FiltraLinX® Automatic TFF System

The automatic TFF system adopts a modular design. It is equipped with filter holders of different specifications. According to process requirements, the system can be equipped with a rotor pump or a diaphragm pump.

The system is designed to be compact and practical. With batch management, the system can run the manufacturing recipe automatically with one click, thereby realizing the automatic operations of concentration, diafiltration, desalting, and dealcoholizing of biological products such as antibodies, vaccines, blood products, and gene therapy drugs.

The system is highly automatic and complies with the GMP regulations both in China and abroad, making it an ideal choice for the large-scale GMP-compliant manufacturing of medical products. The system is optimally designed for the manufacturing

of products requiring FDA approval, EU GMP certification, and WHO pre-qualification, as well as those under the stringent regulatory requirements in China, such as vaccines, blood products, and ADC drugs.

• Tailored to meet customer needs, ensuring 100% compliance with the URS.

• Adaptable system size based on the customer's process needs, layout, and utilities.

• System components from the industry's leading brands with hygienic designs and cleaning residues less than 3D.

• Works with various cassette areas, including spaces over 200 m2.

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

• PLC, weighing unit, pneumatic valve, circulation pump, feeding pump, flow meter, pressure gauge, pH, conductivity, UV, etc., supporting feedback control of TMP and Delta P, and capable of automatic process steps, such as concentration, equal- volume diafiltration, over-concentration, and CIP.

• 316L stainless steel product tank, sight glass, spray wash ball, magnetic agitator, sampling valve, insulating jacket, etc. The refrigerant flow can be finely adjusted, allowing precise temperature control of product. Additionally, the system is compatible with single-use mixing and storage bags for sample loading and collection.

• Online detection units to monitor flow rate, pressure, temperature, conductivity, pH, and UV in real time and summarize the process parameters into trend charts with reports in PDF format.

• Two panel solutions: Siemens 19-in IPC or Dell computer and industrial touchscreen monitor, with a large-capacity built-in solid-state drive to ensure smooth operation and data security.

• UPS ensures data recording and process recipe maintenance under power outage conditions.

• Online cassette integrity testing module, for automatic integrity testing of multiple cassettes and electronic batch reports, without the need for an external integrity detector.

• Emergency stop button and audible/visual tri-color alarm.

• Optional function of SIP.

• Automatically run CIP, SIP, water flux measurement, and cassette integrity testing, and independently generate electronic batch reports.

• The PLC is the Siemens S7-1500 series, capable of automatic operation with one click and feedback control throughout the process; pop-up prompts can also be set at any step for manual intervention.

• Customers can independently edit phases based on the minimum operating steps, and independently build the phase into a manufacturing process recipe based on different process steps.

• The system can save up to 50 manufacturing process recipes, applicable for scenarios such as CDMO, shared production line, process optimization, editable manufacturing steps, and flexible process recipe selection.

• The manufacturing process recipe can be exported, saved, restored, or copied to other BioLink automatic TFF systems for production call.

• Software operation interface in Chinese/English, loaded with Chinese input methods, and fully compliant with data integrity and electronic recording requirements.

• Batch management.

• Hierarchical alarm.

• Four-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.

• Upload system data to third-party SCADA platforms.

• System control can be integrated by third-party DCS platforms such as Delta V, PCS7, Plant Pax, etc.

• Bilingual Interface: Operation interface in Chinese and English, with Chinese input methods, meeting all requirements for data integrity and electronic records.

• Dual-Mode Operation: Supports one-click automatic operation with comprehensive feedback control. Manual intervention is possible at any step through customizable pop-up prompts.

• Recipe Editing: Allows customers to independently create process phases from minimal steps and compile these into recipes. The system can store up to 50 recipes, ideal for CDMO, shared lines, process optimization, and flexible recipe selection. Recipes can be exported, saved, restored, or transferred to other BioLink automatic ultrafiltration systems for production.

• Query: Provides access to parameter trends, event and alarm logs, and electronic batch reports, including separate reports for CIP, SIP, water flux, and filter integrity.

• Regulatory Compliance: Electronic batch reporting, multi-level access control, data integrity, audit trails, alarm management, synchronized clocks, and support for electronic records and signatures.

• Flexible Integration: Enables system data integration with third-party SCADA platforms and control integration with DCS platforms such as Delta V, PCS7, and Plant Pax.

• Bilingual Interface:

  Operation interface in Chinese and English, with Chinese input methods, meeting all requirements for data integrity and electronic records.

• Dual-Mode Operation:

  Supports one-click automatic operation with comprehensive feedback control. Manual intervention is possible at any step through customizable pop-up prompts.

• Recipe Editing:

  Allows customers to independently create process phases from minimal steps and compile these into recipes. The system can store up to 50 recipes, ideal for CDMO, shared lines, process optimization, and flexible recipe selection. Recipes can be exported, saved, restored, or transferred to other BioLink automatic ultrafiltration systems for roduction. 

• Query:

  Provides access to parameter trends, event and alarm logs, and electronic batch reports, including separate reports for CIP, SIP, water flux, and filter integrity. 

• Regulatory Compliance:

  Electronic batch reporting, multi-level access control, data integrity, audit trails, alarm management, synchronized clocks, and support for electronic records and signatures. 

• Flexible Integration:

  Enables system data integration with third-party SCADA platforms and control integration with DCS  platforms such as Delta V, PCS7, and Plant Pax.

For more information please visit Bio-Link website.