There are two primary considerations for biopharma manufacturers to keep in mind when choosing a supplier of single-use products and assemblies: quality assurance and risk management through regulatory compliance as well as supply chain excellence and reliability.
Avantor® offers reliable single-use products, systems and assemblies for multiple biopharmaceutical processes including mixing, storage, sampling and fluid transfer. Our decades of experience with sourcing and designing single-use systems for biopharma manufacturing help ensure that you consistently receive solutions that you can trust.
With Avantor as your single-use manufacturing partner, you can be sure that the rigorous quality standards related to component qualification, manufacturing operations, in-process testing and final product release have been met.
Our holistic approach to sourcing and delivering high quality single-use assemblies helps companies implement single-use technologies that reduce contamination risk, improve process efficiency and reduce costs.
REDUCE YOUR RISK AND MOVE RESEARCH FORWARD
Key aspects of Avantor’s quality and regulatory compliance systems help you, and your team, make sure the single-use assemblies and products you rely on to move your research, scale-up and production forward, safely and efficiently.
Our risk reduction resources include:
- Certified ISO Class 7 assembly rooms
- Validated equipment and processes
- Compliant with FDA and EU cGMP requirements
- Robust and timely complaint handling and CAPA programs
- Risk-based quality management approach
- 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)
- Sterile barrier shelf life validation per ISO 11607
- Supply chain statements
- BPOG standardized extractables testing protocols and results
- Endotoxin (USP85) and particulate (USP788) lot release testing available
Managing risk in your global single-use supply chain
With the rapid growth of single-use systems for drug production, choosing the right single-use manufacturer can help mitigate risks associated with ensuring regulatory compliance, manufacturing and quality requirements of these systems.
TRUSTED GLOBAL QUALITY SYSTEMS
We designed our quality and security programs with a customer-centric approach. Avantor’s team of skilled technicians offers your team flexibility – and solutions that decrease the complexity around quality, regulatory and security requirements.
Our quality assurance process includes:
- Through our own internal quality assurance team and change control systems we ensure regulatory compliance.
- We help you stay in control of changing situations and minimize risks associated with changes to the manufacturing process with our efficient change notification program.
- We provide complete, consistent, reliable and transparent change notification, proactively.
- Our Critical Materials Care team directly engages with your team and demonstrates, through service level reports, verification of supplies.
- Necessary documents, such as Product Validation, Certificates of Conformance, Quality and Analysis are available either digitally or by request.
- Avantor’s global team of field-based technical experts help you match your project’s requirements with high-quality suppliers of bioprocessing materials.
- Proactive risk-based audits enable us to understand the capabilities of new suppliers and collaborate effectively to promptly address Corrective and Preventative Actions (CAPA) if needed.