This fully automated tangential flow filtration (TFF) system is designed for biopharmaceutical concentration, buffer exchange, desalting and impurity removal, covering ultrafiltration (UF) and diafiltration (DF) core unit operations for monoclonal antibodies, recombinant proteins, viral vectors and cell therapy intermediates.
Equipped with precise flow, transmembrane pressure (TMP), crossflow rate and permeate flux closed-loop control modules, the platform runs programmed UF concentration and continuous diafiltration workflows automatically without frequent manual intervention. Real-time inline sensors monitor conductivity, pH and volume change, triggering automatic buffer replenishment and process endpoint judgment to guarantee consistent target protein concentration and complete buffer replacement batch to batch.
Sanitary 316L stainless steel wetted piping and configurable single-use flow path options are both available, fully compatible with automated CIP/SIP cycles and closed processing to mitigate contamination risks. Built on skid-mounted integrated layout with PLC+HMI operation interface, it supports recipe storage, one-click batch execution, full data logging, audit trails and electronic signatures, fully complying with cGMP and 21 CFR Part 11 data integrity standards.
Seamlessly dockable with upstream harvest equipment and downstream chromatography systems, the system effectively reduces product hold-up volume and yield loss, cuts process variability and validation workload. It fits lab-scale process development, pilot trials and commercial large-scale production simultaneously, serving as a standardised core concentration & buffer exchange workstation for modern biomanufacturing lines.
