This fully automated skid-mounted system is engineered for accurate, reproducible formulation, dissolution, pH adjustment, filtration and sterile transfer of cell culture media, buffer solutions and feed supplements, serving as the upstream core supporting unit for mAb, vaccine, viral vector and cell therapy biomanufacturing.
All wetted components are electropolished 316L stainless steel with seamless orbital welding, validated via full E&L testing and compatible with automated CIP/SIP cycles, strictly complying with global cGMP standards. High-precision solid powder feeding modules and liquid dosing pumps eliminate manual weighing and material transfer errors, precisely executing ingredient addition sequences according to pre-stored recipes. Online pH, conductivity and temperature sensors conduct real-time closed-loop correction, guaranteeing batch-to-batch consistency of osmolarity, pH value and ion concentration of prepared media.
Integrated sterile depth filtration or membrane filtration units complete bioburden control inline, delivering ready-to-use sterile culture media directly to bioreactors through closed pipeline distribution, fully avoiding open operation and exogenous contamination risks. The control system adheres to ISA-88 batch management specifications, supports one-click recipe switching for diverse basal media, feed media and induction supplements, unattended full-cycle operation, real-time data logging and immutable audit trails, satisfying data integrity requirements for regulatory submission.
Factory pre-assembly and complete FAT testing drastically shorten on-site installation and validation cycles. The modular layout allows flexible capacity expansion and seamless interconnection with bioreactor suites, perfusion systems and downstream purification skids. It effectively cuts labor costs, reduces raw material waste and stabilizes upstream cell culture performance, ideal for both pilot process development and large-scale commercial biopharmaceutical production workshops.
