Hanbon Bio-TFF 180–30000 Automated Tangential Flow Filtration (TFF) System

Overview

The Hanbon Bio-TFF 180–30000 is an automated, programmable tangential flow filtration (TFF) system engineered for precision ultrafiltration (UF) and diafiltration (DF) in biopharmaceutical process development, pilot-scale manufacturing, and small-batch GMP production. Based on the fundamental principle of cross-flow membrane separation—where feed stream flows parallel to the membrane surface to minimize fouling—the system enables controlled concentration, buffer exchange, desalting, and purification of sensitive biologics including monoclonal antibodies (mAbs), recombinant proteins, viral vectors, vaccines, plasma-derived therapeutics, and nucleic acid-based products. Its modular architecture supports scalable operation from lab-scale optimization (as low as 180 mL minimum hold-up volume) up to 30 L/min permeate flux capacity, with integrated transmembrane pressure (TMP) regulation, real-time parameter monitoring, and full audit-trail compliance per FDA 21 CFR Part 11 and GAMP 5 standards.

Key Features

• Hygienic, ASME BPE-compliant construction using electropolished 316L stainless steel with tri-clamp and aseptic diaphragm valve interfaces
• Quattroflow™ quad-diaphragm pump delivering low-shear, low-pulsation flow—critical for shear-sensitive biomolecules such as VLPs and exosomes
• Automated TMP control algorithm maintaining consistent driving force across variable viscosity and concentration profiles
• Modular intermediate recirculation tank options (10–500 L), decoupled from the core filtration module to preserve minimal system hold-up volume
• Four-tier user access control (Operator, Technician, Engineer, Administrator) with role-based permissions and electronic signature capability
• Configurable method editor supporting fully automated CIP, concentration, isovolumetric DF, fraction collection, and end-of-run flush sequences
• Real-time monitoring of pressure differentials (feed, retentate, permeate), flow rates, temperature, conductivity, and bubble detection with four-level alarm hierarchy

Sample Compatibility & Compliance

The Bio-TFF 180–30000 accommodates both flat-sheet cassettes (e.g., GE Spectrum™, Sartorius Sartocon® Slice, Pall Acrodisc™ TFF) and hollow-fiber modules (e.g., Repligen KrosFlo®, Spectrum Labs Hollow Fiber Cartridges). Its sanitary fluid path design ensures complete drainability and cleanability—validated for ≤1-log residual carryover during cleaning verification studies. The system conforms to ISO 13485:2016 quality management requirements for medical device manufacturers and supports IQ/OQ/PQ documentation packages aligned with EU Annex 15 and USP Analytical Instrument Qualification. All firmware and software components are developed under GAMP 5 lifecycle management principles, with embedded change control, versioning, and electronic record integrity safeguards compliant with FDA 21 CFR Part 11 Subpart B.

Software & Data Management

The embedded HMI runs on a validated Windows IoT platform with proprietary TFF Control Suite v4.x. It provides intuitive graphical workflow navigation, multi-mode operation (debug, manual, semi-automated, fully automated), and context-sensitive help. All process parameters—including time-stamped sensor data, method execution logs, operator actions, and alarm events—are stored locally in encrypted SQLite databases with optional OPC UA or Modbus TCP export for integration into MES/SCADA environments. Audit trails include immutable timestamps, user IDs, and before/after values for any parameter modification. Data exports support CSV, PDF, and XML formats, and are structured to meet GLP/GMP data integrity expectations (ALCOA+ criteria).

Applications

• Blood Products: Ethanol removal and concentration of albumin and immunoglobulins; heavy metal ion clearance via chelating UF membranes
• Vaccines: Clarification of cell culture harvests; concentration and buffer exchange of virus-like particles (VLPs) and live-attenuated viruses; endotoxin reduction in final formulation buffers
• Gene Therapy & mRNA: Purification and formulation of lipid nanoparticles (LNPs); removal of unencapsulated nucleic acids and residual solvents
• Antibiotics & Enzymes: Mycelial broth clarification; removal of pyrogens and high-MW impurities from fermentation broths
• Traditional Chinese Medicine (TCM): Depyrogenation and polysaccharide fractionation in injectable herbal preparations
• WFI Systems: Final polishing of water-for-injection streams using ultra-low-endotoxin UF membranes (e.g., 10 kDa MWCO)

FAQ

What membrane formats are supported by the Bio-TFF 180–30000?
The system accepts standard industry cassettes (GE, Sartorius, Pall, Meissner) and hollow-fiber cartridges (Repligen, Spectrum Labs, Microdyn-Nadir) via interchangeable manifold kits.
Does the system support regulatory submissions for clinical manufacturing?
Yes—full validation documentation (URS, FRS, DQ/IQ/OQ/PQ protocols and reports), traceable calibration records, and 21 CFR Part 11-compliant software logs are provided as part of the GMP package.
Can the system be integrated into existing automation infrastructure?
It supports OPC UA server functionality, Modbus TCP, and analog I/O expansion modules for seamless connection to DeltaV, PCS7, or other DCS/PLC platforms.
Is remote monitoring or troubleshooting available?
Optional secure VPN-enabled remote diagnostics is available under service agreement, with TLS 1.2 encryption and session logging.
What is the typical lead time for custom configuration and qualification?
Standard configurations ship within 12 weeks; IQ/OQ execution adds 4–6 weeks depending on site readiness and protocol scope.