Single-Use TFF System

TFF System for Bioprocessing

Precision flow, gentle processing. TFF concentration, buffer exchange and formulation with ultra-low shear pumping, 30 mL to 10 L.

Our single-use TFF system supports bioprocess development and clinical manufacturing. Standard TFF processing of AAV and lentiviral vectors loses 20–40% of product titer to pump-induced shear damage. This TFF system replaces peristaltic pumps with a single-use diaphragm pump. The result is 4.4× better product filterability. Pair it with our custom single-use bags and flow path assemblies for a complete TFF fluid path.

Single-use TFF system, 350 mL configuration
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Working Volume30 mL – 10 L
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Max Pressure6 bar
Max Flow Rate5.1 L/min
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Filterability4.4× vs Benchmark
The Advantage

Why This TFF System

Conventional peristaltic-pump TFF skids lose 20–40% of product titer to pump-induced shear. This single-use TFF system replaces the peristaltic pump with a low-shear diaphragm pump, protecting sensitive biologics through every TFF cycle.

Ultra-Low Shear TFF

The diaphragm pump moves product through the TFF loop without compression or tubing wear, protecting viral vectors, cells and fragile proteins.

Stable TFF Pressure Profiles

Very low pulsation keeps transmembrane pressure consistent across the run — no spikes, no fouling surprises, better flux and yield.

Seamless TFF Scale-Up

One TFF system architecture from 30 mL screening to 10 L clinical batches. Same flow behaviour at every scale, no process redesign.

Fully Single-Use TFF Flowpath

Modular pre-assembled flow path sub-kits. No cleaning validation between runs — swap kits in minutes.

Closed-Loop TFF Control

Eight sensors, two control valves and thirteen process valves maintain constant TMP, constant flux and automated diafiltration out of the box.

GMP-Compatible TFF Design

FDA-compliant wetted materials, USP Class VI, gamma-validated. Start developing on this TFF system today, validate when you're ready.

30 mL–10 LTFF Working Volume
6 barMax Operating Pressure
5.1 L/minMax Feed Flow Rate
4.4×Better Filterability

TFF Applications

This TFF system handles concentration, diafiltration and combined workflows across ultrafiltration-grade membranes — from pre-clinical through clinical manufacturing.

Monoclonal Antibodies (mAb, Fab, scFv)Viral Vectors (AAV, Lentivirus)Vaccines & VLPsCell Therapy ProductsEnzymes & Recombinant ProteinsExosomes & LNPsGene TherapyADC Intermediates
Choose Your Scale

TFF System Configurations

Three vessel sizes, one TFF architecture. Choose the configuration that matches your process volume — the same pumps, control logic and flow path design carry across every scale.

TFF-350mL rigid vessel configuration

TFF-350mL

30 – 350 mL
VesselRigid vessel
Connection3/4" TC
Line Size1/8"
Feed PumpP0 Fast Prime
Max Flow0.73 L/min
Best ForScreening, early PD
TFF-2L configuration with 2.5D single-use bag vessel

TFF-2L

100 – 2,000 mL
Vessel2.5D bag
Connection1.5" TC
Line Size1/8" or 1/4"
Feed PumpP0 or P10
Max Flow1.10 – 5.1 L/min
Best ForProcess development
TFF-10L configuration with 2.5D single-use bag vessel

TFF-10L

500 – 10,000 mL
Vessel2.5D bag
Connection1.5" TC
Line Size1/8" or 1/4"
Feed PumpP0 or P10
Max Flow1.10 – 5.1 L/min
Best ForLate PD, clinical mfg

System hardware supports 0–6 bar across all TFF configurations. Actual operating pressure depends on membrane format — hollow fiber modules are typically limited to under 4 bar by the manufacturer, while cassette formats support the full pressure range.

Powered by a Low-Shear Diaphragm Pump

The single-use diaphragm pump at the heart of this TFF system moves feed through the loop with ultra-low shear and minimal pulsation. Three (P0) or five (P10) diaphragms in a vertical orientation are engineered specifically for sensitive biologics.

SpecificationP0 Fast PrimeP0P10
Flow Range0.73 – 730 mL/min0.73 mL – 1.10 L/min1.7 mL – 5.1 L/min
Displacement0.73 mL/rev0.73 mL/rev1.7 mL/rev
RPM Range1 – 1,0001 – 1,5001 – 3,000
Internal Volume14 mL22 mL45 mL
Outlet Size1/8"1/8"1/4"
Max Pressure6 bar6 bar6 bar

TFF Instrumentation & Automation

Every TFF parameter is measured and every flow path is controlled. Four pressure sensors, two flow sensors, conductivity measurement and two proportional control valves are fully integrated with the automation platform.

Sensors

TagTypePurpose
PT01PressureTransfer pump safety
PT10PressureFeed pressure (Pf)
PT20PressureRetentate pressure (Pr)
PT30PressurePermeate pressure (Pp)
FE20FlowCross/retentate flow (Fr)
FE30FlowPermeate flow (Fp)
AE30ConductivityDiafiltration endpoint (0.02–200 mS/cm)

Control Modes

ModeDescription
Constant TMPPrimary backpressure valve, secondary trim
Constant FluxPermeate bleed mode, auto TMP adjustment
Fed-BatchAutomated feed addition with volume tracking
DiafiltrationConductivity endpoint, buffer valve sequencing

TMP = (Feed Pressure + Retentate Pressure) ÷ 2 − Permeate Pressure

Single-Node Operation

  • Complete local TFF process control, no cloud dependency
  • On-device data storage and full audit trail
  • Recipe management and automatic batch records
  • 21 CFR Part 11-ready architecture
  • Touchscreen HMI, no internet connection required

Cloud-Connected TFF Fleets

  • Everything in single-node operation, plus:
  • Centralised cloud data lake across multiple TFF systems
  • Multi-system coordination and facility-wide event bus
  • Data-driven TFF process optimisation
  • Global access and remote monitoring

Single-Use TFF Flowpath

The TFF flowpath is divided into modular sub-kits that can be configured and purchased separately. Each kit is pre-assembled, gamma-compatible, and rated for a two-year shelf life.

1

Transfer Pump

Product and buffer transfer via five inlet valves, a Fast Prime pump, and two transfer valves.

2

Feed

Rigid vessel or 2.5D single-use bag, feed pump, feed pressure sensor and collection valve.

3

Permeate

Permeate pressure and conductivity sensors, flow sensor, control valve, and outlet valves for waste routing.

4

Retentate

Retentate pressure and flow sensors, TMP control valve, and valves for upper/lower return and waste.

This TFF system is brand agnostic and compatible with most cassette and hollow fiber membrane modules on the market via standard tri-clamp and luer connections. Build out the complete fluid path with custom flow path assemblies, pinch valves and diaphragm valves, or overmolded components for custom port geometries.

TFF System FAQ

What working volumes does this TFF system support?

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Three configurations cover the full development path. TFF-350mL (30–350 mL) suits early process development and screening. TFF-2L (100–2,000 mL) suits process development and pre-clinical work. TFF-10L (500–10,000 mL) suits late-stage development and clinical manufacturing.

What membranes are compatible with this TFF system?

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The system is brand agnostic. It works with most cassette and hollow fiber membrane modules on the market. Standard tri-clamp and luer connections let you integrate membranes from any major manufacturer, so you can choose the format and MWCO that suits your process.

Is this TFF system GMP compatible?

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Yes. It is process-development ready and GMP-compatible by design. All wetted components use FDA-compliant, USP Class VI, gamma-validated materials. The full system architecture, including hardware, single-use flowpath and automation, supports qualification to GMP standards at your discretion.

Can this TFF system run both cassettes and hollow fiber modules?

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Yes. It supports both cassette and hollow fiber formats through standard tri-clamp and luer connections. Hardware supports 0–6 bar across all configurations. Hollow fiber modules are usually limited to under 4 bar by the manufacturer. Cassette formats support the full pressure range.

What is the minimum working volume for this TFF system?

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30 mL, using the TFF-350mL configuration with a rigid vessel. This suits early screening work where material is scarce. It lets you run real TFF experiments at volumes that would be impractical on larger systems.

How does this TFF system control TMP?

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Transmembrane pressure is measured in real time using four pressure sensors: feed, retentate, permeate and transfer safety. TMP equals feed plus retentate, divided by two, minus permeate. Two proportional control valves hold your TMP setpoint automatically through closed-loop control.

Can I use this TFF system for process development and then scale up?

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Yes. That is the core design principle. The same pump architecture, valve control and automation carry across all three configurations. Process parameters transfer directly from 30 mL screening to 10 L clinical batches without redesign.

Does this TFF system require compressed air?

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No. The system uses electric-drive diaphragm pumps and electric diaphragm valves. It runs entirely on 24V DC with no compressed air infrastructure required. That is one less utility to qualify and one less facility dependency.

How long does it take to set up this TFF system between runs?

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As little as five to fifteen minutes for experienced personnel. The modular sub-kit design means you swap pre-assembled flow path sections instead of replumbing. No complex plumbing and no tools are required.

Ready to See This TFF System in Action?

Tell us about your process and we'll help you select the right TFF configuration, membrane format and sub-kit combination.