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Custom Single-Use Assemblies

Custom Single-Use Assemblies

Single-use assemblies are designed to be flexible, efficient and cost-effective in the manufacturing of biopharmaceutical products, including vaccines, antibodies, recombinant proteins, and gene therapy, ensuring that the products are free from the risk of microbial contamination and avoiding the problem of switching between different projects and cross contamination.

Typical Applications of Custom Single-Use Assemblies

  • Buffer and media transfer
  • Collecting samples with zero risk of Contamination
  • Media filtration
  • Carboy assemblies
  • PUPSIT: Pre-Use Post Sterilization Integrity Testing

With 20 years of experience working in the pharmaceutical and biopharmaceutical industries, Cobetter now provides a comprehensive single-use configurator to assist customers in creating their own customized assemblies spanning the entire process of cell culture, formulation, storage, transport, formulation, filling, and packaging.

Tubing Assemblies

-20% Tubing Assemblies

Bags with Filter

-20% Bags with Filter

Multi-Sampling Bags

-20% Multi-Sampling Bags

PUPSIT

-20% PUPSIT
Already have a sketch?
Send us the document and we will be happy to convert it into design, prototype and final custom SUS for your requirements .
Advantages and Benefits
    • Fastest Delivery Time
from concept to products as fast as within 4 weeks
    • Without Minimum Order Quantity
ordering is more flexible
    • Full Customization
create a configuration online or send us your sketch
    • Preassembled, Presterilized
ready to use and big Time-Saver
  • Production in ISO 7 Cleanrooms
Validation Service of Components
Verification and Validation Single-Use Bag Silicone Tubing Fitting Aseptic Connector
Film Specifications ✓ — — —
Connection Strength ✓ — — —
Drop Test ✓ — — —
Heat Seal Strength ✓ — — —
Freezing Test ✓ — — —
Chemical Compatibility ✓ ✓ ✓ ✓
Extractables ✓ ✓ ✓ ✓
TOC, Conductivity and pH ✓ ✓ — —
Particulate Matter ✓ ✓ — ✓
Bacterial Endotoxins Test ✓ ✓ ✓ ✓
Sterility Testing ✓ — — —
Biological Reactivity Test ✓ ✓ ✓ ✓
FDA 21 CFR Indirect Food Additive ✓ ✓ ✓ —
Burst Strength — ✓ — ✓
Vacuum Resistance — ✓ — ✓
Leak Testing ✓ — ✓ ✓
Low Temperature Resistance Test — — — ✓
Barrier Challenge Test — — — ✓
Water Flow Test — — — ✓
Cycle Test — — — ✓
Custom Single-Use Assemblies

Single-use assemblies are designed to be flexible, efficient and cost-effective in the manufacturing of biopharmaceutical products, including vaccines, antibodies, recombinant proteins, and gene therapy, ensuring that the products are free from the risk of microbial contamination and avoiding the problem of switching between different projects and cross contamination.

Typical Applications of Custom Single-Use Assemblies

  • Buffer and media transfer
  • Collecting samples with zero risk of Contamination
  • Media filtration
  • Carboy assemblies
  • PUPSIT: Pre-Use Post Sterilization Integrity Testing

With 20 years of experience working in the pharmaceutical and biopharmaceutical industries, Cobetter now provides a comprehensive single-use configurator to assist customers in creating their own customized assemblies spanning the entire process of cell culture, formulation, storage, transport, formulation, filling, and packaging.
Already have a sketch?
Send us the document and we will be happy to convert it into design, prototype and final custom SUS for your requirements .

Advantages and Benefits

  • Fastest Delivery time: from concept to products as fast as within 4 weeks
  • Without Minimum Order Quantity: ordering is more flexible
  • Full customization: create a configuration online or send us your sketch
  • Preassembled, Presterilized: Ready to use and big Time-Saver
  • Production in our ISO 7 Cleanrooms

Validation Service of Components