Product description
Custom single-use bioprocess bag assemblies are configurable disposable fluid-handling systems for the storage, transfer and handling of pharmaceutical and biotechnology process liquids.
Assemblies are available in compact 2D formats for smaller and intermediate volumes and in 3D formats for large-volume storage and transfer. Standard configurations can be selected for common applications, while tubing, connectors, ports, sampling lines, filters and other fluid-path components can be configured around the process.
Standard 2D configurations are available from approximately 250 mL to 50 L, while 3D systems cover large process volumes up to approximately 3,000 L. Custom bag assemblies can be engineered for volumes up to approximately 4,000 L.
Technical overview
A single-use bag assembly combines a flexible process container with the tubing and connections required to introduce, remove, sample or transfer process liquid.
Simple configurations may consist of a bag with two ports, while complete assemblies can incorporate inlet and outlet tubing, sampling lines, sterile connectors, quick couplings, sanitary interfaces, clamps and filtration components.
This allows standard storage and transfer bags to be used where appropriate while retaining the option to engineer the complete fluid path for more application-specific processes.
Operating principle
The flexible bag acts as the disposable process container. Fluid enters and leaves the system through heat-sealed or integrated bag ports connected to tubing and the required process interfaces.
In storage and transfer applications, the bag can receive buffer, media, intermediates, stock solutions or filtered process liquids before subsequent transfer to another process step.
Assemblies with a dedicated sampling line allow process samples to be taken through a separate connection without using the main inlet or outlet line.
Where filtration is incorporated, liquid passes through an integrated capsule filter before entering or leaving the bag, creating a defined filtration and storage fluid path within one preconfigured assembly.
Material options
Several process-film constructions are available depending on the application, required barrier properties, chemical compatibility and handling requirements.
Available film concepts can include:
- Multilayer polyolefin process film with a polyethylene product-contact layer and EVOH gas-barrier layer.
- Reinforced multilayer film incorporating additional mechanical protection for handling and transport.
- ULDPE / EVA / EVOH / LDPE multilayer film for general bioprocess storage and transfer applications.
- PVDF-contact film for applications requiring different chemical or temperature characteristics.
- Fluoropolymer-contact film for specialised fluid-contact requirements.
Tubing can be configured independently of the bag film. Common options include platinum-cured silicone and weldable TPE tubing.
Final film and tubing selection should be based on the process fluid, temperature, sterilisation requirements and required validation documentation.
Available micron ratings
Not applicable to the bag itself. A standard single-use process bag does not contain filtration media and therefore has no micron or pore-size rating.
Filter-integrated bag assemblies can incorporate a separate capsule filter. Standard sterile-filtration configurations are available with 0.2 µm PES membrane filters. Other membrane materials, filtration areas and micron ratings can be selected according to the filtration requirement.
Design and construction
Bag assemblies can be based on standard 2D and 3D configurations or engineered around a custom fluid-path design.
2D storage and transfer bags
Flat 2D bags are suitable for small and intermediate liquid volumes and are commonly used for media, buffer, intermediates and process-liquid storage and transfer.
Common standard volumes include:
- 250 mL
- 500 mL
- 1 L
- 2 L
- 5 L
- 10 L
- 20 L
- 35 L
- 50 L
Port-only configurations are also available where the user intends to define the final tubing and fluid-path assembly separately.
3D large-volume bags
3D bag assemblies are designed for larger process volumes and are typically used together with a suitable support container or handling system.
Available standard and configuration-to-order volumes include:
- 50 L
- 100 L
- 200 L
- 250 L
- 500 L
- 650 L
- 1,000 L
- 1,500 L
- 2,000 L
- 2,500 L
- 3,000 L
Custom engineered bag assemblies can be considered for volumes up to approximately 4,000 L.
Bag ports
Different bag-port arrangements can be selected according to the required number of fluid connections.
Standard hose-barb port sizes can include:
- 1/8" hose barb
- 1/4" hose barb
- 3/8" hose barb
- 1/2" hose barb
- Up to approximately 1" hose barb on suitable large-volume configurations
Two-port and three-port layouts are available for common configurations, while custom assemblies can incorporate additional ports where required.
Tubing and process connections
Bag assemblies can be supplied with platinum-cured silicone or weldable TPE tubing in dimensions selected according to the required flow rate and connection technology.
Available process interfaces can include:
- Sterile and aseptic connectors
- Quick disconnect couplings
- Sanitary Tri-Clamp connections
- Hose barb fittings
- Tubing plugs
- Weldable tubing ends
- Needle-free sampling valves
- Sampling plugs
- Luer connections
Sampling configurations
A dedicated sampling line can be incorporated in addition to the main inlet and outlet connections.
The sampling connection can be configured with a needle-free valve, sampling plug, Luer interface or another suitable connection.
Where a complete multi-sample system is required rather than a sampling connection on a storage bag, a dedicated aseptic sampling assembly should be specified separately.
Filter-integrated bag assemblies
Single-use bags can also be supplied as part of a filtration assembly. These systems combine the process bag with tubing, connections and an integrated capsule filter.
Standard configurations are available with sterilising-grade 0.2 µm PES capsule filters, while alternative filter configurations can be selected for custom assemblies.
Sterilisation and supply condition
Suitable standard storage and transfer bag assemblies can be supplied gamma sterilised and ready to use.
Standard sterile configurations are available with gamma irradiation in the 25–45 kGy range. Other custom film and component combinations may have different validated irradiation limits and should be confirmed for the complete assembly.
Non-sterile configuration-to-order bags are also available where the final assembly or sterilisation strategy has not yet been defined.
Production and documentation
Bag assemblies are available from controlled cleanroom production environments. Exact cleanroom classification depends on the selected production route and assembly configuration.
Depending on the selected materials and components, 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
- FDA material conformity information
- BSE / TSE or animal-derived component statements
- Gamma sterilisation documentation
- Extractables and leachables documentation where available
Exact conformity and validation documentation must be confirmed for the final film, tubing, connectors, filters and other fluid-contact components.
Typical applications
- Buffer storage and transfer
- Media storage and transfer
- Process-liquid collection
- Filtered liquid collection
- Intermediate product storage
- Stock solution storage
- Product transfer
- Downstream processing
- Upstream processing
- Buffer filling
- Waste collection
- Rinsing and filter-wetting applications
- Fluid transfer between unit operations
- Filter-integrated storage assemblies
Key benefits
- Wide volume range: standard 2D and 3D configurations cover applications from 250 mL through 3,000 L, with larger custom assemblies available.
- Standard and custom configurations: common storage and transfer layouts can be selected directly while specialised fluid paths can be engineered around the application.
- Multiple film constructions: different product-contact and barrier materials can be selected according to process requirements.
- Flexible tubing selection: platinum-cured silicone and weldable TPE tubing configurations are available.
- Multiple connection technologies: sterile connectors, quick couplings, Tri-Clamp interfaces and other process connections can be incorporated.
- Sampling capability: separate sampling lines and valves can be integrated where required.
- Filtration integration: suitable capsule filters can be incorporated into the fluid path.
- Sterile ready-to-use configurations: standard assemblies can be supplied gamma irradiated and preconfigured for the intended process.
Configuration and quotation
Select a standard 2D or 3D bag volume where this matches the application. Tubing, connections, sampling lines and additional components can then be configured around the required fluid path.
For technical configuration and quotation, provide the following information where available:
- 2D or 3D bag format
- Required nominal volume
- Process application
- Process fluid
- Required film or material compatibility
- Tubing material
- Tubing ID and OD
- Required tubing lengths
- Number and location of bag ports
- Inlet and outlet connection types
- Sampling-line requirement
- Integrated filtration requirement
- Required filter membrane and micron rating
- Operating temperature
- Required sterilisation method
- Required conformity or validation documentation
- Prototype quantity
- Estimated annual demand
- Existing drawing or process sketch where available
A finished bag drawing is not required to begin. Bag volume, application, process fluid and required connection points usually provide enough information for an initial technical review.