Product description
Custom single-use tubing assemblies are preconfigured disposable fluid paths for pharmaceutical and bioprocess applications. They combine process tubing with the required connectors, couplings, clamps, filters, sanitary interfaces and other components into an application-specific assembly.
Assemblies can be supplied sterile and ready-to-use or as non-sterile tubing systems. The tubing material, connection technology and sterilisation method are selected according to the process requirements and intended operating conditions.
Technical overview
A single-use tubing assembly provides a defined fluid path between process equipment, bags, bottles, filters, bioreactors and other process components. The assembly can range from a simple tubing line with two end connections to a complex manifold incorporating multiple branches and different fluid-path components.
Tubing and components can be selected according to the required process, sterilisation method and existing equipment interfaces. Suitable assemblies can be configured for gamma irradiation or autoclaving, while non-sterile configurations are also available.
Production and packaging take place under ISO Class 7 cleanroom conditions. Components used within the assembly are inspected before cleanroom assembly, and additional cleaning steps can be incorporated where required by the manufacturing process.
Operating principle
The tubing assembly creates a predefined route through which process liquid or gas can move between two or more points in the process. Flexible tubing forms the main fluid path, while connectors, fittings, couplings, filters, clamps or sanitary interfaces provide the required transitions between equipment and disposable components.
A simple assembly may connect a process vessel directly to a bag or bottle. More complex configurations can divide one inlet into multiple outlets, combine several process lines into a manifold or incorporate filtration, sampling and filling functions within the same disposable fluid path.
Because a sterile ready-to-use assembly cannot normally be modified after sterilisation without affecting its controlled condition, connection types, tubing dimensions, component positions and overall layout should be defined during the engineering and specification stage.
Material options
Tubing material is selected according to the process application, fluid compatibility, sterilisation method, pump requirements and operating conditions.
The available assembly concept is not limited to one specific tubing material. Different validated tubing types can be incorporated depending on the process requirement.
Other fluid-path components can include plastic or sanitary fittings, sterile connectors, quick couplings, filters, flanges and additional process components. The material compatibility and conformity of the complete assembly should be evaluated based on the final configuration.
Available micron ratings
Not applicable to the tubing assembly itself. Flexible process tubing does not have a filtration micron or pore-size rating.
Where filtration is required, a suitable filter can be incorporated directly into the tubing assembly. The filter membrane, micron rating and retention specification are then selected separately according to the filtration requirement.
Design and construction
Single-use tubing assemblies are manufactured according to the required fluid path rather than one fixed catalogue configuration. Tubing length, branch layout, connection method and integrated process components can therefore be adapted to the intended application.
Different tubing-to-fitting retention methods can be used depending on the mechanical and process requirements. Configurations range from simple cable-tie retention through mechanical hose-retention clamps to permanent overmolded transitions.
Assemblies can incorporate components such as:
- Flexible pharmaceutical and bioprocess tubing
- Aseptic and sterile connectors
- Quick disconnect couplings
- Sanitary process connections
- Tri-Clamp interfaces
- Filters and vent filters
- Clamps and tubing-retention components
- Manifolds and distribution branches
- Bag and bottle connections
- Bioreactor and vessel interfaces
- Overmolded tubing connections
The exact configuration is determined by the process drawing or specification. Where no existing drawing is available, the fluid path can be developed from the required inlet, outlet and process functions.
Sterilisation and conformity
Depending on the selected tubing and fluid-path components, assemblies can be supplied sterile and ready-to-use, gamma compatible, autoclavable or non-sterile.
Available conformity and production characteristics include:
- USP Class VI
- USP <88>
- cGMP-related production
- Endotoxin statement
- BSE/TSE confirmation
- Irradiation compatibility up to 40 kGy
- Autoclavable configurations
- ISO Class 7 cleanroom production
Final conformity and sterilisation suitability should be confirmed for the complete assembly because individual tubing, connectors, filters and other components may have different operating and material limitations.
Typical applications
Custom single-use tubing assemblies are used throughout pharmaceutical and biotechnology manufacturing where a defined disposable fluid path is required.
- Upstream processing
- Downstream processing
- Fill & Finish
- Media and solution transfer
- Buffer transfer
- Product transfer
- Single-use tubing manifolds
- Fluid distribution systems
- Single-use filtration sets
- Container and bioreactor connections
- Vent tubing assemblies
- Filling assemblies
- PUPSIT assemblies
- Process sampling
Key benefits
- Application-specific configuration: tubing, connections and fluid-path components can be selected according to the required process.
- Ready-to-use fluid paths: suitable assemblies can be supplied preconfigured and sterile for direct integration into the process.
- Flexible connection technology: assemblies can incorporate sterile connectors, quick couplings, sanitary fittings, clamps and overmolded transitions.
- Simple or complex designs: configurations range from basic transfer tubing to branched manifolds, filtration sets and multi-component assemblies.
- Sterilisation options: suitable configurations can be selected for gamma irradiation or autoclaving.
- Component flexibility: different tubing, filters, connectors, couplings and flanges can be incorporated according to the process requirements.
- Cleanroom assembly: production and packaging take place under ISO Class 7 cleanroom conditions.
- Suitable for complete single-use systems: tubing assemblies can connect bags, bottles, bioreactors, filters and other process equipment within one disposable fluid path.
Configuration and quotation
A custom single-use tubing assembly should be specified around the complete fluid path. The most useful starting point is an existing assembly drawing, process sketch or description of the required connections and process functions.
For technical configuration and quotation, provide the following information where available:
- Process application
- Process fluid or gas
- Required tubing material
- Tubing inner diameter and outer diameter
- Required tubing lengths
- Number of branches or manifold outlets
- Required inlet and outlet connections
- Sterile connectors or quick couplings
- Required sanitary or Tri-Clamp interfaces
- Filters or vent filters to be integrated
- Bag, bottle, vessel or bioreactor connections
- Pump application, where applicable
- Operating temperature
- Operating pressure
- Required sterilisation method
- Required conformity documentation
- Annual demand and prototype quantity
- Existing drawing or fluid-path specification, if available
Where a complete specification is not yet available, the assembly can be developed from the process requirements and required connection points.