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
- Upstream Processing - Buffer and media preparation, bioreactor feeding, and fluid transfer
- Downstream Processing - Filtration, chromatography, viral clearance
- Final Filling - Sterile fluid transfer, final products handling
- 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: tailored to your process for mixing, storage, fluid transfer and filtration
- Preassembled, Presterilized: ready to use and big Time-Saver
- Clean Production Environment: ISO Class 4.8 for Final Filling Bags, ISO Class 7&8 for Assembly
- Available Configurations: single-Use mixing bags with sensors & tubing; Custom 2D/3D bags with integrated connectors; Fluid transfer sets with filters
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
- Upstream Processing - Buffer and media preparation, bioreacter feeding, and fluid transfer
- Downstream Processing - Filtration, chromatography, viral clearance
- Final Filling - Sterile fluid transfer, final products handling
- 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: tailored to your process for mixing, storage, fluid transfer and filtration
- Preassembled, Presterilized: ready to use and big Time-Saver
- Clean Production Environment: ISO Class 4.8 for Final Filling Bags, ISO Class 7&8 for Assembly
- Available Configurations: single-Use mixing bags with sensors & tubing; Custom 2D/3D bags with integrated connectors; Fluid transfer sets with filters
Validation Service of Components
