Managing the quality & risk of your single-use systems
Single-use systems must meet rigorous quality standards related to component qualification, manufacturing operations, in-process testing and final product release. Avantor can help companies implement single-use technologies that reduce contamination risk, improve resource efficiency and lower labour and energy costs. Our quality systems help ensure that you consistently receive products that you can trust, and our global single-use manufacturing locations are certified and adhere to ISO standards.
Key aspects of our quality and regulatory compliance systems:
Redundant cleanroom manufacturing facilities
- Certified ISO Class 7 assembly rooms
- Validated equipment and processes
Certified ISO 9001 quality system
- Compliant with FDA and EU cGMP requirements
- Robust and timely Complaint Handling and CAPA programs
- Risk-based quality management approach
Complete regulatory compliance program
- Detailed Certificate of Compliance accompanies all single-use assemblies
- Backing certifications for assembly components are retained and readily available upon request
- Animal origin-free or EMA/410/01 compliant materials
- Sterility validation per ANSI/AAMI/ISO 11137 (VDmax25)