Integra has a fully documented quality system that is precisely managed. All of our procedures are fully documented with validated processes in place where applicable. Integra’s strong attention to detail ensures the end user is consistently receiving reliable product with full lot traceability. A certificate of compliance accompanies all single-use assemblies. Backing certifications for assembly components are retained at Integra and are readily available upon request.
All single-use assemblies are fabricated in an ISO 9001:2008 certified and FDA cGMP compliant facility. Integra’s Quality Management System undergoes frequent audits performed by large and mid-tier biopharmaceutical companies. All single-use assemblies are fabricated in an ISO Class 7 (10,000) certified cleanroom. Environmental controls are in place and monitored daily.