Quality Tools & Resources
- "Quality by design" approach to manufacturing
- Full-time quality manager
- Comprehensive inspection systems, including machine vision system and coordinate measuring machine (CMM)
- Certified auditors on staff
- Internal and external regulatory affairs expertise available to assist with filings, protocol development and other regulatory issues
- Validated and certified ISO 14644 Class 7 clean room with an environmental viable bioburden monitoring system and full IQ/OQ/PQ documentation
- Bag burster and Instron tester for testing and validation of peel force, pouch sealing, and eject force
- Incoming raw material inspection
- Ultrasonic cleaning baths
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