KWSP were approached by an ink manufacturer to design, build and develop a printing cell for a flexible robotic manufacturing line which produces medical devices.
The Challenge
- Design, build and develop an FDA / GAMP compliant manufacturing cell
- To run 360 days / year, 23 hours / day
- redundancy and automated cleaning and print head recovery
- Line running at 10,000 parts / hour
- ‘Blank sheet’ to integration in 10 months
The Requirements
- Seamless integration of the system into the host cell (mechanically, electrically and for automation)
- Demonstrate compliance with high regulatory standards
The Approach
- Collaborative engagement with manufacturing line owner
- Failure modes designed through use of review and control tools (DFMEA, PFMEA)
- Use of linear motors to improve cleanliness and reduce wear of parts
- Ongoing compliance verification through use of GAMP tools
The Results
- Delivered 7 axis cell according to original aggressive timeline
- Delivered to budget
- System integrated into host machine well
- System passed acceptance tests without remedial correction
- System is compliant with the all applicable regulatory frameworks