GMP Grade Tangential Flow Filtration System
It operates in crossflow mode, where the feed flows tangentially across the membrane surface. This reduces fouling and supports stable filtration performance during continuous processing.
- Product Introduction
System Overview
The GMP Grade TFF system is used for ultrafiltration (UF) and diafiltration (DF) in downstream bioprocessing.
It operates in crossflow mode, where the feed flows tangentially across the membrane surface. This reduces fouling and supports stable filtration performance during continuous processing.
The system is typically installed between chromatography purification and final formulation steps.
Typical Configuration Parameters
|
Item |
Specification |
|
Filtration Area |
0.1 m² – 20 m²+ |
|
Operating Pressure |
Up to 6 bar (configurable) |
|
Temperature Range |
4–40°C |
|
Membrane Types |
Hollow fiber / Cassette / Spiral wound |
|
Flow Mode |
Recirculation or single-pass (optional) |
|
Control System |
PLC-based (Siemens or equivalent options available) |
Core Advantages
Seamless Scale-Up: Engineered to bridge the gap between R&D scale validation and full GMP commercialization.
Universal Membrane Compatibility: Open-architecture hardware accepts cassettes and hollow fibers from major global membrane manufacturers.
Global Components Standard: Built with globally serviceable components for easy local maintenance.
Minimized Yield Loss: Optimized low-volume piping configuration ensures excellent yield recovery even during high-viscosity or high-concentration operations.
Process Applications in Biomanufacturing
The system is widely applied in the following critical downstream processing (DSP) steps:
Monoclonal Antibodies (mAbs): Post-Protein A concentration and formulation.
Viral Vectors & Vaccines: Concentration and buffer exchange prior to polishing chromatography.
Cell Harvesting: Clarification and primary concentration before capture chromatography.
Final Formulation: High-concentration buffer exchange (UF/DF) prior to sterile filling.
Recombinant Proteins & Enzymes: Concentration and purification of sensitive biomolecules.
Key System Features
GMP-Compliant & Hygienic Engineering
Premium Materials: All product-contact parts are fabricated from SS316L with complete EN 10204 3.1 material traceability.
Hygienic Piping: Engineered according to ASME BPE standards, featuring minimized dead zones and optimized low hold-up volume to maximize product recovery.
Surface Finish: Internal product-contact surfaces are electropolished to Ra ≤ 0.4 μm as standard.
Sanitary Integration: Fully compatible with automated Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP) protocols to guarantee cleaning reproducibility.
Advanced Process Control & Stable Flux
Automated Balance: High-precision flow meters and control valves manage the feed, retentate, and permeate flow balance.
Real-Time TMP Monitoring: Multi-point pressure sensors dynamically feedback to control loops, preventing over-pressurization and membrane damage.
Shear Optimization: Adjustable, low-shear feed pumps protect shear-sensitive proteins or viral vectors while maintaining optimum crossflow velocity.
Scalable Process Transfer
The flow path geometry and control logic are standardized across all system sizes. Key parameters validated at the lab scale-such as crossflow velocity, TMP, and flux capacity-can be directly transferred to pilot and production scale without altering the core process logic.
Automation & Data Integrity
User-Friendly Interface: Intuitive PLC + HMI interface supporting recipe-based batch operations.
Comprehensive Monitoring: Continuous real-time data logging for pressure, flow, temperature, and conductivity.
Data Traceability: Configurable to meet FDA 21 CFR Part 11 and GAMP 5 guidelines, incorporating multi-level user access control, electronic signatures, and unmodifiable audit trails.
Modular Skid Design
Compact Footprint: Open, frame-mounted stainless steel skid design allows for easy maintenance access and efficient footprint utilization.
Plug-and-Play Integration: Uses standard sanitary Tri-clamp connections for rapid onboarding into existing upstream or downstream lines, minimizing on-site piping installation.
Documentation & Validation Support
To support regulatory filings (FDA, EMA, NMPA), we provide a comprehensive validation documentation package:
- Factory Acceptance Test (FAT) Protocol & Report
- Material Certificates (EN 10204 3.1) and USP Class VI compliance for gaskets/O-rings
- Instrument Calibration Reports (traceable to international standards)
- Weld Inspection Log (including borescope videos and welding gas logs)
- Installation Qualification (IQ) and Operational Qualification (OQ) Support Documents
Export Packaging & Global Delivery
Every TFF system undergoes multi-layer industrial protection prior to international transit:
Structural Integrity: Heavy-duty, steel-reinforced ocean/air-worthy wooden crates.
Instrument Protection: Internal shock-absorbing cushioning for delicate sensors, valves, and glass components.
Environmental Shielding: Moisture-proof, vacuum-sealed barrier packaging for the electrical control cabinets and automated components.
Pre-shipment Verification: Complete mechanical, electrical, and wet-testing functional checks before sealing.
After-Sales Services
Remote engineering installation and piping alignment guidance.
On-site commissioning, Site Acceptance Test (SAT) execution support, and operator training.
Customized spare parts planning (critical gaskets, sensors, and wear parts).
Lifecycle technical troubleshooting and software/automation modification assistance.
FAQ
Q: What batch volumes can your TFF systems process?
A: Our range covers everything from 1 L laboratory-scale development systems up to 2,000+ L commercial GMP production skids.
Q: Is the control system fully compliant with international GMP and data regulations?
A: Yes. Our automation architecture can be configured to comply fully with FDA 21 CFR Part 11 and GAMP 5, providing secure audit trails, user access levels, and secure data logging.
Q: Do you support custom skid layouts or component brands?
A: Absolutely. We offer flexible engineering customization. We can design the skid footprint to fit your room constraints and utilize your site-preferred brands for pumps, valves, and instrumentation (e.g., Watson-Marlow, Burkert, E+H).
Q: What validation documentation is included?
A: We provide a comprehensive turn-over package (TOP) including FAT, IQ/OQ protocols, welding maps, borescope logs, and EN 10204 3.1 material certificates to support your validation process.
Q: What is the typical lead time for an export-grade system?
A: Depending on the system's scale and automation complexity, typical lead times range from 6 to 12 weeks from design approval to FAT.
Q: Are your systems compatible with CIP and SIP?
A: Yes. The entire system features automated CIP capability. SIP configurations are available as an option for systems utilizing stainless steel housings or specific steam-sterilizable cassettes/hollow fibers.
Inquiry Information Required
To prepare a system proposal, please provide:
- Process step (UF concentration / DF / buffer exchange)
- Target batch volume
- Membrane type preference
- Integration requirements
We will provide a configuration recommendation based on your process needs.
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