Flex4Sure™ 2D Bags

Flex4Sure™ 2D Bags are 50ml - 50L multi-layer PE pillow bags for the storage and handling of biopharmaceutical process solutions.

The multi-layer co-extrusion film used for the 2D pillow 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. 

Overview
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Benefits

  • Good physical strength, chemical compatibility, and biological compatibility of film materials.
  • Highly transparent film materials for enhanced visual inspection of process fluids.
  • Catering to the needs for storage and transport of various solutions in the biopharmaceutical process.

  • Flexible customisation of configuration allowing precise alignment with application needs. Potential for customised chamber volumes.
  • A wide range of distal connectors (filters, aseptic and hygienic connectors).

 

Applications

  • Storage and transport of small-scale buffers and culture media.
  • Purified component collection.
  • Sample collection and transport.
  • Temporary storage and transportation of bulk intermediates.

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

 

Specifications

  • 2 ports 50-500mL.
  • 3 ports 1-50L.
  • 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<661>: Plastic Containers European Pharmacopoeia tests, Ch.3.1.5.
  • 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