TFFi™ — Single-Use TFF System
TFFi™ is Alphinity's single-use Tangential Flow Filtration (TFF) system for bioprocess development and clinical manufacturing. Concentration, buffer exchange, and formulation — with ultra-low shear pumping. 30 mL to 10 L.
Why TFFi™
Standard AAV and lentiviral vector TFF processing loses 20–40% of product titer due to pump-induced damage. TFFi™ replaces peristaltic pumps with the PIXER® single-use diaphragm pump — delivering 4.4× better product filterability versus low-shear benchmark pumps.
PIXER® diaphragm pumps move product without compression or tubing wear. Protects viral vectors, cells, and fragile proteins.
Very low pulsation means consistent transmembrane pressure. No spikes, no fouling surprises. Better flux, better yield.
One architecture from 30 mL screening to 10 L clinical batches. Same flow behaviour at every scale — no process redesign.
Modular pre-assembled flowpaths. No cleaning validation. Swap sub-kits between runs in minutes.
8 sensors, 2 control valves, 13 process valves. Constant TMP, constant flux, and automated diafiltration out of the box.
FDA-compliant wetted materials, USP Class VI, gamma-validated. Start developing today — validate when you're ready.
Applications
TFFi™ handles ultrafiltration, diafiltration, and combined UF/DF workflows for pre-clinical through clinical manufacturing.
System Configurations
Choose the vessel that matches your process volume. TFFi™ handles the rest — same pumps, same control, same flowpath logic at every scale.
30 – 350 mL
100 – 2,000 mL
500 – 10,000 mL
Pressure note: System hardware supports 0–6 bar across all configurations. Actual process operating pressure depends on membrane format — hollow fiber modules are typically limited to <4 bar by the manufacturer. Cassette formats support the full pressure range.
Pump Technology
The PIXER® single-use diaphragm pump is the heart of every TFFi™ system. Five diaphragms, vertical orientation, ultra-low shear — engineered specifically for sensitive biologics.
| Specification | P0 Fast Prime | P0 | P10 |
|---|---|---|---|
| Flow range | 0.73 mL – 730 mL/min | 0.73 mL – 1.10 L/min | 1.7 mL – 5.1 L/min |
| Displacement | 0.73 mL/rev | 0.73 mL/rev | 1.7 mL/rev |
| RPM range | 1 – 1,000 | 1 – 1,500 | 1 – 3,000 |
| Internal volume | 14 mL | 22 mL | 45 mL |
| Outlet sizes | 1/8" | 1/8", 1/4" | 1/4" |
| Max pressure | 6 bar | 6 bar | 6 bar |
Instrumentation & Control
TFFi™ provides complete process visibility with 4 pressure sensors, 2 flow sensors, conductivity measurement, and 2 proportional control valves — all integrated with ConSynSys™ automation.
| Tag | Type | Purpose |
|---|---|---|
| PT01 | Pressure | Transfer pump safety |
| PT10 | Pressure | Feed pressure (Pf) |
| PT20 | Pressure | Retentate pressure (Pr) |
| PT30 | Pressure | Permeate pressure (Pp) |
| FE20 | Flow | Cross/retentate flow (Fr) |
| FE30 | Flow | Permeate flow (Fp) |
| AE30 | Conductivity | DF endpoint (0.02–200 mS/cm) |
| Mode | Description |
|---|---|
| Constant TMP | CV20 primary backpressure, CV30 trim |
| Constant flux | CV30 bleed mode, auto TMP adjustment |
| Fed-batch | Automated feed addition with volume tracking |
| Diafiltration | AE30 endpoint, buffer valve sequencing |
TMP = (Pf + Pr) / 2 − Pp
All pressures measured in real time. Closed-loop control maintains your setpoint automatically.
Membrane Compatibility
TFFi™ is compatible with most cassette and hollow fiber membrane modules on the market. Standard tri-clamp and luer connections allow integration with membranes from all major manufacturers — choose the format and MWCO that suits your process.
Process Development Ready. GMP-compatible by design. All wetted components use FDA-compliant, USP Class VI, gamma-validated materials. The complete system architecture — hardware, single-use flowpath, and automation — is built to support qualification to GMP standards at the customer's discretion. Start developing today. Validate when you're ready.
Automation
TFFi™ ships with ConSynSys™ ProCaaSo® — a cloud-native process control platform built for biopharma. Every system launches as a single local node with full standalone capability. When you're ready to scale, connect to the cloud and unlock facility-wide orchestration.
Real-time TMP control, constant flux operation, automated diafiltration — all running locally with sub-second response times. No cloud dependency for critical control.
Every sensor reading, valve action, and operator interaction captured with full context. ALCOA+ compliant by architecture — attributable, legible, contemporaneous, original, accurate.
Single port, single protocol. Role-based access control with electronic signatures. Your process data stays yours — encrypted at rest and in transit.
Store, recall, and version your process parameters. ISA-88 batch control structure with automatic batch record generation for every run.
Configurable pressure limits, flow deviation alerts, and process excursion interlocks. Safety-first design with full alarm history logging.
Real-time trending, batch comparison, and process parameter analysis. Contextualized data ready for AI-powered optimization when you connect to the cloud.
Full standalone operation — everything you need, right on the system.
Unlock enterprise capabilities when you're ready to scale.
Start local. Scale global. Every TFFi™ system ships as a fully capable single node. No cloud subscription required. When your operation grows — connect to the ConSynSys™ cloud and turn individual systems into a coordinated manufacturing network. Powered by ProCaaSo® from ConSynSys™ Technologies.
Single-Use Flowpath
The TFFi™ flowpath is divided into modular sub-kits that can be configured and purchased separately. Pre-assembled, gamma-compatible, 2-year shelf life.
Product and buffer transfer via 5 inlet valves (XV01–05), P0 Fast Prime pump, and 2 transfer valves (XV06–07).
Vessel (rigid or 2.5D bag) with feed pump (P0 FP, P0, or P10), PT10 pressure sensor, and XV11 collection valve.
PT30, AE30 conductivity, FE30 flow sensor, CV30 control valve, and XV31/32 outlet valves for waste routing.
PT20, FE20 flow sensor, CV20 TMP control valve, and XV21/22/23 for upper/lower return and waste.
Get Started
Talk to our team about your application. We'll help you select the right configuration, membrane format, and sub-kit combination for your process.