eShop
Sign in
English
That’s why single-use media bottle assemblies have become the preferred solution for media harvest and transfers. These pre-sterilized, ready-to-use bottle systems allow closed-loop, aseptic handling of media and process fluids—without requiring time-consuming cleaning validations or risky manual handling.
What are Single-Use Media Bottle Assemblies?
A single-use media bottle assembly is a pre-configured, pre-assembled, closed transfer system designed to move, sample, or store sterile fluids in bioprocess workflows. Instead of sourcing components separately and assembling them manually, users receive a fully integrated system that’s sterile and ready to connect.
Each assembly typically includes:
- A PETG or PC bottle (125 mL – 2000 mL)
- A 2–3 port threaded cap
- Dip tube for bottom liquid draw
- Pre-attached sterile tubing (TPE or silicone)
- A 0.2 µm hydrophobic vent filter for pressure equalization
These Single-Use Media Bottle Assemblies are gamma-irradiated and delivered with certifications for sterility, biocompatibility, and extractables/leachables —making them ideal for use in regulated environments.
This configuration is often called a vented bottle assembly, PETG media bottle assembly, or closed transfer bottle in industry searches.
Applications of Media Bottle Assemblies
| Bipprocessing Stage | Applications | Features and Benefits |
| Upstream | Medium preparation and storage | Ready-to-use, no need of cleaning validation, reduce cross-contamination risk |
| Inoculation and seed train bioreactor feeding | Easy to operate at a small scale with high flexibility | |
| Downstream | Buffer and reagent preparation | Good chemical compatibility, low temperature resistant |
| Intermediate storage and transfer | Provide a reliable sealed environment for short-term storage, facilitates the material transfer between different processes | |
| Cryopreservation of bulk drug substance | low temperature resistant (-80℃), enable stable, long-term storage | |
| Others | Full-process aseptic sampling | Designed with a needle sampling system that maintains sterility during sampling. |
Why Bottle Assemblies Fit Cell-Culture Media Harvest & Transfers
Every fluid move in upstream processing requires a closed, contamination-free system—especially when dealing with sensitive cell-culture media. Single-use bottle assemblies are designed to meet these requirements while reducing handling steps.Closed, Aseptic Transfer Path
The tubing, dip tube, and vent filter create a sealed, sterile environment. Whether filling, drawing, or transferring fluid, there is no need to expose the system to air. Use sterile tube welders or aseptic connectors to keep your process fully closed.
No Cleaning Validation Needed
Assemblies arrive gamma-sterilized, eliminating the need for washing or autoclaving. That means faster changeovers, reduced utility costs, and lower risk of cross-contamination.
Sized for Media Handling
Common configurations range from 125 mL to 2000 mL, perfect for:
- Shake-flask harvests
- Seed-train inoculum feeds
- In-process sample retains
- QC or stability testing
For larger volumes (>2 L), bioprocessors can seamlessly transition to 2D/3D bags—a topic we’ll cover shortly.
Sterile Venting Prevents Pressure Buildup
Each bottle assembly includes a 0.2 µm hydrophobic vent filter, allowing air to escape during filling and enter during dispensing—without compromising sterility. No need to crack the cap or expose the media to open air.
PETG vs PC: Choosing the Right Bottle Material
Choosing the right bottle material is crucial for maintaining sterility, durability, and compatibility with your media and workflow.
| Property | PETG | PC |
 |
 |
|
| Transparency | Excellent | Moderate |
| Temperate Range | –40 °C to 60°C | –80 °C to 121°C |
| Sterilization Method | Can be sterilized by gamma irradiation at 25-45 kGy | Can be sterilized by gamma irradiation at 25-45 kGy or Autoclaved 1 cycle for 30 minutes at 121°C |
| Durability | High | Very High |
| Typical Use Case | Storage and shipping of culture media and buffers, Storage and shipping of serum, Aseptic transfers, Aseptic sampling. |
Low-temperature storage of vaccines, antibodies, etc. Freeze-thaw and cryopreservation of pharmaceuticals, Product aliquoting, Aseptic transfers. |
PETG process bottles have a service temperature range from –40 to 60 °C and are suitable for the storage and transport of culture media and buffers, as well as for sterile transfer and sampling. In contrast, PC process bottles tolerate –80 to 121 °C and are therefore applicable for low-temperature storage, freeze–thaw operations, and long-term cryopreservation of materials.
Validation & Compliance: What QA/RA Teams Need to See
Today’s QA/RA teams expect comprehensive documentation that demonstrates compliance with international standards. Cobetter’s bottle assemblies are validation-ready, supporting global regulatory and quality frameworks:
- USP <87> In Vitro Biological ReactivityTest
- USP <88> Biological Reactivity Test for Class VI plastics
- Aqueous extraction contains < 0.25 EU/mL, USP <85>
- Particulate matter in USP <788> for large volume parenterals
- Compliant with FDA 21 CFR Part 177-182 (indirect food additives)
- Free of animal-derived components and TSE risk
- ISO 9001:2015 Quality Managrment System
- E&L studies follow BPOG and USP <665> guidelines
When sourcing bottle assemblies, always request documentation to confirm these validation claims. Cobetter provides full COA/COQ packages with each lot, ensuring traceability and compliance.
Why Choose Cobetter for Your Single-Use Media Bottle Assemblies?
Many companies offer Single-Use Media Bottle Assemblies—but few provide the combination of technical performance, documentation, availability, and integration that Cobetter does.
Off-the-Shelf Sizes
From 125 mL to 1000 mL, assemblies are available in PETG or PC, fully sterilized and ready to use.
Validation-Ready Documentation
Each product ships with CoA, CoQ, and supporting documentation for:
- USP <87>/<88>, <788>, <85>, <665>
Tubing & Vent Options
- Weldable TPE tubing for sterile welding/sealing
- Silicone tubing for flexibility and biocompatibility
- 0.2 µm hydrophobic vent filters to maintain sterility
System Compatibility
Cobetter offers tube welders, sealers, and aseptic connectors designed for seamless integration with these assemblies.
Cost-Effective & Scalable
Whether outfitting a lab or scaling a full GMP facility, Cobetter delivers reliable performance—without the premium pricing of Western brands.
Practical Use Cases in Bioprocessing
- Shake-flask harvests: Connect to culture vessel manifold, fill bottles with vent open.
- Seed-train inoculum: Portion sterile media into bottles for timed inoculations.
- QC & retains: Collect samples for sterility, osmolality, pH testing.
- Bridge to bags: Use same tubing/connectors to move from bottle to bag systems.
Fully Customized Services
Cobetter offers a comprehensive range of components to meet the needs of various processes, with nearly all products such as tubing and connectors & fittings manufactured in-house. This ensures rapid response to customer demands, fast order delivery, and provides customers with more convenient customized assembly and connection services.
Single-Use Bottle Assembly Delivery Systems
Conclusion
Single-use media bottle assemblies check every box for modern cell-culture media harvest and transfer:
- Closed and aseptic
- Ready to use
- Sized for real-world workflows
- Compliant with global validation standards
By switching from legacy glass or stainless setups to Cobetter’s single-use systems, your team gains speed, sterility, and scalability—while meeting the demands of QA/RA and global compliance.
So are you ready to optimize your media workflow? Explore Cobetter’s full line of media bottle assemblies or contact our team for customization, specs, or documentation requests.
FAQs
1. What is a single-use media bottle assembly?
A pre-sterilized, closed transfer system that includes a PETG or PC bottle, ported cap, sterile tubing, dip tube, and 0.2 µm vent filter for aseptic fluid handling.
2. Why use single-use bottle assemblies for cell-culture media?
They provide closed, sterile transfers without cleaning validation, making media harvest and transfers faster, safer, and more compliant.
3. What sizes do single-use media bottles come in?
For PETG material, we offer volumes range from 30mL to 1000mL. For PC material, range from 125mL to 2000 mL.
4. What is the difference between PETG and PC bottles?
PETG is clear and compatible with temperatures from –40 to 60 °C. PC process bottles tolerate –80 to 121 °C, making them suitable for low-temperature storage, freeze–thaw operations, and autoclaving.
5. Do Cobetter bottle assemblies come sterilized?
Yes, Cobetter assemblies are gamma-irradiated and shipped sterile, ready for immediate use.
6. Can tubing be sealed for closed transfers?
Yes. TPE tubing can be sterile-welded and sealed, while silicone tubing comes with metallic sleeve for aseptic disconnection.
7. How does the vent filter work?
A 0.2 µm hydrophobic filter equalizes pressure during filling or dispensing while keeping contaminants out.
8. What documentation is provided for QA/RA compliance?
Cobetter provides COA/COQ for the bottle assemblies, along with certifications for sterility, biocompatibility, and extractables/leachables, etc available.
9. When should I switch from bottles to bags?
If transfers regularly exceed ~1–2 L, switching to 2D or 3D bags ensures efficiency while maintaining closed aseptic handling.
10. Why choose Cobetter over other suppliers?
Cobetter offers validation-ready, cost-effective assemblies with global compliance documentation, available in-stock sizes, and compatibility with welders, sealers, and connectors.
