Flex4Sure™ 3D Bags

Flex4Sure™ 3D Bags are 100-1000L multi-layer PE ‘bag in box’ for the storage and handling of biopharmaceutical process solutions.

The multi-layer co-extrusion film used for the 3D bags ensures minimized gas permeability, good physical strength, and wide chemical compatibility and biocompatibility of the aseptic storage bags, so that they can be safely used for the storage and transportation of various biopharmaceutical liquids. The standard 3D bags are available in chamber volumes from 100L - 1000L and can be used with a corresponding rigid tote for storage of buffers, culture media, intermediates, or drug substances. Luer connectors, CPC quick connectors, sanitary Tri-clamp connectors, or sterile connectors are available for inlet and outlet tubing and filter capsules to ensure compatibility with upstream and downstream process equipment. A variety of sampling tools can be used, such as needleless samplers, Luer female connectors, and medical heparin caps.

Overview
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Benefits

  • Highly transparent film materials for enhanced visual inspection of process fluids.
  • Flexible customization of sizes, tubings, joints, and filters for a variety of biopharmaceutical processes.

  • Simplify implementation with chambers that are compatible with a variety of cubical support containers/totes.
  • A wide range of distal connectors (filters, aseptic and hygienic connectors).

 

Applications

  • Storage and transport of buffers and culture media.
  • Transport of harvested cell culture fluids.
  • Purified component collection.
  • Filtration and storage of intermediates.

  • Storage and transport of drug substances.
  • Customised tubing types, sizes and lengths.
  • Manifolds can also be specified for additional process security in critical applications.

 

Specifications

  • 100L – 1000L – 3-port.
  • Operating Temperature −80 to 60 °C.
  • Gamma ray irradiation sterilization (25-40 kGy).
  • Double-layer PE bag vacuum packaging.
  • Thickness 0.325 mm.
  • ISO 10993-4: Hemolysis.
  • ISO 10993-5: Cytotoxicity.

  • ISO 10993-6: Implantation test.
  • ISO 10993-10: Irritation and Sensitization tests.
  • ISO 10993-11: Acute Systemic Toxicity test.
  • USP<85>: Bacterial Endotoxins-LAL test on request.
  • USP<88>: Biological reactivity testing, in vivo, class VI.
  • USP<661>: Plastic Containers European Pharmacopoeia tests, Ch.3.1.5.
  • ADCF: No animal derived ingredients.

 

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SaniSure, Inc. Main Office
1020 Flynn Road
Camarillo, CA 93012
877.777.3005 Toll Free
805.465.5600 Local