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.

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transparent 2D Bag with tubings an filled with blue liqui

Minimize change control and enable “second source” supply

Flex4Sure™ 2D Bags allow storage and transportation of fluids and come in the following configurations: 250ml, 500ml, 1L, 2L, 3L, 5L, 10L, 20L, and 50L.

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.

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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

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.

Flex4Sure™ 3D Bags

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.