Pilot Scale Tangential Flow Filtration System

Pilot Scale Tangential Flow Filtration System

Compared to laboratory benchtop equipment, this pilot-scale system delivers significantly higher crossflow stability during continuous operation, superior pressure control over extended filtration cycles, and a highly representative simulation of industrial-scale fluid dynamics.

  • Product Introduction
 

Product Overview

 

The Jiuling Pilot-Scale TFF System bridges the gap between benchtop R&D and commercial manufacturing. It is an essential tool for bioprocess engineers when:

  • Laboratory optimization results require validation at increased process volumes.
  • Membrane performance and fouling behavior must be verified prior to full-scale production.
  • Filtration parameters require fine-tuning under real-world operating conditions.

Compared to laboratory benchtop equipment, this pilot-scale system delivers significantly higher crossflow stability during continuous operation, superior pressure control over extended filtration cycles, and a highly representative simulation of industrial-scale fluid dynamics.

 

 

Technical Specifications

 

Parameter

Specification

Working Volume

5–50 L (customizable)

Membrane Types

Flat sheet cassette / hollow fiber

Membrane Area

Configurable based on process scale

Filtration Modes

Concentration / Diafiltration / Buffer exchange

Crossflow Control

Pump-speed based adjustment

TMP Control Range

Defined operating pressure window

Operating Pressure

Low to moderate bioprocess range

Temperature Range

Process-dependent

Wetted Materials

316L stainless steel / biocompatible tubing

Control Mode

Manual / Semi-automatic

CIP/SIP Compatibility

Optional depending on configuration

Connections

TC / sanitary fittings / customized interfaces

 

 

System Advantages

 

Stable Process Control: The proprietary flow path design eliminates pressure fluctuations during long-duration runs, ensuring highly stable TMP behavior.
Seamless Scale-Up Consistency: System geometry directly mirrors industrial-scale TFF structures, ensuring a reliable, predictable transfer of R&D data to full commercial manufacturing.
Flexible Process Adaptation: Highly adaptable configuration tailored to product viscosity, fouling tendencies, shear sensitivity, and target molecule recovery requirements.
Enhanced Process Visibility: Real-time data monitoring and trend charting allow process engineers to detect deviations early, protecting high-value biological batches.

 

 

Application Areas

 

01/

Biopharmaceutical Processing
Monoclonal antibody (mAb) concentration and formulation after chromatography.
Downstream protein concentration and automated buffer exchange prior to final filling.

Vaccine intermediate concentration and purification (viral/bacterial antigens).

02/

Cell and Gene Therapy (CGT)
Viral vector (AAV, Lentivirus) concentration prior to purification.
Cell harvest clarification and perfusion washing.
Media exchange and conditioning during downstream transitions.

03/

Industrial Biotechnology
Industrial enzyme concentration and diafiltration.
Fermentation broth clarification and biomass separation.
Functional protein and peptide purification.

04/

Process Development & Validation
Membrane material and pore-size screening studies.
Critical Process Parameter (CPP) optimization (crossflow, TMP, flux).
Scale-up and scale-down validation modeling.

 

 

Typical Operating Workflow

 

System Assembly: Install selected membrane modules and connect auxiliary lines.
Flushing & Integrity Testing: Flush the system with buffer/WFI and perform membrane integrity/leak checks.
Feed Loading: Load the biological crude product into the feed reservoir.
Initialization: Start the low-shear pump and establish steady-state crossflow and TMP stabilization.
Processing: Execute automated Concentration or Diafiltration (buffer exchange) operation.
Harvesting: Maximize product recovery via optimized low-dead-volume retentate collection.
CIP & Storage: Perform Clean-in-Place cycles and prepare the system/membrane for the next batch.

 

 

System Configuration

Each system is configured based on process requirements and membrane selection.

Flow Loop Design

Feed tank with controlled recirculation loop
Adjustable peristaltic or diaphragm pump
Retentate and permeate flow paths designed for stable circulation

Filtration Module

Compatible with flat sheet cassette and hollow fiber membranes
Modular membrane housing for different surface areas
Quick-change structure for process screening and optimization

Instrumentation

Feed, retentate, and permeate pressure sensors
Real-time TMP calculation
Flow monitoring for process stability control

Operation Mode

Manual or semi-automatic control
Adjustable flow rate and pressure settings during operation
Optional data logging for process tracking

 

 

Quality Assurance

 

Every Jiuling TFF system undergoes rigorous pre-shipment testing to guarantee out-of-the-box reliability:

  • Hydrostatic pressure testing and full flow-path leak-free integrity certification.
  • Dynamic pump performance and sensor calibration validation.
  • Complete component traceabilty and material certificates (MTRs for 316L, USP Class VI for polymers).
  • Comprehensive operational readiness verification to ensure immediate integration into standard bioprocess workflows.

 

 

FAQ

 

Q: What is the function of a pilot-scale TFF system?

A: It is used to validate laboratory process conditions under realistic operating volumes before production scale-up.

Q: How does pilot scale improve scale-up reliability?

A: It allows verification of TMP, flux behavior, and crossflow conditions before full-scale manufacturing.

Q: What are the key parameters in TFF scale-up?

A: Crossflow velocity, TMP operating window, and flux (LMH) are the main control parameters.

Q: Can the system be used in GMP environments?

A: Yes, depending on configuration and material selection.

Q: What membrane types are supported?

A: Flat sheet cassette and hollow fiber membrane formats are supported.

Q: Can operating conditions be adjusted during processing?

A: Yes, flow rate and pressure can be adjusted in real time.

Q: Is the system suitable for sensitive biological products?

A: Yes, all wetted materials are selected for bioprocess compatibility.

Q: Can the system be customized?

A: Yes, system configuration, membrane area, and control options can be customized.

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