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Standard Single-Use Multi-sampling Bag Assemblies, Sterile and Ready-to-use

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Part No. BAS010XCPF01
$520.00 USD
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*Not for medical use

With a wealth of expertise in single-use technology, Cobetter offers a variety of configurations of single-use manifold assemblies, which are pre-designed and ready to use. The single-use manifold assemblies can be attached to any device with aseptic connector options for the sterile liquid transfer. Looking for a complete solution? Explore our Single-Use Assemblies, with custom configurations available to match your process requirements.

The single-use multi-sampling bag assemblies consist of:

  • 50-500mL sampling bags
  • 2 L collection bag
  • TPE Tubing
  • Needle-free Swabable Valve

Cobetter Single-Use Multi-Sampling Bags Advantages

  • Flexibility: Customer can change the configuration for project needs
  • Fast Lead Time: Faster than fully custom solutions
  • Scalability: Easy to adapt for different production scales
  • Reduced Inventory: Configure as needed rather than stocking assemblies

Quality Standards

  • ISO 9001: 2015 Quality Management System
  • ISO 4.8 / ISO 7 / ISO 8 cleanroom production
  • Manufactured for use in conformance with cGMP
  • Each product is integrity tested prior to release
  • COA/COQ provided with shipment
  • Validation documents are available upon request
  • TSE/BSE certificate available
Physical Properties Product Name Lifecube™ Multi-sampling Bag Assembly
Sampling Bag Standard 1: 10 x 100 mL Sampling Bags
Standard 2: 15 x 50 mL Sampling Bags
Standard 3: 4 x 250 mL Sampling Bags
Collection Bag Standard 1: 2 L Single-use Bag with vent filter
Standard 2: /
Standard 3: /
Tubing Size Standard 1: 1/4" ID x 7/16" OD
Standard 2: 1/8" ID x 1/4" OD
Standard 3: 1/4" ID x 7/16" OD
Materials Film Material Topene™ RB film
Tubing Material Standard 1: TPE (Lifemeta™ STF)
Standard 2: Silicone (Lifemeta™ STT)
Standard 3: Silicone (Lifemeta™ STT)
Connections Sampling Line Needle-free swabable valve
Regulatory Compliance Compliance USP <788> Particulate Matter
USP <87> Cytotoxicity
USP <88> Biological Reactivity
FDA Indirect Food Additives, 21 CFR 177-182
ADCF Materials
Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
Sterility Delivery Condition Sterile
Sterilization Method Gamma irradiation at 25–45 kGy
Package Pack Size Pack of 1
Packaging Individually packed in double PE bag

 
  • 1_Cobetter_Lifecube_AS_Multi-sampling_Bags_-_Standard_Configuration_I Download
  • Cobetter_Lifecube_SA_Single-Use_Assemblies_Catalog_250710 Download
What tests are typically performed on Cobetter single-use bags prior to release?

A Certificate of Quality is provided with each shipment, listing routine test items and applicable reference standards. These tests include bag integrity, endotoxin levels, sterility, and insoluble particulate matter, among others.

What is the role of the adhesive layer in the film material?

The fluid-contact inner layer of the bag is made of ULDPE (ultra-low-density polyethylene), a non-polar material. The gas-barrier layer is composed of EVOH (ethylene–vinyl alcohol copolymer), which is a polar material. According to the principle of ‘like dissolves like,’ these two materials cannot be directly bonded.

An adhesive layer is therefore used as a transition layer. This layer is made of PE (polyethylene) blended and modified with partially vinyl functional groups, enabling effective bonding between the two materials.

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.