This fully automated inline buffer formulation skid is purpose-built for biopharmaceutical downstream purification workflows, delivering continuous, on-demand, real-time preparation of chromatography elution buffers, wash buffers, neutralisation solutions and pH-adjusted process liquids without intermediate holding tanks.
Adopting precise mass flow & volumetric proportioning technology, the system automatically meters concentrated stock solutions, purified water for injection (WFI) and pH modifiers in set ratios, executing inline mixing and homogenisation directly within the process pipeline. Integrated inline pH, conductivity and temperature sensors conduct real-time closed-loop feedback correction, guaranteeing consistent buffer composition, ionic strength and pH value batch after batch, eliminating manual weighing, batching and tank storage errors inherent to traditional tank-based preparation modes.
The entire wetted flow path uses sanitary 316L stainless steel or single-use compatible components, supporting automated CIP/SIP and full closed operation to avoid contamination risks. Built as a compact pre-assembled skid with PLC+HMI central control, complete recipe management, batch data logging, audit trails and electronic signature functions fully comply with cGMP and 21 CFR Part 11 data integrity requirements.
Factory FAT pre-testing shortens on-site SAT and commissioning cycles, and the modular structure enables seamless inline docking directly with chromatography systems, tangential flow filtration and other downstream units. It drastically cuts buffer storage tank footprint, reduces solution waste and manual labour costs, simplifies validation workloads, and enables uninterrupted continuous purification production for monoclonal antibodies, recombinant proteins and viral vector manufacturing lines.
