New Line of Single-Use Bags Meets Stringent Requirements of the Biopharmaceutical Industry

Flexsafe, which is based on S80, a multilayer, proprietary polyethylene (PE) film, was developed in close collaboration with resin and film suppliers. The PE film is 400 micrometers thick, making Flexsafe one of the strongest and most flexible bags currently on the market.

Optimization of resin formulation, complete control of raw materials quality, the extrusion process, and bag assembly guarantee lot-to-lot consistent cell growth performance of even the most sensitive cell lines.

Flexsafe bags are safe and easy to manage, even for the most demanding applications such as liquid shipping and large-scale stirred bioreactors. Batch-to-batch consistent extractables and leachables profiles, which support drug manufacture throughout all processes from clinical development to commercial supply, guarantee that initial extractable and leachable qualification data will remain valid for every operation involving single-use Flexsafe bioprocess products.

"Flexsafe represents a completely new generation of single-use bags," said Stefan Schlack, senior vice president marketing and product management at Sartorius Stedim Biotech. "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.”

Initially Sartorius Stedim Biotech is launching Flexsafe RM bags (1–200 liters) and small bags for validation purposes. Bags for single use bioreactors BIOSTAT STR (50–2,000 liters) and additional applications such as storage, mixing, shipping, freezing and thawing will be introduced over the coming months.

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