Class II medical device assembly — ISO 8 cell, 100% UDI
Cleanroom assembly cell with Stäubli stericlean robot, UV laser marker, and per-unit UDI capture.
- Client
- Confidential — Class II Medical OEM
- Location
- Minnesota, USA
- Capabilities
- Turnkey Line Build · Robotics Integration
The challenge
OEM launched a Class II device with FDA UDI requirements. Their previous hand-assembly cell could not meet the 0.95 Cpk target on the press-fit and could not maintain ISO 8 cleanroom integrity over a shift.
What we built
Stäubli TX2-60 stericlean robot in an ISO 8 hood handles press-fit and component placement. A Promess servo press captures force-displacement curves per unit. Trumpf UV laser marker writes the UDI; vision verification reads it before discharge.
Key equipment
- Stäubli TX2-60 stericlean
- Promess EMAP press
- Trumpf UV laser marker
- ISO 8 hood with HEPA
From the floor
Illustrative image — representative of project scope; customer-identifying details have been removed.
Results
Validated at Cpk 1.12 on the press-fit, ISO 8 maintained over an 8-hour shift, and UDI capture is 100% with audit trail to the MES.
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