Description
Building on more than 30 years of experience in designing single-use solutions, Sartorius have developed their bioprocessing solutions to be able to support all fluid handling and transportation steps for drug manufacturing.
Flexsafe®2D Pre-Designed Solutions (PDS) have been designed for all storage and sampling of bioprocessing fluids such as media, buffers, harvest & downstream intermediates, drug substances, and drug products.
Assurance of Quality Supply
Our assurance of quality supply and performance is based on the fact that we retain complete control over our manufacturing process, from the resins to the film, the bags, the filters, and the assembly.
This control simplifies change control management and gives our customers a greater sense of security in their purchases.
Cell Growth & Biocompatibility
The establishment of a film extrusion design space along with the optimization of the resin formulation provide the bags with excellent and reproducible cell growth as well as proven biocompatibility. This includes the monitoring of visible particles on weekly representative samples.
E | L Profile
Controls over the variability of raw materials and the manufacturing process ensure consistent and low extractable profiles.
Robustness & Ease of Use
Product robustness is validated throughout the entire design space and proven using a stringent ASTM shipping test. Combining material science and film expertise in partnership with our suppliers, we have selected quality raw materials and optimal extrusion process parameters to obtain consistent robustness.
Assurance of Integrity
The Assurance of Integrity is reached with a combination of tests at both the supplier & at point-of-use levels. Our Supplier Integrity Test (SIT) and FlexAct®BT point-of-use integrity test continue to improve our production of Flexsafe®2D bags, further ensuring the integrity of our product in critical process steps.
