subscribe
 

Single-use polyethylene bags

2nd June 2014


Sartorius Stedim Biotech, a supplier of the biopharmaceutical industry, is introducing a new, scalable range of single-use bags. The completely new developed product family, 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 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 film, called S80,

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.

Flexsafe ensures 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 400 μm 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 themost 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 additionalapplications such as storage mixing, shipping freeze and thaw will be rolled out step-by-step.





Subscribe

Subscribe



Newsbrief

FREE NEWSBRIEF SUBSCRIPTION

To receive the Scientist Live weekly email NewsBrief please enter your details below

Twitter Icon © Setform Limited
subscribe