Product description
Custom single-use filling assemblies are preconfigured disposable fluid paths designed for aseptic transfer and final filling of pharmaceutical and biopharmaceutical products.
A typical filling assembly combines a sterile filling bag with pump tubing, aseptic process connections and one or more disposable filling needles. Standard configurations are available with 3 L and 5 L filling bags and between 1 and 12 filling needles, while the complete fluid path can be adapted to the filling process.
Filling assemblies can be configured for applications involving monoclonal antibodies, vaccines, recombinant proteins, gene therapies, blood products and other liquid pharmaceutical products.
Technical overview
The filling bag acts as an intermediate product reservoir between the upstream process and the filling machine. Product enters the bag through an aseptic process connection and is transferred through dedicated pump tubing to one or more filling needles.
The complete assembly can be supplied preassembled and gamma sterilised, reducing the need to assemble individual tubing, connectors, bags and filling needles at the point of use.
Standard filling-bag systems provide a defined starting configuration, while tubing dimensions, inlet connections, number of filling lines, needle size and other process interfaces can be configured according to the required filling machine and dosage range.
Operating principle
Bulk product is transferred into the single-use filling bag through the inlet line. The bag functions as a temporary sterile reservoir immediately upstream of the filling operation.
Product is then transferred from the bag through dedicated pump tubing. A peristaltic filling pump can control the volume delivered through each filling line without introducing a reusable pump component into the product-contact path.
Each filling line terminates in a disposable filling needle. Needle internal diameter is selected according to the required filling volume, product properties and filling-machine configuration.
Assemblies can use a single filling needle or multiple parallel filling lines where the equipment supports multi-head filling.
Material options
Filling assemblies combine several product-contact materials selected according to their function within the fluid path.
Standard configurations can include:
- Multilayer bioprocess film for the disposable filling bag
- Platinum-cured silicone pump tubing for controlled peristaltic filling
- 316L stainless steel for the product-contact section of suitable disposable filling needles
- Polysulfone (PSF) in suitable filling-needle components
- Polymer aseptic connectors and fluid-path fittings according to the selected assembly
Alternative tubing and connection materials can be evaluated where required by chemical compatibility, process conditions or an existing filling-machine specification.
Available micron ratings
Not applicable to the filling assembly itself. Filling bags, tubing and filling needles are fluid-transfer components and therefore do not have a filtration micron rating.
A vent filter can be incorporated into suitable filling-bag configurations. Where sterile product filtration is required upstream of final filling, the required sterilising-grade filter can be specified separately as part of the complete single-use fluid path.
Design and construction
Single-use filling assemblies can be based on standard filling-bag configurations or developed as a customised final-filling fluid path.
Filling bag volumes
Standard filling bags are available in:
- 3 L
- 5 L
Other bag volumes can be considered for custom filling assemblies where the standard reservoir volumes do not match the batch size or filling equipment.
Number of filling lines
Standard filling bags can be configured with between 1 and 12 filling needles.
The number of filling lines should be selected according to the filling machine, number of pump channels, required throughput and container format.
Filling needle sizes
Disposable filling needles are available in several internal diameters to support different dosage volumes.
| Needle ID | Needle OD | Reference filling volume | Reference accuracy |
|---|---|---|---|
| 0.6 mm | 2.0 mm | >0.1 mL | ≤2% |
| 1.2 mm | 1.7 mm | >0.5 mL | ≤1% |
| 1.6 mm | 2.1 mm | >1.5 mL | ≤1% |
| 2.1 mm | 2.8 mm | >3 mL | ≤1% |
| 3.0 mm | 3.8 mm | >5 mL | ≤1% |
| 3.8 mm | 4.6 mm | >10 mL | ≤1% |
| 4.6 mm | 6.2 mm | >30 mL | ≤1% |
| 5.5 mm | 8.6 mm | >50 mL | ≤1% |
These accuracy figures are reference values obtained from laboratory filling tests using WFI. Actual filling accuracy depends on the complete filling system, pump configuration, fluid characteristics, process parameters and equipment settings.
Filling needle design
Available needle configurations include hose-barb and straight-end connection designs depending on needle diameter and filling-system layout.
The product-contact needle section is manufactured from 316L stainless steel. Filling is designed to take place from the bottom upwards, supporting controlled liquid dispensing into the receiving container.
Pump tubing
Platinum-cured silicone pump tubing can be incorporated between the filling bag and disposable needles for use with peristaltic filling pumps.
Tubing dimensions and length should be selected according to the filling machine, pump head, filling volume, required accuracy and number of filling lines.
Bag ports and connections
Filling bags can use low-residual-volume bag-port designs to support efficient product recovery.
Available process interfaces can include:
- Aseptic inlet connectors
- Tubing ports
- Low-residual bag ports
- Dispensing connections
- Optional vent filtration
- Custom process interfaces
Integration with filling equipment
Filling-bag and needle configurations can be adapted for integration with different pharmaceutical filling-machine platforms.
The required bag geometry, hanging-hole position, number of filling lines, tubing routing and needle dimensions should therefore be specified according to the actual filling equipment.
Sterilisation and supply condition
Standard filling-bag assemblies are supplied sterile following gamma irradiation in the 25–45 kGy range.
Filling bags are individually protected in double PE packaging.
Disposable filling needles are available either pre-sterilised by gamma irradiation or non-sterile for suitable steam sterilisation.
Suitable non-sterile needle configurations can be autoclaved for up to approximately 90 minutes at 135°C.
Quality and documentation
Filling-system related products are produced in a controlled ISO Class 4.8 cleanroom environment. The filling bags are integrity tested before release.
Available 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
- Gamma sterilisation documentation
- Extractables and leachables support where applicable
- Chemical-compatibility evaluation where applicable
Exact documentation depends on the final bag, tubing, needle, connector and fluid-path configuration.
Typical applications
- Aseptic final filling
- Monoclonal antibody filling
- Recombinant protein filling
- Vaccine filling
- mRNA product filling
- Cell and gene therapy filling
- Liquid injectable product filling
- Blood-product filling
- Pre-lyophilisation filling
- Sterile bulk drug substance transfer
- Small-volume pharmaceutical filling
- Multi-head filling processes
Key benefits
- Complete disposable filling fluid path: bag, tubing, process connections and filling needles can be supplied as one configured system.
- Multiple filling lines: standard configurations support between 1 and 12 disposable filling needles.
- Defined needle sizes: multiple needle diameters support a broad range of filling volumes.
- Peristaltic pump compatibility: platinum-cured silicone pump tubing can be integrated for controlled filling.
- Low residual volume: suitable bag-port configurations are designed to reduce retained product after filling.
- Equipment-specific configuration: bag geometry, tubing, hanging position and filling lines can be adapted to the filling-machine layout.
- Pre-sterilised option: standard filling assemblies can be supplied gamma sterilised and ready for use.
- Custom engineering: the complete assembly can be configured around dosage volume, process fluid and filling equipment.
Configuration and quotation
Filling assemblies should be configured around the filling machine, required dosage range and number of filling channels rather than the bag volume alone.
For technical configuration and quotation, provide the following information where available:
- Filling machine manufacturer and model
- Required filling-bag volume
- Product or process fluid
- Minimum filling volume
- Maximum filling volume
- Target filling accuracy
- Number of filling needles
- Required filling-needle diameter
- Needle connection type
- Pump type and pump-head configuration
- Pump tubing dimensions
- Required tubing lengths
- Inlet process connection
- Vent-filter requirement
- Upstream sterile-filtration requirement
- Required hanging-hole or bag-support geometry
- Sterilisation requirement
- Required conformity and validation documentation
- Prototype or qualification quantity
- Estimated annual demand
- Existing filling-system drawing or process sketch where available
If the final fluid path has not yet been defined, filling-machine model, dosage range, number of filling heads and process-fluid information provide a suitable starting point for technical configuration.