oversight testing approximately 900,000 devices annually in efficient 8-hour daily operations.
- Achieved full GMP compliance and successful fixture validation with gauge R&R analysis confirming robust, accurate quality control for blood collection devices.
- Established scalable testing platform supporting high manufacturing throughput standards while maintaining stringent quality control and regulatory compliance requirements.