BAG SYSTEMS
Flex4Sure™
2D Bags
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
More in Bag Systems
Looking to simplify change management?
The Flex4Sure™ 2D Bags offer supply chain flexibility to pharma manufacturers. Learn how we can create custom assemblies designed to meet your applications.
