
Core Design Philosophy
Low-Damage Gentle Flow Channel Architecture: Optimized disc spacing, inlet flow velocity and chamber fluid dynamics minimize mechanical shear stress, avoiding denaturation, aggregation and activity loss of fragile antigens, protein therapeutics and live microbial strains.
Fully Sealed Aseptic Containment Framework: Integrated closed feed, separation and discharge pipelines isolate external airborne contaminants; reserved SIP steam ports support online in-place sterilization to eliminate cross-contamination risks between production batches.
Automated Timed Turbidity-Linked Deslagging: Intelligent automatic slag discharge triggered by preset time or real-time feed turbidity thresholds eliminates frequent manual chamber opening, lowering microbial exposure risks and enabling non-stop continuous production.
Modular Skid-Integrated Compact Layout: Unified unit structure with standardized utility, sampling and monitoring interfaces allows direct docking with bioreactors, buffer preparation skids and depth filtration systems without large-scale facility reconstruction.
Authoritative Global Compliance System
Pharmaceutical Sanitary Design Standards: Wetted components adopt mirror-polished 316L pharmaceutical stainless steel with ultra-low biomolecule adsorption, fully compliant with cGMP and ISPE sanitary equipment guidelines, compatible with validated CIP/SIP cycles.
Global Biomanufacturing Regulatory Alignment: Conforms to FDA, EMA and ICH quality control requirements for biologic raw material separation, satisfying rigorous bioburden and impurity limit thresholds for injectable drugs and vaccines.
Comprehensive Data Integrity Governance: Matching automation system meets 21 CFR Part 11 compliance criteria, recording real-time rotational speed, feed flow, operating temperature and deslagging cycles with tamper-proof, retrievable audit trails for full batch traceability.
Full-Lifecycle Customization & Turnkey Service Package
Process Feasibility & Custom Parameter Matching: Conduct lab separation trials based on feedstock turbidity, solid content and target product characteristics, customizing disc stack layout, rotational speed and automatic deslagging operation logic.
Sanitary Auxiliary System Integration Design: Deliver supporting design for sterile feeding pipelines, biological waste inactivation circuits and online cleaning manifolds to form a fully closed separation process loop.
On-Site Commissioning, Debugging & Operator Training: Complete pipeline connection, full-system performance tuning and standardized operation training to maximize separation efficiency and reduce unplanned production downtime.
Complete Validation Dossiers & Long-Term Technical Support: Supply full IQ/OQ/PQ qualification documents, equipment maintenance manuals and performance verification reports, with ongoing consultation for process optimization, model upgrading and spare parts supply.