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

Bioplan

Each change in raw material cost 100,000 €.

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