SIMPLIFIED CHANGE MANAGEMENT
Flex4Sure™ has been developed to offer supply chain flexibility by leveraging a RENOLIT INFUFLEX 9101 ULDPE Film in its construction. By integrating
this film into Flex4Sure™ Bags, change management is simplified and the bag chambers have been designed
to fit Into existing hardware, which eliminates Capex costs.

Bag in business!

When your bags run out,
the best second supplier is SaniSure.
Flex4Sure™
BAG FILM
  • RENOLIT INFUFLEX 9101 ULDPE Multi layer co-extruded film.
  • Available from multiple bag suppliers.
  • Extrusion lines in North America, Europe and Asia.
  • Safety stock for RENOLIT film.
Flex4Sure™
SUPPLY SECURITY
  • Select chamber volumes in stock.
  • In house component manufacturing.
  • Safety stock of critical components.
  • Three assembly sites: two North America, one Europe.
Flex4Sure™
EASE OF IMPLEMENTATION
  • Engineered to fit market leading totes.
  • Vendor independent components selection.
  • Prototyping.
  • Customized chamber dimensions and port configurations.

2D BAGS

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. With this film, they can be safely used for the storage and transportation of various biopharmaceutical liquids.

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3D BAGS

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.

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2D BAGS
  • 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 customization of configuration allowing precise alignment with application needs. Potential for customized chamber volumes.
  • A wide range of distal connectors (filters, aseptic and hygienic connectors).
3D BAGS
  • 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).

Specifications & Application

 
2D BAGS
  • 250ml – 50L – 3-port.
  • Operating temperature 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.
 
3D BAGS
  • 100L – 1000L – 3-port.
  • Operating Temperature 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.

Locations
  • Europe
  • ZAE Robert Steichen
  • 16, rue Héierchen
  • L4940 Bascharage
  • Grand Duché du Luxembourg
  • Americas
  • 1020 Flynn Road
  • Camarillo, CA 93012
Phone
TRY OUR Flex4Sure™ BOTTLES & PROPRIETARY DELIVERY SYSTEM WITH YOUR VACCINE OR DRUG