Single-use quality solutions for biopharma
Manage the quality and risk of your single-use systems by using Avantor’s single-use plastics in medicine, drug discovery, and manufacturing. We adhere to excellence, strict regulatory compliance, and transparent reporting in our supply chain operations.
Why choose Avantor for single-use quality solutions?
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 quality 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 you can trust.
With Avantor as your single-use manufacturing partner, you can be sure that the products you choose meet rigorous quality standards related to component qualification, manufacturing operations, in-process testing, and final product release.
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.
Best practices in the qualification of single-use systems
When we qualify single-use systems, there are multiple best practices we implement to ensure supplies such as single-use assemblies do not affect the quality of research or manufacturing results.
Chemical compatibility tests
As a trusted supplier, we perform all necessary chemical compatibility tests to ensure single-use systems operate as intended. Our results are published and easy to reference when selecting your system components and assemblies.
Gross leak test
All of our single-use quality products are tested for gross leaks to ensure quality and performance standards are upheld during packaging and shipping.
Extractables study
To prevent changes in materials of construction or the manufacturing process, we conduct standardized extractables studies. Our protocol includes a selection of the following:
- Test solvents
- Test articles
- Ratio of surface area to volume
- Pre-sterilization conditions
- Test conditions
- Analytical methods
Quarterly testing
Master systems, along with their components, are tested on a quarterly basis. Any fill and finish applications are subject to an additional test for each lot.
Change management
To help ensure the ongoing qualification of single-use quality systems, we perform science-based assessments whenever there is a change in any of the following:
- Materials of constructions
- Manufacturing processes and sites
- Test methods
These changes are then qualified, and we notify and provide updated qualification documentation to our customers.
Reduce Your Risk and Move Research Forward
Avantor’s single-use quality and regulatory compliance systems help you and your team be sure the single-use assemblies and products you rely on keep your research, scale-up, and production moving forward safely and efficiently.
Our risk reduction resources include:
- Certified ISO (International Organization for Standardization) Class 7 assembly rooms
- Validated equipment and processes that conform to current good manufacturing practices (cGMP)
- Compliant with FDA and EU cGMP requirements
- Robust and timely complaint handling and corrective and preventative actions (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 quality 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’ve designed our quality and security programs with a customer-centric approach. Avantor’s team of skilled technicians offers your team flexibility and solutions that help 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.
- Avantor assures true redundancy through a robust CPFR program — working together early in the process and throughout the design and implementation phase to avoid supply chain disruption. Our critical materials care team directly engages with you to demonstrate, through service level reports, supply verification.
- 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 CAPA if needed.
Learn more about our single-use solutions
Global footprint
Avantor’s single-use design, manufacturing and distribution capabilities are available globally to meet the growing demand for biologics.
Innovation in bioprocessing
Our innovative single-use quality solutions support the scientific journey from drug discovery through scale-up and manufacturing. Learn how single-use assemblies in medicine can help your team mitigate risk.