Product description
Aseptic single-use sampling assemblies are preconfigured disposable fluid paths designed for the controlled collection, transfer and storage of process samples in pharmaceutical and biotechnology applications.
Configurations range from individual sampling bags from 5 mL to 500 mL to multi-sampling manifold assemblies containing multiple sample bags connected to a common process line. Custom sampling systems can also be developed around the required process interface, tubing, sample receiver and sampling method.
Sampling assemblies can incorporate silicone or TPE tubing, sterile connections, needle-free sampling valves, Luer connections, clamps and other fluid-path components according to the application.
Technical overview
Single-use sampling assemblies allow representative process samples to be collected through a predefined fluid path without repeatedly opening the primary process system.
Individual sampling bags provide a compact solution for collecting and storing one sample. Multi-sampling assemblies connect several sample containers to a common process interface, allowing multiple samples to be collected during different stages of a process or production run.
Standard bag-based configurations provide defined sample volumes and tubing arrangements, while custom assemblies can be developed for applications requiring different sample receivers, process connections, tubing dimensions or numbers of sampling points.
Operating principle
The sampling assembly is connected to the process through a suitable sanitary, sterile or aseptic interface. When a sample is required, the relevant fluid path is opened and process liquid is transferred into the dedicated sample container.
A single sampling bag normally receives one process sample and can then be isolated from the process using the appropriate clamp, valve, tubing disconnection method or connector.
Multi-sampling assemblies use a manifold to distribute the process line to several individual sample bags. Each branch can be opened separately, allowing sequential samples to be collected without replacing the complete sampling assembly.
Needle-free sampling valves can also be incorporated for controlled access to specific sections of the assembly.
Material options
Standard sampling bags use a multilayer bioprocess film suitable for pharmaceutical fluid handling.
The film construction includes:
- ULDPE fluid-contact layer for direct contact with the process sample
- EVOH gas-barrier layer
- Intermediate polymer layers supporting the multilayer film construction
Tubing options include:
- Platinum-cured silicone tubing
- Weldable TPE tubing
- Application-specific tubing for custom assemblies
The final material combination should be selected according to the process fluid, temperature, sampling method, sterilisation requirements and required validation documentation.
Available micron ratings
Not applicable to the sampling assembly itself. Sampling bags and tubing are fluid-handling components and do not have a filtration micron rating.
If sterile filtration, vent filtration or another filtration step is required within the sampling fluid path, an appropriate filter can be incorporated and specified separately.
Design and construction
Sampling assemblies are available as individual sampling bags, multi-sampling manifolds and fully custom sampling configurations.
Individual sampling bags
Standard sample volumes include:
- 5 mL
- 50 mL
- 100 mL
- 250 mL
- 500 mL
Small-volume sampling bags can be configured with one or more hose-barb ports and with silicone or TPE tubing according to the required sampling method.
Standard port options include 1/8" and 1/4" hose-barb connections in single-, double- and three-port layouts.
Small-volume sampling lines
Compact sampling assemblies can use 1/8" ID × 1/4" OD silicone or TPE tubing. A typical 5 mL sampling configuration uses a male Luer Lock connection with a protective plug.
Tubing length and connection technology can be modified where a different distance from the process interface or different sampling method is required.
Multi-sampling assemblies
Multi-sampling assemblies combine several individual sample bags within one manifold and provide a practical solution where multiple samples must be collected from the same process connection.
Standard configurations include:
| Configuration | Sampling bags | Tubing | Additional container |
|---|---|---|---|
| Standard 1 | 10 × 100 mL | 1/4" ID × 7/16" OD TPE | 2 L collection bag with vent filter |
| Standard 2 | 15 × 50 mL | 1/8" ID × 1/4" OD silicone | None |
| Standard 3 | 4 × 250 mL | 1/4" ID × 7/16" OD silicone | None |
Custom assemblies can use a different number of sampling points, sample bag volumes, tubing dimensions or branch arrangements.
Sampling interfaces
Available sampling and process interfaces can include:
- Needle-free swabable valves
- Male and female Luer Lock connections
- Sampling plugs
- Hose barb connections
- Sterile and aseptic connectors
- Quick disconnect couplings
- Sanitary Tri-Clamp interfaces
- Weldable tubing ends
- Custom process connections
Custom sampling assemblies
Where a standard sampling-bag configuration does not match the process, a custom fluid path can be developed around the required process interface and sampling procedure.
Custom configurations can incorporate:
- Different quantities of sampling containers
- Different sample volumes within one assembly
- Bag-based or suitable bottle-based sample collection
- Branched sampling manifolds
- Different tubing materials and dimensions
- Additional clamps and flow-control components
- Sterile connection technology
- Custom labelling and sample identification
Operating conditions
Standard sampling bags are suitable for a recommended operating-temperature range of approximately -80°C to 60°C and a recommended process range of approximately pH 2.5 to 11.
Suitability for the actual process fluid and storage conditions should be confirmed for the final assembly configuration.
Sterilisation and supply condition
Standard sampling assemblies can be supplied pre-sterilised and ready to use following gamma irradiation.
The standard irradiation range is approximately 25–45 kGy.
Configuration-to-order sampling bags can also be supplied non-sterile where the final assembly or sterilisation strategy has not yet been defined.
Sampling bags are individually protected using double-layer PE packaging.
Quality and documentation
Sampling bags and assemblies are produced in controlled cleanroom environments. Exact cleanroom classification depends on the selected configuration and production route.
Available quality and conformity documentation can include:
- USP <788> Particulate Matter
- USP <87> Cytotoxicity
- USP <88> Biological Reactivity
- USP <85> bacterial endotoxin information
- FDA 21 CFR 177–182 material conformity information
- Animal-derived component-free material statements
- TSE / BSE documentation
- Certificate of Analysis / Certificate of Quality
- Integrity-test documentation where applicable
- Gamma sterilisation documentation
- Validation documentation where applicable
Exact conformity documentation should be confirmed for the final sample bag, tubing, connectors and other fluid-contact components.
Typical applications
- Aseptic process sampling
- Closed process sampling
- Bioreactor sampling
- Cell-culture sampling
- Upstream process monitoring
- Downstream process monitoring
- Buffer and media sampling
- Intermediate-product sampling
- Sampling before and after filtration
- Batch sampling
- Multiple time-point sampling
- Quality-control sample collection
- Sample storage and transport
Key benefits
- Defined sample volumes: standard individual sampling bags are available from 5 mL to 500 mL.
- Single and multi-sampling options: one-time sampling bags and multi-point manifold systems can be selected according to the process.
- Closed sampling capability: sterile connection technology and dedicated sampling branches support controlled sample collection from a closed process.
- Multiple tubing options: silicone and weldable TPE tubing are available for different connection and handling requirements.
- Flexible sampling interfaces: needle-free valves, Luer connections, sterile connectors and other interfaces can be incorporated.
- Custom manifold design: the number of sampling points, sample volumes and branch configuration can be adapted to the sampling plan.
- Pre-sterilised options: suitable configurations are gamma irradiated and supplied ready to use.
- Custom engineering: assemblies can be developed around existing process connections, sampling procedures and sample-receiver requirements.
Configuration and quotation
Sampling-system selection should begin with the required sample volume, number of samples and process connection.
For technical configuration and quotation, provide the following information where available:
- Required sample volume
- Number of samples required per assembly
- Single or multi-sampling configuration
- Process application
- Process fluid
- Process connection
- Tubing material
- Tubing ID and OD
- Required branch lengths
- Sampling valve or connector requirement
- Bag-based or bottle-based sample collection
- Operating temperature
- Required sample-storage temperature
- Sterilisation requirement
- Sample-labelling requirement
- Required conformity or validation documentation
- Prototype quantity
- Estimated annual demand
- Existing sampling drawing or process sketch where available
If the final sampling manifold has not yet been defined, the required sample volume, number of sampling points and process connection usually provide enough information for an initial technical review.