Innovative polyethylene film sets new benchmark
Sartorius Stedim Biotech, a leading global supplier to the biopharmaceutical industry, is introducing a scalable range of single-use bags in the Flexsafe family.
The company says Flexsafe enables single-use bioprocessing to be implemented throughout all steps of drug manufacture, from process development to production, upstream and downstream – all using just the one innovative polyethylene film.
Flexsafe is based on a multilayer, proprietary polyethylene (PE) film, called S80, and has been developed in 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.
Flexsafe is said to ensure excellent and reproducible cell growth behaviour 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 robust 400μm thick PE film, Flexsafe is the strongest and most flexible bag currently on the market. The bags enable safe and easy-to-use operation, even in the most demanding applications such as liquid shipping and large-scale stirred bioreactors.
Flexsafe is based on a multilayer proprietary polyethylene film
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.
\'Flexsafe represents a completely new generation of single-use bags. They offer our customers consistent cell growth as well as extraordinary robustness and flexibility. In addition a sustainable supply chain and consistent film throughout the entire manufacturing process is guaranteed. Every single one of these benefits sets a new benchmark. Being unique in all of them makes us very proud,\' said Stefan Schlack, Senior Vice President Marketing and Product Management at Sartorius Stedim Biotech.
Sartorius Stedim Biotech will initially launch Flexsafe RM bags (1L to 200L) and small bags for validation purposes.
Bags for single-use bioreactors Biostat STR (50 to 2,000L) and additional applications such as storage, mixing, shipping freeze and thaw will then be rolled out step by step.