Single-use bioprocess systems are configurable disposable fluid paths built from process bags, tubing, bottles, connectors, filters and other process components. Filtra supplies custom single-use assemblies for pharmaceutical and biotechnology applications ranging from sampling and media transfer to filtration, product transfer, Fill & Finish and production-scale fluid handling.
Rather than selecting every component in isolation, the complete fluid path can be designed around the process: where the fluid starts, how it moves, whether filtration or sampling is required, which equipment interfaces are needed and how the final assembly must be sterilised, packaged and documented.
A single-use system can range from a simple disposable transfer line to a complete process assembly combining containers, tubing, manifolds, connectors, filters and application-specific components.
Filtra's Single-Use collection brings the core disposable fluid-handling product families together, while individual assemblies can be configured around the exact process.
Configurable 2D and 3D process bags for applications including media handling, buffer preparation and storage, sampling, mixing, cell culture, filtration, transfer and intermediate product storage.
Systems can incorporate tubing, ports, connectors, couplings, filters, process interfaces and other fluid-path components.
Explore Bag Assemblies →Custom tubing systems connect bags, bottles, bioreactors, filters and process equipment within a defined disposable fluid path.
Configurations include transfer lines, manifolds, filtration sets, sampling assemblies, filling assemblies, vent lines, pump tubing and PUPSIT assemblies.
Explore Tubing Assemblies →Bottle, flask, vial and carboy assemblies can be integrated into controlled fluid paths for sampling, transfer, Fill & Finish, buffer and media handling, cell culture, storage and mixing.
Configurations range from simple single-container assemblies to multi-bottle manifold systems.
Explore Bottle Assemblies →A complete single-use assembly is more than a bag or a length of tubing. Each component has a defined role within the fluid path and should be selected around the product, process step, equipment interfaces, sterilisation method and required documentation.
Media handling, feeding, bioreactor connections, sampling and fluid transfer between upstream process steps.
Product transfer, filtration, purification support, intermediate storage and connections between downstream operations.
Preparation, storage, transfer and distribution of process buffers, media and other pharmaceutical solutions.
Single-use bags, bottles and manifolds can form part of controlled sampling systems for development and production.
Capsule filters can be incorporated directly into tubing and container assemblies for liquid, gas, vent and prefiltration applications.
Configurable tubing and container assemblies can connect bulk product, filtration stages and filling equipment.
Tubing assemblies can be configured around pre-use integrity-testing workflows where required by the defined filtration process.
Custom connections, manifolds and containers create a defined route between processing equipment and receiving systems.
Capsule filters combine membrane media and housing within one compact disposable filtration device. This makes them particularly suitable for single-use fluid paths where filtration is required without a separate reusable filter housing.
A capsule can be incorporated directly into a tubing assembly between process containers, upstream of a receiving bag or bottle, as a gas or vent filter or as part of laboratory, pilot and production filtration.
Membrane selection depends on the process fluid and objective: aqueous liquids, protein-sensitive products, gas or vent service, compatible solvents, alcohol-containing fluids or prefiltration all require different consideration.
| Membrane | Typical single-use filtration role |
|---|---|
| PES | Hydrophilic membrane for aqueous liquids, buffers and many pharmaceutical or biotechnology liquid-filtration applications where low protein adsorption is desirable. |
| PVDF | Hydrophilic membrane option for protein-sensitive liquid applications and compatible process fluids. |
| PTFE | Hydrophobic membrane for gas, air, venting and compatible solvent applications. |
| Nylon | Hydrophilic membrane suitable for compatible aqueous and alcohol-containing filtration applications. |
| Polypropylene | Clarification and prefiltration where larger particles should be removed before a finer downstream membrane stage. |
When a membrane filter forms part of a critical pharmaceutical or biotechnology filtration process, integrity testing can be used to verify the filter against defined test parameters and acceptance criteria. The appropriate method depends on the membrane, filter configuration and validated process.
Compact hand-portable integrity tester for flexible testing across laboratories, cleanrooms and production locations. Compatible capsule and other small-format filters can be connected directly.
Test capabilities include Diffusion / Forward Flow, Bubble Point, combined testing, pressure-based testing and Water Flow / Water Intrusion-type testing for suitable membrane systems.
View it-02 →
Wheeled integrity-testing station designed to move between production locations while keeping the test equipment together as a mobile workstation.
The platform supports liquid and gas membrane testing, direct capsule testing and optional automatic membrane wetting.
View ita-02 →These technical resources explain the principal non-destructive membrane integrity-test methods in more detail.
Some bioprocess applications require more than a basic bag-and-tubing assembly. Depending on the process, the fluid path may also require physical protection during freezing or handling, specialised sampling components, process monitoring or additional connection technology.
Single-use processes involving frozen intermediate storage may require additional mechanical protection around the disposable bag. Protection cassettes can form part of a configuration developed around the selected freeze bag and handling process.
Where process monitoring is required, suitable non-invasive components can be considered within the tubing path so selected process conditions can be monitored without unnecessarily interrupting the disposable fluid path.
For pharmaceutical and biotechnology applications, the complete single-use configuration should be reviewed as one system. Bag film, bottle material, tubing, connectors, filters and other product-contact components can each have different operating limits, sterilisation compatibility and supporting documentation.
Applicable single-use assembly families are produced and packaged under controlled cleanroom conditions according to the selected product and manufacturing configuration.
Depending on the selected materials and components, configurations can be developed for gamma irradiation, compatible autoclave processing, sterile ready-to-use supply or non-sterile applications.
Batch traceability and conformity documentation can be supplied according to the components and final assembly specification.
Material declarations and other conformity documentation depend on the selected product-contact components and the finished assembly.
Component documentation should not automatically be assumed to cover every possible finished assembly. Final material compatibility, sterilisation suitability and documentation should be confirmed for the actual configuration.
Single-use systems are valuable where a disposable fluid path, rapid changeover, manufacturing flexibility or reduced dependence on repeated cleaning of reusable process components is desired. Other applications are better suited to permanent sanitary filter housings with replaceable membrane cartridges.
A pharmaceutical facility can therefore use single-use assemblies in one process step and reusable stainless-steel filtration equipment in another. Filtra supports both approaches so the filtration architecture can be selected around the actual process.
| Process requirement | Typical Filtra solution family |
|---|---|
| Disposable fluid path | Single-use bags, tubing, bottles and assemblies |
| Compact disposable filtration | Capsule membrane filters |
| Permanent membrane filtration | Replaceable membrane filter cartridges |
| Reusable sanitary filter system | Sanitary stainless-steel filter housings |
| Critical membrane verification | Filter integrity testing systems |
| Special gas / liquid process components | Porous sintered-metal filters and process components |
A custom single-use system can be developed from an existing assembly drawing, component specification, BOM or simply from a description of the process and required connection points.
Identify the process fluid, process step, required inlet and outlet points, flow conditions, equipment interfaces and filtration requirements.
Define the bag or bottle, tubing, connectors, couplings, filters, sensors and other components required within the fluid path.
Review operating conditions, material compatibility, sterilisation, packaging and required conformity documentation.
Existing designs can be reproduced or modified, while new assemblies can be developed around the required process and connection layout.
If an existing assembly drawing, process sketch, BOM or reference configuration is available, it can be used as the starting point for a replacement or modified assembly.
If no drawing exists, the system can be developed from the required process functions, connection points and operating conditions.
Whether you need a simple tubing line, a process bag, sampling assembly, filtration set or complete multi-component fluid path, start with the process requirement. Filtra can help combine the appropriate container, tubing, connections and filtration components into one configuration.
A single-use bioprocess system is a disposable fluid path built from components such as process bags, bottles, tubing, connectors, couplings, filters and other process components. The assembly is configured around a specific pharmaceutical or biotechnology operation.
Depending on the application, a single-use assembly can incorporate bags, bottles, tubing, manifolds, sterile connectors, quick couplings, sanitary interfaces, capsule filters, vent filters, clamps, sensors and other compatible fluid-path components.
Yes. A suitable capsule filter can be incorporated directly into a tubing, bag or bottle assembly. Membrane material, pore size, filter grade and connections should be selected according to the process fluid and filtration requirement.
The membrane depends on the application. PES is commonly considered for aqueous pharmaceutical and biotechnology liquids, PVDF for protein-sensitive liquid applications, PTFE for gas, vent and compatible solvent applications, Nylon for compatible aqueous or alcohol-containing fluids and polypropylene for clarification and prefiltration.
Yes. Compatible capsule membrane filters can be integrity tested using an appropriate validated method and filter-specific acceptance criteria. The it-02 and ita-02 integrity-testing platforms can be configured for direct capsule filter testing.
Yes. Single-use tubing assemblies can be configured as PUPSIT assemblies according to the filtration layout, connection points and integrity-testing process.
Depending on the selected materials and components, configurations can be supplied sterile and ready to use, configured for gamma irradiation, designed for compatible autoclave processing or supplied non-sterile. Suitability must be confirmed for the complete assembly.
Yes. Single-use bag configurations include 2D and 3D formats with systems available up to approximately 4,000 litres, depending on bag geometry, film construction and the intended process.
A bag assembly uses a flexible disposable process container and can serve applications from sampling to large-volume storage and transfer. A bottle assembly uses a rigid bottle, flask, vial or similar container and is commonly selected for sampling, filling, media handling, cell culture and storage.
Yes. A facility can use single-use bags, tubing and capsule filters for selected process steps while using sanitary stainless-steel housings and replaceable membrane filter cartridges elsewhere. Selection depends on the process and filtration requirements.
Filtra's Single-Use collection brings together the main disposable fluid-handling product families, including configurable bag, tubing and bottle assemblies. More complex systems can be developed as custom assemblies.
Use the Single-Use Assembly Request page and provide the process, fluid, container, tubing, connections, filters, operating conditions, sterilisation requirements and any available drawing, BOM or process sketch.
