BioHub®Fill Single-use Bulk Filling System is a flexible automated filling platform which allows sequential dispensing of large volumes of bulk product into single-use bags or bottles. The system enables various sterile connection and disconnection methods to improve overall production efficiency while reducing batch and inter-batch errors.
With an increasing market demand for vaccines, antibodies and other drug products, the production system of biopharmaceutical manufacturers is gradually expanding. Reaction systems with capacities exceeding 10,000 L are now in operation, creating a downstream demand to collect, freeze over 1,000 L of bulk solution. Optimizing the management of the bulk solution filling process during production has become a major challenge for biopharmaceutical companies.
Conventional manual dispensing methods remain widely used, but they are often inefficiency and carry a high risk of contamination. As the regulatory system of pharmaceutical manufacturing continues to improve, the importance of effective fluid management has come into sharper focus. In response to the market demand, BioLink has developed BioHub®Fill Single-use Bulk Filling system. This automated solution enables accurate and efficient filling. While reducing overall production costs, it improves production efficiency and meets data recording compliance requirements.
Take the 500 L production line of an antibody customer with the bulk product of about 80 L as an example:
| Item | Automated Filling | Manual Filling |
| Personnel/Time | 2 operators/1 h | 3 operators/3 h |
| Labor Operating Cost (CNY/lot) | 600 | 2700 |
| Consumables Cost (CNY/lot) | A | A |
| Fixed Cost (W) | 80 (for reference only) | 10 (for reference only) |
| Filling Accuracy | ≤ ±0.6% | Uncontrollable |
| Contamination Risk | Very low | Moderate |
| Scalability | Support scaling | Additional staffing is required if production increases |
| Compliance | Password complexity Three-level permissions Data recording Audit trail | Complexity of manual recording Trivialness of SOP handwriting Mobility of personnel |
| Automated Manual Filling | Dual modes: |
| • Manual mode for determining key parameters by admin before filling | |
| • Automated mode for fully automated filling during user's production | |
| High Accuracy | PID adjustment enables precise linkage between the weighing signal and the peristaltic pump signal, achieving filling accuracy as low as ≤ ±0.6% |
| High Flexibility and Compatibility | Customizable dispensing brackets for freeze-thaw boxes & bottles of different brands and specifications |
| Bubble-free and Low Residual | Unique hardware structure with highly sensitive sensors for bubble-free filling and low residual recovery |
| Manifold Leak Test | Set process parameters based on tubing specifications for automated integrity testing |
| Real-Time Pressure Monitoring | Peristaltic pumps and pressure values are linked to greatly reduce the risk in filling |
| Data Traceability & Integrity | Real-time data recording, audit trails, data alarms, and electronic signatures meet the requirements of FDA 21 CFR Part 11; Interfaces available for interaction with other systems |
For high-precision sterile filling, matching consumables are essential. BioLink offers customizable filling consumables based on the bracket sizes, software logic design and usage requirements. For non-critical components, alternatives can be provided, such as pressure sensors for whole process monitoring rather than control. Other critical components such as manifold, sterile filters and connectors can be customized as required.


| Item | Automated Filling |
| Components | ① Control cabinet |
| ② Dispensing bracket | |
| ③ Pump | |
| Equipment Dimensions | Control cabinet (mm): 1052*689*1567 |
| Dispensing bracket: Customizable | |
| Equipment Weight | Control cabinet (kg): 110 |
| Dispensing bracket: Customizable | |
| Compatibility | Compitable with freeze-thaw boxes and bottles of different brands and specifications |
| Dispensing Bag/Bottle Limits | 18 |
| Supported Freeze-thaw Box/Bottle Sizes | 5L/10L/20L/50L (bags) |
| 5L/10L/20L (bottles) | |
| Filling Accuracy | ≤ ±0.6% (PID adjustment of pump) |
| Disconnection Method | Manual sealer/Electric cutter |
| Valve | Electric valve/Pinch valve |
| Pump | Diaphragm pump/Peristaltic pump |
| Weighing Mode | Overall 4-point weighing |
| Label Printer | Support freezing at -80°C, customizable printed information |
| Barcode Scanner | Standard configuration |
| Display | Advantech IPC/Siemens IPC |
| Slave Device | Siemens S7-1200 series |
| Power Supply/Power | 220V/2000W |
*For any other automated filling requirements, please contact BioLink technical team for customization.
**Please be advised that this product is only available for sale and after-sales support in certain regions. For further details, kindly consult with your local sales representative. Thank you for your understanding.
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