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
Labware and Plasticware
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Flex4Sure™ 2D Bag Solutions
• 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
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)
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