Sartoflow(r) 5000 SU

The Sartoflow^® 5000 SU tangential flow filtration system delivers advanced automation and instrumentation for ultrafiltration, diafiltration, and microfiltration processes in biopharmaceutical production environments. This commercial-scale solution combines superior performance with operational efficiency in a compact footprint, supporting diverse applications from monoclonal antibodies to viral vectors for gene therapy.

The system integrates hardware, control systems, and single-use flow kits to function cohesively across different process requirements. Its configurable design accommodates up to 14 m² cassette area (21 m² option available) and hollow fiber modules up to 5 m², enabling minimal working volumes of approximately 6.9 L. The pressure drop-optimized design maximizes throughput while maintaining product quality and recovery rates.

Powered by Biobrain^® automation platform, the system provides fully automated TFF process sequences with pre-defined recipes and customizable operational parameters. The modular software architecture ensures cGMP readiness and compliance with industrial standards including GAMP 5, Category 4, CFR21 Part 11, and ISA-88. Built on Siemens Simatic® S7-1500 PLC foundation, the control system offers reliable operation with seamless integration to higher-level DCS and MES platforms through OPC UA support.

Single-use components manufactured in ISO 14644-1 Class 7 clean room facilities feature innovative multi-block valve technology that streamlines setup procedures. The Flexsafe^® Pro Mixer bags, available in 50, 200, and 400 L volumes (further sizes available), incorporate optimized tubing positioning and integrated sensors for conductivity, pH, and temperature monitoring. Components in fluid contact utilize platinum-cured silicone, polypropylene, and other materials engineered to withstand challenging conditions across different modalities.

The system operates within 4-40 °C temperature ranges with precise control capabilities from 10-40 °C. Comprehensive instrumentation includes pressure measurement, flow measurement for retentate and permeate, UV detection at dual wavelengths (254 and 280 nm), and conductivity and pH monitoring across multiple ranges. These capabilities support critical process monitoring and control for consistent product quality.