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Standard Single-Use 2D Bag Assemblies with Capsule Filter, Sterile and Ready-to-use

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Part No. B2D05LT21X10
$204.00 USD
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*Not for medical use

Lifecube™ single-use 2D bag assemblies with filter are sterile, pre-assembled systems designed for fluid handling in biopharmaceutical and life sciences applications. The single-use bag assemblies integrate a filtration unit, ensuring aseptic processing while eliminating cross-contamination risks. For tailored solutions, explore our Custom Single-use Assemblies.

Bag Assemblies with Topene™ Film

Cobetter Topene RB blown film designed for biological processes is composed of ULDPE (ultra-low density polyethylene), EVA (ethylene-acetic acid ethylene copolymer), EVOH (ethylene-vinyl alcohol copolymer) and LDPE (low density polyethylene). Cobetter Lifecube™ 2D bioprocess bags are available in 1, 2, 5, 10, 20, 35 and 50 L sizes.

Tubing

Available in both Pt-cured Silicone and TPE (thermoplastic elastomer) tubing.

Inlet and outlet Connectors

Multiple types and sizes of connectors are available, including ECS Connector, Aseptic Connector, TC, and Plug.

Sampling Port

Needle-free swabable valve, sampling plug, male and female Lure Lock.

Capsule Filter

Cobetter Bricap™ C / L / T series sterilizing-grade filters.

Cobetter Bag Assemblies Advantages:

  • Reduced Contamination Risk: Pre-sterilized and ready-to-use, eliminating cleaning validation
  • Cost-Efficient: Lower cost (no CIP/SIP systems) and reduced downtime
  • Scalability: from R&D to commercial production
    Regulatory Compliance: Meets cGMP, USP Class VI, and FDA standards.
  • Flexibility: Compatible with single-use bioreactors and downstream equipment.

Regulatory Compliance

  • ISO 9001:2015 quality management system
  • ISO Class 4.8 / ISO 7 cleanroom production
  • ADCF raw materials, complies with FDA 21 CFR Part 177-182(Indirect food additives)
  • Meet the requirement of current USP <87> Class VI, Biological Reactivity Test, In Vitro
  • Meet the criteria of current USP <88> Class VI, Biological Reactivity Test, In Vivo
  • Aqueous extraction contains <0.25 EU/mL as determined by Limulus Amebocyte Lysate (LAL), USP <85>
  • Particulate matter in the product eluent meets the requirements in USP <788> for large volume parenterals
  • Verified gamma irradiation dose according to ISO® 11137
Configurations Option
Standard 1 Standard 2
Single-Use Bags
5L 2D Bag with 1/4"-1/4"-1/4" Ports 50L 2D Bag with 3/8"-1/4"-3/8" Ports
Tubing
STT Platinum Cured Silicone Tubing, 1/4" ID STT Platinum Cured Silicone Tubing, 3/8" ID
Capsule Filters
Bricap™ C02 with 0.2 μm PES, Filtration Area: 420cm² Bricap™ C03 with 0.2 μm PES, Filtration Area: 660cm²
Sterility Delivery Condition Sterile
Sterilization Method Gamma irradiation at 25–45 kGy
Package Packaging Individually packaged in double PE bags
Pack Size 1 set /pk

 
  • 7_Cobetter_Lifecube_2D_5L_Single-Use_Bag_with_Capsule_Filter_-_Standard_Configuration_I Download
  • Cobetter_Lifecube_SA_Single-Use_Assemblies_Catalog_250710 Download
Cobetter’s custom tubing assemblies are non-sterile, can customers sterilize it by themselves?

Yes, user can sterilize only the tubing assemblies and the connectors, excluding any bags.

When user sterilize the connectors and tubing, all ports should be opened, such as connector plugs and blind caps on clamps. After sterilization is completed, they can be connected and used.

Attention: You will need to add an additional cable tie to offset the leakage risk caused by the high-temperature deformation of the original cable tie after off-line sterilization.

Can Cobetter self-developed tubings be used for organic solvent solutions?

Both Pt-cured silicone tubing (STT, ST5P, ST8H) and TPE tubing (STF) are resistant to organic solvents. For certain solvent resistance, please refer to the chemical compatibility section in the validation guidelines.

Are the integrity testing of bags and tubings conducted together?

The pressure resistance of the bags and tubings is different. For the bag, we apply an air pressure of around 0.015 bar or 0.02 bar after clamping with bag clamps. After a certain period, we measure the pressure decay. The tubing and fittings can withstand pressure of up to approximately 2 bar, and we apply a pressure of 1.6 or 1.7 bar to measure the pressure decay.

How do the drawings correspond to the product packaging?

Each product shown on a drawing represents the product within one package. If separate packaging or simultaneous use of multiple products is required, they can be split/integrated into a single drawing.