Product description
Custom single-use bottle assemblies are configurable fluid-handling systems that combine a plastic bottle, flask, vial or container with tubing, connectors and other process components. They are used in pharmaceutical and biotechnology applications where liquids need to be sampled, transferred, mixed, filled, stored or handled within a defined fluid path.
Assemblies can range from a simple bottle with one tubing connection to more complex multi-port and manifold configurations. Bottle type, material, volume, tubing layout and connection technology can be selected according to the individual process requirements.
Technical overview
Single-use bottle assemblies provide an alternative to conventional reusable glass bottle systems where cleaning and repeated sterilisation of the container are undesirable. A plastic bottle can be integrated directly into a closed or controlled fluid path and, depending on the selected materials and components, supplied in a configuration suitable for gamma sterilisation.
The bottle acts as the central process container while tubing, filters, connectors, couplings and other components define how product enters, leaves or circulates through the system.
Configurations can be developed for both small-scale laboratory and sampling applications and larger production-scale processes. Large-volume carboys can also be incorporated where increased storage or transfer capacity is required.
Assemblies are batch traceable and can be supplied with a certificate of conformance. Exact certifications and conformity documentation depend on the materials and components selected for the final assembly.
Operating principle
A bottle assembly creates a defined connection between a process container and the surrounding fluid path. Liquid enters or leaves the bottle through tubing and process interfaces integrated into the closure or bottle assembly.
In a sampling application, the bottle can form part of a closed sampling line so that a process sample is transferred directly into the collection container. In transfer or filling applications, the bottle may function as a source or receiving vessel connected to process equipment, filters, pumps or other single-use components.
More complex systems can incorporate several bottles within one manifold. This makes it possible to distribute fluid to multiple containers or connect several collection bottles to a common process line.
The exact operating principle therefore depends on the intended application, number of ports, tubing configuration and integrated components.
Material options
Multiple bottle materials are available to support different pharmaceutical, bioprocess and chemical compatibility requirements.
- Polypropylene (PP)
- Polycarbonate (PC)
- PETG
- PFA fluoropolymer
- ETFE fluoropolymer
- FEP fluoropolymer
Standard polymer bottles are suitable for many general pharmaceutical and biotechnology applications, while high-purity fluoropolymer bottles can be considered where increased chemical resistance, temperature capability or specialised product-contact properties are required.
Certain PFA, ETFE and FEP bottle configurations can also be considered for demanding low-temperature applications, including flash-freezing processes. Suitability must be confirmed for the selected bottle, closure and complete fluid-path configuration.
Tubing, seals, connectors, filters and other assembly components may use different materials. Compatibility and conformity should therefore always be evaluated for the complete assembly.
Available micron ratings
Not applicable to the bottle assembly itself. A bottle assembly is a fluid handling and storage system rather than filtration media and therefore does not have a micron or pore-size rating.
Where venting, particulate filtration or sterile filtration is required, a suitable filter can be integrated into the bottle assembly. The membrane material and micron rating are then specified separately according to the filtration requirement.
Design and construction
Bottle assemblies are individually configured around the application rather than supplied as one fixed design. The container type, material, volume, closure, tubing arrangement and process connections can all be selected according to the required fluid path.
Available container types
Typical bottle and container formats include:
- Standard plastic bottles
- Erlenmeyer flasks
- Vials
- Centrifuge bottles
- PFA bottles
- FEP bottles
- Other fluoropolymer containers
- Large-volume carboys
Assembly configurations
The bottle can be equipped with tubing and additional fluid-path components according to the process requirements. Configurations may include simple single-line bottle systems or more complex multi-port assemblies.
Typical integrated components can include:
- Pharmaceutical and bioprocess tubing
- Sterile or aseptic connectors
- Quick disconnect couplings
- Hose barb fittings
- Sanitary process connections
- Filters and vent filters
- Clamps and flow-control components
- Sampling lines
- Multi-bottle manifolds
Existing assembly drawings can be reproduced or modified, while new systems can be developed from a process description and required connection points.
Sterilisation and conformity
Depending on the selected bottle material and fluid-path components, assemblies can be configured for gamma sterilisation or autoclave processing. Sterilisation suitability must be confirmed for the complete assembly.
Available conformity and production documentation can include:
- FDA CFR 21 material conformity
- USP Class VI <88> Biological Reactivity
- USP <87> Cytotoxicity
- USP <85> Endotoxins
- BSE/TSE statement
- Certificate of Conformance
- Batch traceability
- Gamma-resistant configurations
- Autoclavable configurations
- ISO Class 7 cleanroom manufacturing
- cGMP-related production standards
Certificates and conformity statements can vary according to the selected bottle, tubing and other fluid-contact components and should be confirmed for the final assembly configuration.
Typical applications
Custom bottle assemblies are used throughout pharmaceutical and biotechnology processing wherever a configurable container needs to form part of a defined fluid path.
- Closed process sampling
- Aseptic sampling
- Fill & Finish
- Media fill assemblies
- Buffer storage
- Buffer and media preparation
- Mixing applications
- Cell culture
- Product transfer
- Waste collection and storage
- Multi-bottle manifolds
- Bulk drug substance processing
- Freezing applications
- Intermediate product storage
- Small-scale and production-scale processing
Key benefits
- Custom configuration: bottle type, material, tubing and process connections can be selected around the application.
- Closed fluid-path capability: bottle systems can be configured for controlled sampling, transfer, filling and storage operations.
- Wide container selection: standard bottles, flasks, vials, centrifuge bottles, fluoropolymer bottles and carboys can be incorporated.
- Multiple material options: PP, PC, PETG, PFA, ETFE and FEP provide different process and compatibility characteristics.
- Simple to complex assemblies: configurations range from individual sampling bottles to multi-container manifold systems.
- Single-use processing: disposable plastic bottle systems can reduce dependence on cleaning and repeated sterilisation of reusable glass containers.
- Sterilisation options: suitable configurations can be selected for gamma irradiation or autoclaving.
- Traceability: bottle assemblies are batch traceable and can be supplied with certificates of conformance.
Configuration and quotation
A bottle assembly should be specified around the complete process rather than by bottle volume alone. Container material, process connections, tubing and sterilisation requirements all influence the final design.
For technical configuration and quotation, provide the following information where available:
- Process application
- Required bottle, flask, vial or carboy type
- Required nominal container volume
- Preferred or required bottle material
- Process fluid
- Number of bottle ports
- Tubing material and dimensions
- Required tubing lengths
- Sterile connectors or quick couplings
- Sanitary or hose-barb process interfaces
- Filters or vent filters
- Single-bottle or manifold configuration
- Operating temperature
- Operating pressure, where applicable
- Freezing requirements, where applicable
- Required sterilisation method
- Required conformity and traceability documentation
- Annual demand and prototype quantity
- Existing assembly drawing or process sketch, if available
Where no existing design is available, the bottle assembly can be developed from the application description, required process interfaces and operating conditions.