Sartorius Vivaflow® Tangential Flow Filtration (TFF) Cassettes

Overview

The Sartorius Vivaflow® series comprises modular, benchtop-scale tangential flow filtration (TFF) cassettes engineered for efficient concentration and buffer exchange of biologics in research and process development laboratories. Unlike dead-end filtration, TFF maintains laminar cross-flow across the membrane surface, minimizing fouling and enabling high recovery of sensitive biomolecules—including monoclonal antibodies, viral vectors, recombinant proteins, and nanoparticles. The Vivaflow® platform leverages optimized fluid dynamics and low-binding membrane chemistries to deliver reproducible performance with minimal sample loss and shear stress. Each cassette integrates inlet, outlet, and retentate ports in a compact, self-contained housing—requiring only a standard peristaltic pump and basic tubing setup for immediate deployment. Designed for flexibility, the system supports both single-use (Vivaflow 50) and reusable (Vivaflow 50R and Vivaflow 200) configurations, accommodating volumes from 0.1 mL to 5 L via parallel or serial operation.

Key Features

• Modular scalability: Up to six Vivaflow 50 cassettes can be operated in parallel or series to increase throughput without re-optimization.
• Low-protein-binding Hydrosart® membrane (Vivaflow 50R and Vivaflow 200): Chemically modified regenerated cellulose offering superior recovery of high-value biologics such as IgG, AAV, and lentiviral particles.
• Dual-membrane compatibility: Vivaflow 200 supports both Hydrosart® and hydrophilic polyethersulfone (PES) membranes—enabling method transfer between purification stages or validation workflows.
• Precision molecular weight cut-off (MWCO) selection: Available in discrete MWCOs from 2 kDa to 1,000 kDa, plus 0.2 µm microfiltration variants for clarification or sterile-grade processing.
• Robust, autoclavable housing (Vivaflow 50R/Vivaflow 200): Withstands repeated cleaning-in-place (CIP) and steam sterilization (SIP), supporting GMP-aligned reuse under documented procedures.
• Minimal hold-up volume (< 0.5 mL): Reduces sample loss and enables near-complete recovery—critical for low-yield viral preps or clinical-grade material.

Sample Compatibility & Compliance

Vivaflow® cassettes are validated for use with a broad range of biological feedstreams, including clarified mammalian cell culture supernatants, insect cell lysates, bacterial periplasmic extracts, plasma-derived fractions, and environmental virus concentrates. The Hydrosart® membrane exhibits low non-specific binding across pH 3–12 and is compatible with common formulation buffers (e.g., PBS, Tris-HCl, histidine, acetate) and mild sanitizing agents (e.g., 0.1–0.5 M NaOH). All Vivaflow® products are manufactured in ISO 13485-certified facilities and supplied sterile-filtered (0.2 µm) or gamma-irradiated where applicable. Device documentation supports compliance with ICH Q5A(R2), USP , and FDA 21 CFR Part 11 when integrated into validated software-controlled TFF workflows. Reusable units support traceable maintenance logs and meet GLP/GMP requirements for equipment qualification (IQ/OQ/PQ).

Software & Data Management

While Vivaflow® operates independently of proprietary controllers, it is fully compatible with third-party peristaltic pump systems featuring programmable flow rate profiles, pressure monitoring, and data logging (e.g., Watson-Marlow, Masterflex L/S). For regulated environments, integration with LIMS or ELN platforms is achieved via analog/digital I/O or Modbus RTU interfaces. Audit trails for operating parameters—including transmembrane pressure (TMP), flux rate, total processed volume, and run duration—can be captured and archived to satisfy 21 CFR Part 11 electronic record requirements. Sartorius provides comprehensive technical documentation packages—including Declaration of Conformity, Biocompatibility Reports (ISO 10993-5/-10), and extractables/leachables summaries—for inclusion in regulatory submissions.

Applications

• Concentration and diafiltration of therapeutic monoclonal antibodies (mAbs) and Fc-fusion proteins during early-stage process development.
• Downstream processing of viral vectors (AAV, LV, RV) with preservation of infectivity titer and particle integrity.
• Rapid desalting and buffer exchange of enzymatically digested samples prior to LC-MS analysis.
• Pre-concentration of low-titer biologics from large-volume cell culture harvests (e.g., hybridoma supernatants, transient transfection batches).
• Nanoparticle purification and size-based fractionation of liposomes, exosomes, and polymeric micelles.
• Environmental virology: Concentration of waterborne viruses (e.g., norovirus, adenovirus) from 1–10 L samples for PCR or TEM analysis.

FAQ

What is the maximum recommended transmembrane pressure (TMP) for Vivaflow® cassettes?
Maximum TMP is 2.5 bar (36 psi) for all models; sustained operation above 2.0 bar requires real-time pressure monitoring to prevent compaction or membrane damage.

Can Vivaflow® cassettes be used for sterile filtration?
Vivaflow® 50 and Vivaflow 200 with 0.2 µm PES membranes are suitable for sterile-grade clarification but are not validated as final sterile filters per ASTM F838; use in conjunction with a 0.22 µm sterilizing-grade filter for aseptic processing.

How should reusable Vivaflow® units be cleaned and stored?
Post-use, rinse with deionized water followed by 0.1 M NaOH (30 min, RT), then neutralize with 0.1 M HCl and store in 20% ethanol. Validate cleaning efficacy per SOP using BSA or IgG recovery assays.

Is MWCO guaranteed across all flow rates and pressures?
MWCO values are determined under standardized conditions (20°C, 1 bar TMP, dextran calibration); actual retention may vary with solute conformation, ionic strength, and shear history—empirical testing is recommended for critical applications.

Are Vivaflow® cassettes compatible with organic solvents?
PES membranes tolerate ≤10% v/v ethanol, isopropanol, or acetonitrile; Hydrosart® membranes are aqueous-phase only. Avoid DMSO, DMF, chlorinated solvents, and strong oxidizers.