Flexsafe® 2D bags, available in sizes from 20mL to 50L, allow for the storage, sampling, transfer, and shipping of all biopharmaceutical fluids in all process steps. Users can expect quality supply assurance, robustness, closure integrity, biocompatibility, and excellent cell growth performance.

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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.

Applications

  • Application Area
    Liquid storage & shipping  

Materials of Construction

  • Film Material
    Film S80: Polyethylene (PE)  

Product Information

  • Bag Type
    2D storage & shipping bag  
  • Brand
    Flexsafe® 2D  

Sterility/Purity

  • Delivery Condition
    Sterile