Product description
Custom single-use tubing assemblies are preconfigured disposable fluid paths used to connect containers, process equipment, filters, bioreactors and other unit operations in pharmaceutical and biotechnology processes.
Configurations range from simple straight transfer sets to pump tubing sets, Y-line assemblies, reducing transfer lines and multi-branch manifolds. Tubing dimensions, materials, lengths and process connections can be selected around the application.
Common standard tubing dimensions are available for frequently used bioprocess transfer applications, while custom ID, OD, tubing length, connection type and fluid-path geometry can be specified for engineered assemblies.
Technical overview
A single-use tubing assembly combines the required flexible tubing, fittings and process interfaces into one predefined fluid path. Additional components such as sterile connectors, quick couplings, filters, clamps and sanitary connections can be incorporated where required.
Standardised transfer configurations provide a practical starting point for common fluid-transfer applications, while fully custom assemblies can be developed for processes that require different tubing dimensions, branch layouts or equipment interfaces.
Assemblies can be supplied sterile and ready to use or in non-sterile configurations, depending on the selected materials and sterilisation requirements.
Operating principle
The tubing assembly creates a defined fluid path between two or more process points. Liquid is transferred through the flexible tubing using gravity, pressure, a peristaltic pump or another suitable process-driving method.
Straight transfer sets connect two process interfaces directly. Pump tubing sets incorporate a dedicated pump-compatible section for use with peristaltic pumps.
Y-line and manifold assemblies divide or combine fluid streams, while reducing assemblies provide transitions between different tubing dimensions.
Depending on the process, the same assembly concept can also incorporate filtration, sampling, filling or other process components.
Material options
Tubing material is selected according to the process fluid, sterilisation method, pumping requirements, temperature and required connection technology.
Common configurations include:
- Platinum-cured silicone tubing
- Weldable TPE tubing
- TPE tubing with a silicone pump section
- Application-specific tubing materials for custom assemblies
Different tubing materials can be combined within one assembly where required. A typical pump configuration, for example, can use TPE transfer tubing upstream and downstream with a dedicated silicone pump section between them.
Other tubing constructions can be evaluated where the process requires different chemical resistance, pressure capability or temperature performance.
Available micron ratings
Not applicable to the tubing assembly itself. Flexible tubing, connectors and fittings are fluid-handling components and do not have a micron or pore-size rating.
If filtration is required, a suitable process filter can be incorporated into the assembly. Filter membrane material and micron rating are then specified separately according to the application.
Design and construction
Single-use tubing assemblies can be configured from standard transfer-set layouts or engineered around an application-specific fluid path.
Straight transfer sets
Straight transfer sets provide a direct fluid connection between two process points. Common standard tubing dimensions include:
- 1/8" ID × 1/4" OD
- 1/4" ID × 7/16" OD
- 3/8" ID × 5/8" OD
- 1/2" ID × 3/4" OD
Standard transfer-line lengths can include 50 cm, 100 cm and 250 cm. Other tubing dimensions and lengths can be specified for custom assemblies.
Pump tubing sets
Pump tubing assemblies incorporate a pump-compatible tubing section for use with peristaltic pumps. A common construction uses transfer tubing on both sides of a dedicated silicone pump section.
Standard configurations are available in common tubing dimensions from 1/8" ID × 1/4" OD through 1/2" ID × 3/4" OD. Custom pump-section lengths, tubing materials and connections can also be evaluated.
Y-line assemblies
Y-line assemblies provide three fluid-path branches and can be used to divide one process stream into two lines or combine multiple process lines.
Standard Y-line configurations are available in common bioprocess tubing dimensions, with additional larger tubing sizes available for certain sanitary connection configurations.
Each branch can be configured with sterile connectors, quick couplings, sanitary connections or other suitable process interfaces.
Reducing transfer sets
Reducing transfer assemblies connect two different tubing dimensions within one fluid path.
Common standard transitions include:
- 1/8" ID × 1/4" OD to 1/4" ID × 7/16" OD
- 1/8" ID × 1/4" OD to 3/8" ID × 5/8" OD
- 1/4" ID × 7/16" OD to 3/8" ID × 5/8" OD
- 1/4" ID × 7/16" OD to 1/2" ID × 3/4" OD
- 3/8" ID × 5/8" OD to 1/2" ID × 3/4" OD
Other size transitions can be incorporated into custom assemblies where technically suitable.
Manifold and distribution assemblies
Manifold assemblies provide multiple branches from a common process line and can be used to distribute liquid between containers, vessels or other unit operations.
Standard manifold configurations are available, while custom designs can be developed with different tubing sizes, branch quantities, connector types and branch lengths.
Connection technology
Process connections can be selected according to the equipment and fluid-path requirements.
Connection options can include:
- Sterile and aseptic connectors
- Quick disconnect couplings
- Hose barb fittings
- Sanitary Tri-Clamp connections
- Tubing plugs and end closures
- Mechanical tubing-retention clamps
- Overmolded connections
- Custom process interfaces
Sterilisation and supply condition
Suitable tubing assemblies can be supplied sterile and ready to use, non-sterile or configured for subsequent sterilisation depending on the selected materials and components.
Standard sterile transfer-set configurations are available with gamma irradiation in the 25–45 kGy range. For custom assemblies, sterilisation compatibility and irradiation requirements are confirmed according to the complete component configuration.
Production and documentation
Suitable assemblies can be produced and packaged under ISO Class 7 cleanroom conditions.
Depending on the selected components and assembly configuration, available documentation can include:
- Certificate of Conformance
- Certificate of Analysis or Certificate of Quality
- Batch traceability
- USP <87> cytotoxicity information
- USP <88> biological reactivity information
- USP <788> particulate information
- USP <85> bacterial endotoxin information
- BSE / TSE statements
- Material conformity documentation
- Sterilisation documentation where applicable
Exact conformity and validation documentation depends on the tubing, connectors, fittings and other components incorporated into the final assembly.
Typical applications
- Pharmaceutical and bioprocess fluid transfer
- Upstream processing
- Downstream processing
- Media and buffer transfer
- Bioreactor feeding
- Peristaltic pump applications
- Fluid distribution manifolds
- Transfer between single-use and stainless-steel equipment
- Filtration assemblies
- Sterile filtration
- PUPSIT assemblies
- Fill & Finish
- Filling assemblies
- Sampling assemblies
- Container and vessel connections
- Vent tubing assemblies
Key benefits
- Standard and custom configurations: common transfer-set layouts and tubing sizes are available while application-specific assemblies can also be engineered.
- Multiple fluid-path designs: straight transfer lines, pump sets, Y-lines, reducers and manifolds can be configured according to the process.
- Defined tubing dimensions: common bioprocess ID and OD combinations provide a practical starting point for configuration.
- Flexible material selection: platinum-cured silicone, weldable TPE and combined pump-line constructions are available.
- Flexible connection technology: sterile connectors, quick couplings, hose barbs and sanitary interfaces can be incorporated.
- Pump integration: dedicated pump sections can be incorporated for peristaltic pumping.
- Sterile options: suitable assemblies can be supplied gamma sterilised and ready to use.
- Custom engineering: tubing dimensions, lengths, branches and process interfaces can be configured around the actual application.
Configuration and quotation
Select a standard assembly type and tubing size where these match the application. If the required fluid path differs from the standard configurations, specify the required dimensions and process interfaces as part of the assembly request.
For technical configuration and quotation, provide the following information where available:
- Assembly type
- Tubing material
- Tubing ID and OD
- Required tubing length or branch lengths
- Number of branches or ports
- Connection type at each end
- Process fluid
- Required flow rate
- Operating pressure
- Operating temperature
- Peristaltic pump requirement
- Integrated filters or other components
- Sterilisation requirement
- Required conformity or validation documentation
- Prototype quantity
- Estimated annual demand
- Existing drawing, BOM or process sketch where available
A complete engineering drawing is not required to begin. A description of the process together with the required tubing dimensions and connection points is usually sufficient for an initial technical review.