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Sartorius Stedim Biotech launches new single-use bag family Flexsafe
Sartorius Stedim Biotech is introducing a scalable range of single-use bags. This Flexsafe family enables the implementation of single-use bioprocessing throughout all steps of drug manufacture, from process development to production, in upstream and downstream – all using one polyethylene film. The 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 standardised cell growth assay has been used to optimise film formulation, determine the operating ranges for extrusion, welding and gamma-irradiation processes and to establish specifications and process controls.
According to Sartorious, Flexsafe ensures excellent and reproducible cell growth behavior of the most sensitive cell lines. The optimisation 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 400 μm thick PE film, Sartroius claims Flexsafe is the strongest and most flexible bag currently on the market. It enables safe and easy-to-use operation, even in the most demanding applications such as liquid shipping and large-scale stirred bioreactors.
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, says Sartorious, that their initial extractable and leachable qualification work and data remain valid every time they operate their single-use Flexsafe bioprocess.