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
- 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
- Clean Production Environment: ISO Class 4.8 for Final Filling Bags, ISO Class 7&8 for Assembly
| 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 | — | — | — | ✓ |
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
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
