ROCKER Tanfil100 Automated Tangential Flow Filtration (TFF) System

Overview

The ROCKER Tanfil100 is an automated, benchtop-scale tangential flow filtration (TFF) system engineered for precision, reproducibility, and operational simplicity in life science laboratories. Unlike dead-end filtration, TFF employs a cross-flow geometry where the feed stream flows parallel to the membrane surface—generating shear forces that minimize concentration polarization and fouling. This principle enables high-yield concentration, diafiltration, buffer exchange, and size-based separation of biomolecules—including proteins, nucleic acids (DNA/RNA), viruses, viral vectors, exosomes, and clarified lysates—without irreversible membrane clogging. The Tanfil100 integrates a peristaltic pump, pressure-sensing module, digital OLED interface, and chemically resistant fluid path into a compact, GMP-aligned architecture. Its design supports seamless method transfer from discovery through process development, with scalability validated via consistent operating parameters across lab-scale and pilot-scale TFF platforms.

Key Features

• Integrated automation: Single-unit configuration with real-time pressure monitoring, adjustable flow control (0–600 mL/min), and intuitive OLED interface—no external controllers or software required for basic operation.
• Low-volume processing: Supports minimum working volumes under 7 mL, enabling efficient handling of precious samples such as CRISPR ribonucleoprotein complexes or low-titer viral preps.
• Chemically robust wetted path: Fluid-contact materials include USP Class VI-certified Pharmed® BPT tubing, PES reservoir, SS316 pressure sensors and Luer fittings, and silicone/NBR elastomers compliant with ISO 10993 biocompatibility standards.
• Interchangeable cassette compatibility: Designed for industry-standard single-use TFF cassettes—including Pall Minimate™ (Omega modified polyethersulfone membranes), Sartorius Sartocon Slice 50, and Merck Pellicon® XL 50—supporting MWCOs from 650 Da to 1,000 kDa.
• Enhanced membrane longevity: Optimized flow dynamics reduce cake formation and maintain >90% flux stability over multiple cycles when operated within recommended transmembrane pressure (TMP) limits.
• Safety-certified engineering: CE-marked and RoHS-compliant; includes motor overload cutoff at 40 psi and redundant thermal/fuse protection aligned with IEC 61010-1 safety requirements for laboratory equipment.

Sample Compatibility & Compliance

The Tanfil100 accommodates diverse biological feed streams—including mammalian cell culture supernatants, bacterial lysates, fermentation broths, plasma fractions, and nucleic acid eluates—across pH 1–14 when used with Omega®-series PES membranes. All wetted components meet USP Class VI and ISO 10993-5 cytotoxicity criteria. The system supports GLP/GMP-aligned workflows: pressure logging (via analog gauge), manual parameter recording, and traceable cassette lot documentation facilitate audit readiness. While the Tanfil100 itself does not include electronic audit trails or 21 CFR Part 11 compliance features, its mechanical design and material certifications align with upstream validation requirements for purification process development under ICH Q5A, Q5D, and ISO 22442-1 (for animal-derived reagents).

Software & Data Management

The Tanfil100 operates without proprietary software—relying on embedded firmware and direct hardware control for reliability and reduced IT validation burden. Pressure readings (up to 80 psi) and flow rate settings are displayed in real time on the OLED screen. Users manually record critical parameters—including initial/final volume, TMP, cumulative processing time, and cassette batch number—in laboratory notebooks or ELN systems. For advanced data capture, analog pressure output (0–5 V) is available via optional interface modules compatible with third-party DAQ systems (e.g., National Instruments CompactDAQ). No cloud connectivity, remote access, or firmware update capability is provided—ensuring air-gapped operation where required by institutional cybersecurity policies.

Applications

• Concentration & diafiltration of monoclonal antibodies (mAbs), Fc-fusion proteins, and bispecifics prior to analytical characterization or formulation screening.
• Buffer exchange of CRISPR-Cas9 RNP complexes into electroporation-compatible media while preserving nuclease activity.
• Virus removal and purification: Clarification of lentiviral or AAV harvests using 0.1 µm or 0.2 µm pore-rated cassettes, followed by concentration to ≥1×10¹³ vg/mL titers.
• Exosome isolation from serum or conditioned media via sequential 0.45 µm pre-filtration and 100 kDa MWCO TFF—enabling recovery yields >75% compared to ultracentrifugation.
• Removal of endotoxins and host-cell proteins (HCPs) from recombinant protein preparations using optimized diafiltration protocols with low-salt buffers.
• Scale-down modeling: Reproducing full-scale TFF process conditions (shear rate, TMP, residence time) for tech transfer to manufacturing suites equipped with KrosFlo or ÄKTA Flux systems.

FAQ

What types of TFF cassettes are supported?
The Tanfil100 accepts standard 50 cm² footprint cassettes including Pall Minimate™ TFF, Sartorius Sartocon Slice 50, and Merck Pellicon® XL 50 devices. Membrane chemistries include Omega® PES, regenerated cellulose, and polyvinylidene fluoride (PVDF), with MWCO options ranging from 650 Da to 1,000 kDa.
Can the system perform continuous diafiltration?
Yes—by connecting an auxiliary buffer reservoir to the feed inlet via gravity-fed or peristaltic-assisted addition, users can execute controlled diafiltration protocols with real-time monitoring of conductivity or UV absorbance using external inline sensors.
Is the 500 mL reservoir autoclavable?
No—the PES reservoir is not autoclavable. Sterilization is achieved via gamma irradiation of pre-assembled, single-use cassettes and chemical sanitization (e.g., 0.5 M NaOH) of the fluid path per SOP.
What maintenance is required?
Routine cleaning-in-place (CIP) with 0.5 M NaOH (30 min, 25°C) followed by DI water rinse is recommended between runs. Tubing should be replaced every 200–300 hours of cumulative operation or upon visible deformation.
Does ROCKER provide method development support?
Yes—application notes, cassette selection guides, and protocol templates for common biomolecules (e.g., IgG concentration, plasmid DNA diafiltration) are available upon request from ROCKER Technical Services.