FiltraLinX® Semi-automatic TFF System

The semi-automatic TFF system adopts a modular design and is available in benchtop and floor-standing models. It is equipped with filter holders of different specifications. According to process requirements, the circulation pump can be flexibly configured with a rotor pump or a diaphragm pump.

The system is designed to be compact and practical. With automatic feedback and adjustment of the flow rate and pressure, the automatic control of TMP and Delta P is available, thereby realizing the automatic operations of concentration, diafiltration, desalting, and dealcoholizing of biological products such as antibodies, vaccines, blood products, and gene therapy drugs.

Due to its automatic operation, cost-effectiveness, and compliance with regulations related to data integrity, the system is an ideal choice for filtration systems in pilot-scale manufacturing, medical product manufacturing for clinical use, and the GMP manufacturing phase for some products, especially for polyvalent pneumococcal vaccines, blood products, gene therapy medicines, and cell therapy drugs.

• Available in various specifications: Standard benchtop model for 0.1–0.5 m2 cassettes; standard benchtop model for 0.5–2.5 m2 cassettes; floor-standing models for different cassette sizes, even 200 m2 and above.

• PLC, weighing unit, manual valve, circulation pump, flow meter, pressure sensor, supporting feedback control of TMP and Delta P, to facilitate automatic manufacturing.

• Compatible with both the ultrafiltration cassettes and hollow fiber filters.

• Filtration tank (available in PP and 316L stainless steel) with window, compatible with single-use mixing and storage bags for sample loading and collection.

• Feeding pump for equal-volume diafiltration.

• Siemens 12-in HMI panel.

• Software operation interface in Chinese/English, loaded with Chinese input methods.

• Emergency stop button.

• Hierarchical alarm.

• Three-tier access control.

• Comply with the requirements on electronic record and electronic signature management in FDA 21 CFR Part 11.

• Comply with audit trail requirements.

• Display of process parameter trend charts with reports in PDF format.

• Reserved cassette integrity detection interface.

• Reserved SCADA system data interface.

• Optional instruments: online pH, online conductivity, and online UV.

• Optional functions: CIP and water flux detection.

For more information please visit Bio-Link website.