This integrated turnkey skid is engineered for automated, cGMP-compliant formulation, dissolution, mixing, heating/cooling, sterilisation, holding and transfer of cell culture media, feeding solutions, chromatography buffers and process aqueous solutions across the entire biomanufacturing workflow.
Built around jacketed 316L stainless steel preparation vessels, the compact skid integrates sanitary agitators, spray ball CIP assemblies, temperature/pH/level transmitters, load cell weighing modules, diaphragm valve manifolds, recirculation loops and PLC automated control system as a unified unit. The thermal jacket enables accurate temperature regulation for powder dissolving, heat treatment and post-formulation cooling, while integrated weighing eliminates manual batching errors and guarantees consistent solute concentration batch after batch.
Fully pre-assembled, wired and factory-tested prior to delivery, the skid arrives ready for on-site connection to utilities, drastically shortening installation, qualification and validation cycles. The closed fluid pathway avoids open handling risks and microbial contamination; full data logging, audit trails and electronic signature functionality satisfy 21 CFR Part 11 data integrity requirements, with complete MTR, weld qualification and FAT/SAT documentation supplied for regulatory audits.
Modular design supports flexible capacity expansion and seamless pairing with single-use bioreactors, perfusion systems and downstream purification lines. Suitable for clinical trial material production and commercial-scale biologic manufacturing including mAbs, viral vectors and cell therapies, it cuts manual labour, reduces solution batch variability and standardises upstream & downstream liquid preparation workflows end-to-end.
