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Single-Use Technology Sartorius Stedim Biotech Launches New Single-Use Bag Family

| Editor: Dr. Jörg Kempf

Sartorius Stedim Biotech, a leading global supplier of the biopharmaceutical industry, is introducing a brand-new, scalable range of single-use bags.

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Flexsafe enables the implementation of single-use bioprocessing throughout all steps of drug manufacture, from process development to production, in upstream and downstream – all using just the one innovative polyethylene film.
Flexsafe enables the implementation of single-use bioprocessing throughout all steps of drug manufacture, from process development to production, in upstream and downstream – all using just the one innovative polyethylene film.
(Picture: Sartorius)

The innovative concept of the Flexsafe family addresses key industry requirements for future-proof single-use manufacturing of commercial vaccines and drugs. Flexsafe is based on a multilayer, proprietary polyethylene (PE) film, called S80, and has been developed in close collaboration with resin and film suppliers. A standardized cell growth assay has been used to optimize film formulation, determine the operating ranges for extrusion, welding and gamma-irradiation processes and to establish specifications and process controls.

Flexsafe ensures excellent and reproducible cell growth behavior of the most sensitive cell lines. The optimization of the resin formulation, the complete control of raw materials, the extrusion process and the bag assembly guarantee lot-to-lot consistent cell growth performance. With its robust 400 μm thick PE film, Flexsafe is the strongest and most flexible bag currently on the market, the company says. The bags enable safe and easy-to-use operation, even in the most demanding applications such as liquid shipping and large-scale stirred bioreactors.

Furthermore, batch-to-batch consistent extractables and leachables profiles support drug manufacturers throughout the entire lifecycle of modern biological treatments from clinical development to commercial supply many years after launch. Users can gain assurance that their initial extractable and leachable qualification work and data remain valid every time they operate their single-use Flexsafe bioprocess.

Assurance of supply, one of the most important aspects for manufacturers, is guaranteed as a result of long-term contracts with suppliers and business continuity plans with defined safety stocks and global manufacturing capabilities including resin manufacturing.

Sartorius Stedim Biotech is launching Flexsafe RM bags (1L-200L) and small bags for validation purposes first. Bags for single use bioreactors Biostat STR (50-2000L) and additional applications such as storage, mixing, shipping freeze and thaw will be rolled out step by step.

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