Sartorius Stedim Biotech is introducing a scalable range of single-use bags.
The Flexsafe product 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 just one innovative 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.
The range 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 are designed to guarantee lot-to-lot consistent cell growth performance.
With its robust 400 ?m thick PE film, Flexsafe is claimed to be 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.
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 are assured 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 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.