BAG SYSTEMS

Flex4Sure™
2D Bag Solutions

Flex4Sure™ 2D 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 250ml to 50L, Flex4Sure™ 2D Bag Systems are well suited for storing and transporting fluids used in biopharmaceutical manufacturing. Standard Flex4Sure™ 2D 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™ 2D Bags

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

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 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)

Specifications

  • 250ml -50L; 3-ports
  • Operating temperature 0 to 60 °C
  • Gamma-ray irradiation sterilization (SAL 10-6)
  • EZ Tear Double-layer PE bag vacuum packaging
  • Film 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™ 2D Bags offer supply chain flexibility to pharma manufacturers. Learn how we can create custom assemblies designed to meet your applications.