Operational Qualification of Tumbling/Deburring Process for Medical Device Components
A cardiovascular medical device manufacturer required documented evidence that their tumbling/deburring process for machined CDI components would not produce unacceptable product when operated at process extremes. The challenge involved validating multiple equipment platforms (three tumblers and one centrifuge) across varying part geometries, materials (plastic and aluminum alloys), and process parameters including run time, media type, machine agitation, and batch quantities. Critical concerns included preventing under-processing (insufficient burr removal) and over-processing (part damage or dimensional changes).
Project Metrics
Tools & Standards
Problem Definition
A cardiovascular medical device manufacturer required documented evidence that their tumbling/deburring process for machined CDI components would not produce unacceptable product when operated at process extremes. The challenge involved validating multiple equipment platforms (three tumblers and one centrifuge) across varying part geometries, materials (plastic and aluminum alloys), and process parameters including run time, media type, machine agitation, and batch quantities. Critical concerns included preventing under-processing (insufficient burr removal) and over-processing (part damage or dimensional changes).
System Constraints
Engineering Decisions
Selected worst-case parts representing softest material, hardest material, and most complex geometry
Established process extremes: minimum/maximum run times (1-3 hours)
Tested minimum and maximum batch quantities
Validated with softest and standard media types
Tested lowest and highest machine agitation settings
Leveraged prior lab study (LS14412) demonstrating dimensional stability at 3-hour maximum
Implemented visual inspection test method previously validated per TMV 857089
Validation Strategy
- All 186 parts successfully passed visual inspection per manufacturing work instruction
- Under-processing worst case: Complex geometry and hardest material parts tumbled at minimum time (1 hour) with soft media passed inspection
- Over-processing worst case: Softest material parts tumbled at maximum time (3 hours) with standard media showed no deformation or damage
- All four equipment platforms (three tumblers, one centrifuge) qualified via Installation Qualification reports
- Zero deviations during protocol execution
- Visual inspection confirmed complete burr removal without dimensional impact
Risk & Mitigation
Final Outcome
Successfully qualified the tumbling/deburring process across all equipment platforms with zero deviations. Demonstrated that the process operates safely within established parameters, preventing both under-processing and over-processing. The validation established a robust process window suitable for production use across 11 CDI component part numbers, providing documented evidence of process capability for regulatory compliance.