Cytiva ÄKTA flux 6 Tangential Flow Filtration System

Overview

The Cytiva ÄKTA flux 6 Tangential Flow Filtration (TFF) System is an engineered semi-automated platform designed for precise, scalable, and reproducible biomolecule processing in upstream and downstream bioprocessing workflows. Based on the fundamental principle of tangential flow—where feed solution flows parallel to the membrane surface to minimize fouling and maintain consistent flux—the system enables controlled concentration, buffer exchange (diafiltration), clarification of cell lysates or fermentation broths, and gentle harvesting of mammalian or microbial cells. Its architecture integrates fluidic precision, real-time pressure and flow monitoring, and intuitive process logic to support both bench-scale development and early-stage process optimization. As a complementary unit to Cytiva’s ÄKTA chromatography platforms, the ÄKTA flux 6 bridges purification workflow gaps by delivering robust, low-shear filtration performance without requiring full automation infrastructure.

Key Features

• Semi-automated operation with programmable process steps—including constant retentate volume (CRV), constant transmembrane pressure (TMP), or constant permeate flow modes—enabling operator-independent execution of repeatable protocols.
• Low minimum working volume capability (down to 50 mL) supports high-concentration factors (>50×) while preserving sample integrity and minimizing hold-up volume losses.
• Modular fluid path design accommodates both hollow-fiber modules (e.g., Xampler, KrosFlo series) and flat-sheet cassette membranes (e.g., Pellicon, Viresolve), with standardized fittings and pressure-rated connections up to 4 bar.
• Integrated 7-inch resistive touchscreen interface provides real-time visualization of critical parameters: inlet pressure, retentate pressure, permeate pressure, flow rates (retentate & permeate), temperature, and accumulated permeate volume.
• Onboard data logging stores all process variables with time stamps and user identification—fully compliant with ALCOA+ principles and supporting 21 CFR Part 11 audit trail requirements when deployed in regulated environments.
• Compact footprint (W × D × H: 450 × 500 × 420 mm) and low power consumption (<300 W) make it suitable for standard laboratory fume hoods or cleanroom-adjacent spaces.

Sample Compatibility & Compliance

The ÄKTA flux 6 handles a broad range of biological feedstreams including clarified monoclonal antibody harvests, viral vector lysates, plasmid DNA solutions, vaccine antigen preparations, and stem cell culture supernatants. It supports molecular weight cutoffs from 1 kDa (ultrafiltration) to 0.2 µm (microfiltration), depending on installed membrane configuration. All wetted materials meet USP Class VI biocompatibility standards; tubing and connectors are certified for single-use or clean-in-place (CIP) reuse per manufacturer guidelines. The system aligns with ISO 9001 quality management systems and supports compliance with ICH Q5A, Q5B, and Q5D for biologics manufacturing. When integrated into validated workflows, it meets GLP and GMP documentation expectations for process characterization studies.

Software & Data Management

Process control and data handling are managed via Cytiva’s proprietary UNICORN software (v8.3 or later), which provides method-driven operation, electronic batch record (EBR) export, and seamless integration with enterprise LIMS or MES platforms. All logged data—including alarms, manual interventions, and calibration events—are stored in encrypted .csv and .xml formats with SHA-256 checksum verification. Audit trails record user actions, timestamped to the millisecond, and cannot be edited or deleted—ensuring full traceability for regulatory submissions. Optional UNICORN Connect enables remote monitoring and secure cloud-based data backup through Cytiva’s validated infrastructure.

Applications

• Concentration of labile proteins and enzymes prior to chromatographic capture steps.
• Buffer exchange of purified antibodies into formulation buffers under controlled pH and conductivity conditions.
• Clarification of high-turbidity CHO or HEK293 harvests using 0.2–0.45 µm microfiltration cassettes.
• Harvest of fragile exosomes or virus-like particles (VLPs) with minimal shear-induced aggregation.
• Scale-down modeling for TFF step transfer from clinical to commercial manufacturing, supported by Cytiva’s Process Development Services.
• Membrane screening studies comparing flux decline, rejection profiles, and cleaning efficiency across multiple vendors and MWCOs.

FAQ

What is the minimum recommended working volume for the ÄKTA flux 6?

The system is validated for reliable operation starting at 50 mL, enabling high-concentration-factor applications while maintaining accurate level sensing and pump responsiveness.
Can the ÄKTA flux 6 be integrated with ÄKTA pure or ÄKTA avant systems?

Yes—via UNICORN software coordination and shared network infrastructure, allowing synchronized method sequencing and unified data archiving across chromatography and filtration steps.
Does the system support single-use fluid paths?

All standard configurations are compatible with pre-sterilized, gamma-irradiated single-use kits (e.g., Cytiva’s ReadyToProcess TFF sets), eliminating cleaning validation burden for early-phase development.
Is remote access or cybersecurity hardening available?

UNICORN Connect offers role-based remote viewing and TLS 1.2–encrypted communication; full cybersecurity implementation follows IEC 62443-3-3 guidelines and includes configurable firewall rules and user authentication policies.
How does Cytiva support regulatory filings for processes developed on this system?

Cytiva provides qualification documentation packages (DQ/IQ/OQ), vendor-specific risk assessments, and change control notifications (CCN) to support FDA, EMA, and PMDA submissions—available upon request through your local Cytiva account manager.