BAG SYSTEMS

Flex4Sure™
3D Bag Solutions

Flex4Sure™ 3D Bag Systems incorporate chambers manufactured from INFUFLEX film from Renolit. This co-extruded film has a PE contact layer and offers robustness, a well-characterized extractable profile, high clarity, and excellent chemical resistance. In sizes from 100L to 1000L, Flex4Sure™ 3D Bag Systems are adapted to fit various existing rigid storage totes. The SaniSure® Flex4Sure™ 3D Bags eliminate CapEx for this hardware as they can be integrated quickly into any current process for storage of fluids used in biopharmaceutical manufacturing. Standard Flex4Sure™ 3D Bags are available with Cellgyn® TPE tubing and MPC connectors for rapid delivery or can be integrated into custom assemblies designed to meet your application.

Overview

Flex4Sure™ 3D Bags

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 substance
  • Customized tubing types, sizes, and lengths
  • Manifolds can also be specified for additional process security in critical applications.

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 support containers/totes
  • A wide range of distal connectors (filters, aseptic and hygienic connectors)

Specifications

  • 100L – 1000L – 3-port.
  • All chambers are available in 2 configurations and compatible with market-leading totes
  • Operating Temperature 0 to 60 °C
  • Gamma-ray irradiation sterilization (SAL 10-6)
  • EX Tear Double-layer PE bag vacuum packaging
  • Thickness 0.325 mm offering good flexibility and robustness
  • BPOG Extractables package available on request

COMPLIANCE

  • 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 for film

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The Flex4Sure™ 3D Bags offer supply chain flexibility to pharma manufacturers. Learn how we can create custom assemblies designed to meet your applications.