Assurance of Quality Supply for Single-Use Solutions
Securing Single-Use Product Availability Resilience
To mitigate supply risks, our Assurance of Quality Supply (AoQS) is based on partnerships, quality agreements, and supply contracts with our suppliers to achieve tight specification and control of our resins, films, and components. The control of our entire supply chain and manufacturing process is the foundation for consistent quality, change control management, and business continuity planning.
We have been securing the availability of single-use products on the market, with extensive plans for increasing our manufacturing and sterilization capacities and the introduction of a multi-sourcing program.
The Challenge
Growing Adoption of Single-Use Solutions in all Process Steps of Commercial Production Requires Enhanced Assurance of Quality Supply
The supply chain for Single-Use Solutions is complex and can impact all 3 components of Assurance of Quality Supply
- Lack of transparency on supply chain & quality systems
- Variability of raw materials
- Demand doubling every 3–4 years with more complex designs
Our Solutions
Consistent Quality | Robust Change | Control Business Continuity
AoQS is Built on Partnership & Relies on the Full Control of Our Entire Supply Chain
- Material science, quality by design (QbD), film extrusion, bag making and product design expertise‘s are the foundations of AoQS
- AoQS is built on partnerships, supply contracts and quality agreements with our suppliers of raw materials, films and components
- AoQS relies on the control of our entire supply chain & manufacturing process from the resins to the final single-use solution
We Lead the Single-Use Industry with Our Level of Control of Resin Formulation and Film Extrusion
Unlike other suppliers, we combine resin specification, extrusion design space & control of the entire process.
Levels of Control | Resins Specification | Resins Control | Extrusion Design Space | Extrusion Control |
|---|---|---|---|---|
S80 & S71 | Yes | Yes | Yes | Yes |
Other Films | Yes | Yes | No | Yes |
No | Yes | Yes | Yes | |
No | No | No | Yes | |
No | No | No | No |
Resin Specifications, Process Controls, & Long-Term Contracts
Resin specification and control
- Resin and additive specification and traceability
- Lot-to-lot consistency of raw materials
Long term contract
- Change management
- Risk mitigation stocks of resins and films
Extrusion design space and control
- Consistent cell growth and robustness
- Lot-to-lot consistency of extractables
- Long-term supply and quality contracts
Long-term supply contracts
- Change management
- Quality specifications
Quality agreements
- Bioburden, particle, and endotoxin
- Extractables characterization
Business continuity plan
- Backup equipment and safety stocks
- Multiple product lines for product families
Multiple manufacturing sites located on four continents
- ISO 7 cleanrooms
- Same quality system allows for resin-to-bag process control
We Offer AoQS with Our Level of Control of Resins and Films...
Consistent Quality
- Our AoQS is the result of building partnerships and establishing quality and supply agreements with critical suppliers
Robust Change Control
- These collaborations help us achieve the specification and control of our resins, additives, and films
Long-Term Business Continuity
- The control of our entire supply chain and manufacturing process is your assurance of consistent quality, change control, and business continuity