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Standard Single-Use Manifold Assemblies, Sterile and Ready-to-use, 1 set/pk

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Part No. SAM6TY16KKS01
$183.00 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. For tailored solutions, explore our Custom Single-use Assemblies.

The single-use manifold assemblies consist of:

  • Platinum Cured Silicone Tubing
  • Aseptic Connectors
  • T/Cross Fittings
  • Clamps

Cobetter Single-Use Manifold Assemblies Advantages

  • Full customization, a variety of configurations
  • Fast delivery time and stable supply chain
  • NO Minimum Order Quantity, reduce your inventory
  • Sterile and ready to use, risk-minimizing

 Regulatory Compliance

  • ISO Class ISO 7 cleanroom production (equivalent to GMP Class A cleanliness)
  • ISO 9001:2015 Quality Management System
  • USP<87> Biological Reactivity Test, In Vitro
  • USP<88> Class VI plastics Biological Reactivity Test, In Vivo
  • Bacterial endotoxin meets WFI requirements (< 0.25 EU/mL)
  • Particles matter meet the requirements in CP and USP<788> for large-volume parenterals
  • Gamma radiation dose validation according to ISO11137, sterile packaging

 
Configurations Option
Standard 1 Standard 2
Tubing
STT Platinum Cured Silicone Tubing, 3/8" ID STT Platinum Cured Silicone Tubing, 3/8" ID
Connectors
Lifemeta™ ECS Connectors x 11 AseptiQuik® G Sterile Connectors x 6
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

 
  • 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.