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.
Labware and Plasticware
Compare
Flex4Sure™ 3D Bag Solutions
• 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
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)
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