BAG SYSTEMS

Flex4Sure™
3D Bags

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.

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transparent 3D Bag with tubings

Minimize change control and enable “second source” supply

Flex4Sure™ 3D Bags are available in two chamber configurations compatible with leading totes. The 3D bag chambers come in 100L, 200L, 500L, and 1000L.

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.
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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)
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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
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  • Single-Use Systems (SUS) : Lightweight, plastic Bio-Ease ™ sanitary clamps and gaskets are ideal for securing disposable sanitary process lines without damaging them.
  • Pharmaceutical Manufacturing: Since our plastic Bio-Ease ™ Clamps can be laser-engraved, some companies have found them to be useful for increasing component traceability. The tamper-proof design of our Bio-Ease ™ Clamp fittings also offers increased security. In a high-stakes industry, traceability and security of components used in manufacturing are crucial to regulatory compliance and patient safety.
  • Research Laboratories: Research laboratories in virtually every scientific discipline utilize fluid transfer systems, which require reliable, durable sanitary clamps. Our plastic clamps are available in all standard sizes and are ideal for situations requiring non-metallic or lightweight sanitary fittings. They can withstand up to 150 psi, endure autoclaving at 134° C for up to 5 minutes repeatedly, resist corrosion, and even tolerate Gamma irradiation up to 40kGy. This level of durability and flexibility makes them ideal for a wide range of laboratory setups.
  • Metal-Free Applications: Many operations require non-metallic sanitary fittings and other non-metallic materials to ensure smooth functionality due to various chemical uses, cost factors, required cleaning methods, production requirements, and other considerations.  Bio-Ease ™ Clamps from TBL Performance Plastics, compatible with ASME-BPE and BPSA standards, deliver a reliable solution for these metal-free operations.
  • Single-Use Systems (SUS) : Lightweight, plastic Bio-Ease ™ sanitary clamps and gaskets are ideal for securing disposable sanitary process lines without damaging them.
  • Pharmaceutical Manufacturing: Since our plastic Bio-Ease ™ Clamps can be laser-engraved, some companies have found them to be useful for increasing component traceability. The tamper-proof design of our Bio-Ease ™ Clamp fittings also offers increased security. In a high-stakes industry, traceability and security of components used in manufacturing are crucial to regulatory compliance and patient safety.
  • Research Laboratories: Research laboratories in virtually every scientific discipline utilize fluid transfer systems, which require reliable, durable sanitary clamps. Our plastic clamps are available in all standard sizes and are ideal for situations requiring non-metallic or lightweight sanitary fittings. They can withstand up to 150 psi, endure autoclaving at 134° C for up to 5 minutes repeatedly, resist corrosion, and even tolerate Gamma irradiation up to 40kGy. This level of durability and flexibility makes them ideal for a wide range of laboratory setups.
  • Metal-Free Applications: Many operations require non-metallic sanitary fittings and other non-metallic materials to ensure smooth functionality due to various chemical uses, cost factors, required cleaning methods, production requirements, and other considerations.  Bio-Ease ™ Clamps from TBL Performance Plastics, compatible with ASME-BPE and BPSA standards, deliver a reliable solution for these metal-free operations.

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

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.

More in Bag Systems

Looking to simplify change management?

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

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