Quality is an essential element of every process, program, product and solution at Avantor and is the foundation for the value we deliver every day.
Avantor’s Devens, MA single-use manufacturing and assembly facility is ISO 9001:2008 certified and FDA cGMP compliant. All single-use assemblies are fabricated in an ISO Class 7 (10,000) certified cleanroom with environmental controls in place and monitored daily.
Our single-use quality systems are precisely managed, with fully documented procedures and validated processes in place where applicable, to ensure our customers receive reliable products with full lot traceability. A certificate of compliance accompanies all of our single-use assemblies and backing certifications for assembly components are available upon request.