Product description
High-flow genderless sterile connectors are designed for aseptic fluid transfer in pharmaceutical and bioprocess single-use systems. The large-bore connection geometry supports high-volume liquid transfer where conventional small-bore sterile connectors may restrict flow or increase transfer time.
The genderless connection design allows two compatible connector halves to be joined without separate male and female configurations. Hose barb and sanitary Tri-Clamp process connections are available for integration into tubing assemblies, transfer lines and other single-use fluid paths.
Technical overview
These sterile connectors are intended for high-volume biopharmaceutical processes where a secure aseptic connection must be established between two independent fluid paths. They can be incorporated into preconfigured single-use assemblies for product transfer, fluid handling and other sterile processing operations.
The connector housing is manufactured from polycarbonate and incorporates a silicone internal seal. The design is suitable for gamma irradiation as well as autoclave sterilisation, allowing the connection technology to be integrated into different single-use process strategies.
Available technical documentation may include validation information, extractables data and material conformity documentation for use in biopharmaceutical applications.
Operating principle
The connector consists of two compatible genderless halves that are aligned and mechanically joined. During connection, the sterile protective barriers separating the internal fluid paths remain in place until the two connector halves have been correctly mated.
Once the connector halves are secured, the protective membrane barriers are removed together. This opens the internal fluid path while limiting exposure of the sterile connection surfaces to the surrounding environment. The final locking mechanism is then secured to complete the connection.
No separate welding device or additional connection equipment is required for normal operation of the connector.
Material options
The standard sterile connector construction uses the following materials:
- Housing: Polycarbonate
- Internal seal: Silicone
Tubing, process bags, filters and other components connected to the sterile connector may use different materials. Compatibility of the complete fluid path should therefore be verified for the intended process fluid, sterilisation method and operating conditions.
Available micron ratings
Not applicable. This product is a sterile fluid connection device rather than a filtration medium and therefore does not have a micron or pore-size rating.
Where sterile filtration is required, a suitable membrane or capsule filter can be integrated separately into the same single-use assembly.
Design and construction
The connector uses a robust genderless design intended for large-volume pharmaceutical and bioprocess fluid transfer. Both connector halves use the same mating interface, simplifying fluid-path configuration and reducing the need to manage separate male and female connector types.
Available process-side connection configurations include:
| Process connection | Housing material |
|---|---|
| 1" Hose Barb | Polycarbonate |
| 1 1/4" Hose Barb | Polycarbonate |
| 1 1/2" Hose Barb | Polycarbonate |
| 1 1/2" Tri-Clamp | Polycarbonate |
The large-flow-path configuration is intended for processes involving substantial transfer volumes where reducing restriction within the disposable fluid path is important.
Sterilisation and conformity
The connector is suitable for multiple pharmaceutical sterilisation strategies. The stated sterilisation limits include gamma irradiation up to 50 kGy and autoclaving at temperatures up to 130 °C for 60 minutes.
Available conformity and technical documentation includes:
- USP Class VI
- FDA-related material conformity
- No animal-derived ingredients (ADCF)
- Validation documentation available
- Extractables data available
Conformity of the complete single-use system should be confirmed based on all components incorporated into the final assembly.
Typical applications
High-flow sterile connectors are primarily used where two preconfigured bioprocess fluid paths must be connected aseptically while maintaining a comparatively large internal flow path.
- Sterile fluid transfer
- High-volume pharmaceutical liquid transfer
- Single-use bioprocess assemblies
- Upstream processing
- Downstream processing
- Buffer and media transfer
- Bulk drug substance transfer
- Process vessel connections
- Bag-to-bag transfer
- Bag-to-vessel transfer
- Single-use manifolds
- Closed fluid handling systems
Key benefits
- High-flow design: large connection geometry supports high-volume liquid transfer applications.
- Genderless connection: both connector halves use a compatible mating interface, simplifying single-use system configuration.
- Aseptic connection: protective sterile barriers are removed only after the connector halves have been mechanically joined.
- No separate connection equipment: normal connection does not require a tube welder or additional connection device.
- Multiple process interfaces: hose barb and sanitary Tri-Clamp configurations are available.
- Gamma compatible: suitable for gamma irradiation up to the stated maximum dose of 50 kGy.
- Autoclavable: suitable for autoclave processing up to the stated maximum of 130 °C for 60 minutes.
- Single-use assembly integration: suitable for incorporation into custom tubing, bag, bottle and transfer assemblies.
Configuration and quotation
Sterile connectors should be selected as part of the complete fluid-path specification. Connection size, tubing dimensions, process interface, sterilisation method and operating requirements determine the appropriate configuration.
For technical selection and quotation, provide the following information where available:
- Required process connection
- Tubing inner and outer diameter
- Required transfer flow rate
- Process fluid
- Operating temperature
- Operating pressure
- Gamma irradiation or autoclave requirement
- Required conformity and validation documentation
- Whether the connector will be integrated into a complete single-use assembly
- Required quantity or annual demand
- Existing fluid-path drawing or assembly specification, if available
The connector can also be specified as part of a custom single-use bag, bottle, tubing, sampling, filtration or product-transfer assembly.