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