BIOTECHNOLOGY 95
Fig. 1. The Flexsafe range of single- use bags initially will be used for validation purposes before being rolled out into other applications.
Single-use equipment comes of age
Single-use equipment such as bags, containers, fermenters, mixers and rectors help to keep production costs down and improve plant flexibility. Sean Ottewell reports.
Les équipements jetables comme les sacs, les conteneurs, les fermenteurs et les réacteurs permettent de maintenir des coûts de fabrication bas et d’améliorer la flexibilité des usines. Un article de Sean Ottewell.
Dank Einwegausrüstung wie Beuteln, Behältern, Fermentern, Mischern und Rektoren können Produktionskosten niedrig gehalten und die Anlagenflexibilität verbessert werden. Sean Ottewell berichtet.
D
emand continues to grow for the single-use (disposable) equipment
used in biopharmaceutical manufacturing. Advantages over traditional stainless steel solutions include the lack of need for cleaning in place procedures – and the associated savings in steam and water – reduced investment costs and better use of space.
One supplier, Sartorius Stedim Biotech, has just introduced its latest offering, a scalable range
of single-use bags. Te Flexsafe product family enables the implementation of single-use bioprocessing throughout all steps of drug manufacture, from process development to production, upstream and downstream – all using just the one innovative polyethylene film.
Sartorius says that 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 multi-layer, 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.
Te company says that this ensures excellent and reproducible cell growth behaviour of the most sensitive cell lines. Te optimisation of the resin formulation, the complete control of raw materials, the extrusion process and the bag assembly together 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. Te bags enable safe and easy-to-use operation, even in the most demanding applications such as liquid shipping and large- scale stirred bioreactors,” notes the company
An added benefit is that 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
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