Product description
Custom single-use bioprocess bag assemblies are configurable disposable fluid handling systems for pharmaceutical and biotechnology applications. They can combine a flexible 2D or 3D process bag with tubing, connectors, couplings, filters, ports, sensors and other fluid-path components according to the requirements of the process.
Bag assemblies can be configured for applications ranging from small-volume sampling and media handling to large-volume buffer storage, product transfer, cell culture, filtration and mixing. Available bag formats include both 2D and 3D constructions with nominal volumes up to 4,000 litres.
Technical overview
A single-use bag assembly provides a preconfigured process container and fluid path that can be designed around the intended pharmaceutical or bioprocess operation. The bag geometry, volume, film construction, port positions, tubing arrangement and process connections can be selected according to the required application.
Connections may be positioned on the face or surface of the bag depending on the bag design. Assemblies can incorporate different tubing types, filters, sterile connectors, quick couplings, sanitary interfaces and other process components.
Available configurations include media bags, sampling bags, filtration bags, rocking bioreactor bags, buffer storage bags and recirculation bags. Custom assemblies can also be developed where a standard bag configuration does not match the required fluid path.
Operating principle
The process bag acts as a flexible disposable container within a defined fluid path. Liquid enters and leaves the bag through ports connected to tubing, sanitary fittings, sterile connectors or other process interfaces.
The operating principle depends on the selected bag configuration. A sampling bag may collect a defined sample volume from a process line, while a buffer bag may be used for storage and transfer of larger liquid volumes. A recirculation bag can incorporate a lower outlet and return line so that a pump circulates liquid through the bag for mixing.
Filtration bag assemblies can incorporate an internal filtration mesh or tissue. Process liquid enters the bag and passes through the internal separation medium before being discharged through the appropriate outlet.
Rocking bioreactor bag assemblies are designed to operate on a moving platform. The controlled rocking motion supports fluid movement and cell cultivation, while configurable ports can be provided for media addition, ventilation, sensors and other process connections.
Material options
Different film constructions are available depending on the application, required barrier properties, chemical compatibility and sterilisation method.
Multilayer LDPE process films
LDPE-contact bag constructions are available in several film formats. Depending on the selected construction, additional barrier and protective layers can include EVOH gas-barrier material and nylon reinforcement.
Configurations include standard process films as well as reinforced multi-layer films intended for applications where additional mechanical protection during processing, handling or transportation is required.
Fluoropolymer contact films
Fluoropolymer-contact bag materials can be specified for applications requiring increased chemical resistance or different product-contact characteristics.
PVDF-contact film is available for suitable applications and provides a chemically resistant product-contact surface. Suitable configurations can also be selected for autoclave applications.
The appropriate film material should always be selected according to the process fluid, temperature, sterilisation method, storage conditions and required material documentation.
Available micron ratings
No standard micron rating applies to the general bag assembly. Standard media, sampling, buffer, mixing and bioreactor bags are process containers rather than filtration media.
Filtration bag assemblies can incorporate an internal filtration mesh or separation material. The required mesh or filtration specification is configuration-dependent and should be defined according to the particles, cells, microcarriers or other material that needs to be retained or separated.
If a defined membrane micron rating is required for sterile or particulate filtration, an appropriate inline filter can also be integrated into the complete single-use fluid path.
Design and construction
Single-use bag assemblies are available as both flat 2D bags and three-dimensional 3D process bags. Designs can be configured from relatively simple single-port bags to complex assemblies incorporating multiple tubing lines, manifolds, filters, connectors and process interfaces.
2D bag configurations
2D media bags provide a flat flexible container for media, buffer and general process-fluid handling. Tubing and process connections can be positioned according to the required fluid path.
2D sampling bags can be supplied as individual sample containers or as part of a multi-bag sampling manifold. A sampling manifold typically connects several bags through a common tubing distribution system.
2D filtration bags incorporate an internal separation mesh or filtration tissue. They can be configured with one or more inlet and outlet connections for separation applications.
2D rocking bioreactor bags incorporate attachment points for use on a rocking platform and can include configurable connections for media, ventilation and process sensors.
3D bag configurations
3D buffer bags are intended for larger storage and transfer volumes. Port positions can be configured around the geometry of the support vessel or tank in which the bag will be installed.
3D recirculation bags can incorporate a bottom outlet and return fluid path. When connected to a pump, liquid can circulate from the lower section back to the upper section of the bag to support mixing.
Available volume range
Bag assemblies can be configured in a wide range of volumes with 2D and 3D systems available up to approximately 4,000 litres. The practical volume range depends on bag geometry, film construction, application and supporting equipment.
Packaging, sterilisation and conformity
Depending on the final assembly configuration, available production and conformity characteristics include:
- FDA CFR 21 material conformity
- USP Class VI
- GMP-related conformity documentation
- Endotoxin statement
- BSE/TSE documentation
- Irradiation compatibility up to 40 kGy
- Autoclavable configurations
- ISO Class 7 cleanroom production
- Hydrostatic and tensile-strength testing
- Secure closure of open tubing ends
- Double packaging as standard
Conformity and sterilisation suitability depend on the complete configuration. Bag film, tubing, connectors, filters and other fluid-contact components should therefore be reviewed together when specifying the assembly.
Typical applications
Custom single-use bag assemblies can be configured for a broad range of pharmaceutical and bioprocess operations.
- Bioreactor and cell cultivation processes
- Media preparation and handling
- Buffer preparation, storage and transfer
- Process sampling
- Multi-bag sampling manifolds
- Formulation
- Feed processes
- Waste collection
- Filter wetting and rinsing
- Buffer handling in filling processes
- Rocking bioreactor applications
- Cell and microcarrier separation
- Process fluid mixing and recirculation
- Purification processes
- Product transfer
- Intermediate product storage
Key benefits
- Custom fluid-path configuration: bag geometry, ports, tubing and process connections can be specified around the application.
- 2D and 3D formats: different bag geometries are available for sampling, processing, storage, transportation and large-volume applications.
- Wide volume range: configurations are available from small process and sampling bags through systems with volumes up to approximately 4,000 litres.
- Multiple film constructions: LDPE-contact multilayer films and fluoropolymer-contact options can be selected according to process requirements.
- Integrated fluid-path components: tubing, connectors, couplings, filters, flanges and other components can be incorporated into the complete assembly.
- Application-specific designs: bag systems can be configured for sampling, cell culture, filtration, mixing, buffer storage and other process operations.
- Sterilisation options: suitable configurations can be selected for irradiation or autoclave processing.
- Cleanroom production: assemblies are manufactured under ISO Class 7 cleanroom conditions.
Configuration and quotation
Single-use bag assemblies should be specified around the complete process rather than by bag volume alone. The intended application determines the appropriate bag geometry, film construction, tubing, connection technology and additional fluid-path components.
For technical selection and quotation, provide the following information where available:
- Application or process step
- Required 2D or 3D bag format
- Nominal bag volume
- Process fluid
- Preferred or required bag-film material
- Number and position of inlet and outlet ports
- Tubing material and dimensions
- Required sterile connectors, couplings or sanitary interfaces
- Filters, sensors, valves, clamps or other integrated components
- Operating temperature
- Operating pressure, where applicable
- Required sterilisation method
- Storage and transport conditions
- Required conformity and validation documentation
- Annual demand and prototype quantity
- Existing assembly drawing or process sketch, if available
Where no existing design is available, the assembly can be developed from the process description and required connection points. Existing drawings and component specifications can also be used as the basis for a replacement or modified single-use bag assembly.