Product description
Single-use fluoropolymer freeze bag assemblies are designed for the freezing, storage, transport and handling of pharmaceutical and bioprocess liquids. The fluid-contact bag is manufactured from a single-layer fluoropolymer material and can be configured as part of a disposable fluid path with tubing and connection components.
The combination of chemical resistance, low-temperature flexibility and single-layer construction makes this type of process bag particularly suitable for frozen drug substance, intermediates, cell culture materials and other process fluids requiring controlled storage or transportation.
Technical overview
Unlike multilayer process films constructed from several polymers, adhesive layers and barrier materials, the bag film consists of one fluoropolymer material. This monolayer construction eliminates delamination between film layers and avoids the use of interlayer adhesives within the bag film.
The specified working temperature range is approximately -85 °C to +40 °C. This allows the bag to remain suitable for demanding low-temperature applications where conventional flexible materials may become less elastic.
Assemblies can be supplied for gamma sterilisation and are intended for pharmaceutical and bioprocess applications where cleanliness, material compatibility and controlled fluid handling are important.
Available test and conformity information includes biological safety, endotoxin, particle and extractables data. Extractables and leachables test data following BPOG guidelines can be made available for technical review.
Operating principle
The bag functions as a flexible single-use process container within a closed or controlled fluid path. Process liquid enters or leaves the bag through tubing and connection components selected for the required application.
During freezing, the liquid and flexible container are cooled together. The fluoropolymer film is selected for its ability to remain functional at low temperatures down to the specified operating limit. After freezing, the assembly can be used for controlled storage and subsequent transport before thawing or further downstream processing.
Depending on the configuration, the bag may be supplied as a complete assembly with tubing and connections or as a bag without tubing. The exact fluid path should be defined around the intended filling, freezing, storage, transport and discharge procedure.
Material options
The bag film is manufactured from a single-layer fluoropolymer material.
The monolayer construction does not rely on a combination of PE, EVOH, nylon and adhesive layers commonly used in some multilayer process films. The bag film also does not require plasticisers or colouring additives as part of its stated construction.
Tubing, connectors and other assembly components are configuration-dependent. Required component materials should therefore be specified and verified during assembly selection.
Available micron ratings
Not applicable. This product is a single-use process bag assembly rather than a filtration medium and therefore does not have a micron or pore-size rating.
Where filtration is required within the same fluid path, a suitable filter can be specified separately as part of the complete single-use assembly.
Design and construction
The process bag uses a monolayer fluoropolymer construction and is available in multiple nominal volumes for laboratory, process development and production applications.
Standard listed volumes range from 50 mL to 20 L. Additional 20 mL and 50 L configurations are available on request. Further sizes and assembly designs may also be specified according to the application.
| Nominal volume | Approx. length | Approx. width |
|---|---|---|
| 50 mL | 120 mm | 100 mm |
| 100 mL | 160 mm | 100 mm |
| 250 mL | 240 mm | 100 mm |
| 500 mL | 210 mm | 158 mm |
| 1 L | 285 mm | 178 mm |
| 2 L | 354 mm | 254 mm |
| 5 L | 470 mm | 323 mm |
| 10 L | 570 mm | 383 mm |
| 20 L | 718 mm | 483 mm |
Smaller bag assemblies from 50 mL to 250 mL and larger assemblies from 500 mL to 20 L can be configured with the required fluid-path components. Bags without tubing are also available in non-sterile configurations.
Compliance and technical properties
The available technical documentation for the fluoropolymer bag includes the following stated tests and conformity references:
- USP Class VI
- USP <87>
- USP <88>
- USP <85>
- EP 2.6.14 with stated endotoxin level below 0.125 EU/mL
- ISO 10993-4, non-haemolytic
- USP <661> extractables testing
- USP <788> particle testing
- EP 2.9.19 particle testing
- Cleanroom Class 5 production
- Gamma-sterilisable construction
- Specified working temperature: -85 °C to +40 °C
Exact documentation requirements should be confirmed for the final assembly configuration, including all tubing, connectors and other fluid-contact components.
Typical applications
Single-use fluoropolymer freeze bag assemblies are primarily intended for pharmaceutical and biotechnology processes involving low-temperature storage, fluid handling and product transfer.
- Freezing of pharmaceutical intermediates
- Frozen drug substance storage
- Downstream bioprocessing
- Freezing and storage of cell culture material
- Stem-cell freezing and storage
- Storage and transport of active pharmaceutical ingredients
- Storage and transport of chemically aggressive media
- Storage and transportation of binding media
- Pharmaceutical filling processes
- Critical process sampling
- Low-temperature product transfer
- Intermediate storage before Fill & Finish
Key benefits
- Low-temperature operation: specified for use down to approximately -85 °C.
- Monolayer fluoropolymer film: constructed from a single polymer material rather than a multilayer film system.
- No film delamination: the single-layer construction eliminates delamination between individual bag-film layers.
- Chemical resistance: fluoropolymer construction supports applications involving demanding pharmaceutical and process media.
- Gamma sterilisation: suitable configurations can be supplied for gamma-sterilised single-use applications.
- Clean manufacturing environment: bag production is specified as taking place under ISO Class 5 cleanroom conditions.
- Extractables documentation: test data following BPOG guidelines is available for technical review.
- Multiple process volumes: standard sizes cover small laboratory volumes through larger process-scale assemblies.
Configuration and quotation
Freeze bag assemblies should be specified around the complete process rather than bag volume alone. The required fluid path, storage conditions and connection interfaces determine the final assembly configuration.
For technical selection and quotation, provide the following information where available:
- Required nominal bag volume
- Process fluid or product
- Minimum and maximum operating temperature
- Freezing and thawing procedure
- Required tubing type and dimensions
- Required inlet and outlet connections
- Number of fluid-path ports
- Filling and discharge method
- Gamma sterilisation requirement
- Storage and transport conditions
- Required technical or conformity documentation
- Annual demand and prototype quantity
- Existing assembly drawing or process sketch, if available
Custom configurations and additional bag sizes can be evaluated where a standard assembly does not match the required process.