
Core Design Philosophy
Low-Damage Gentle Separation Structure: Optimized disc spacing and flow velocity reduce mechanical shear force, preventing denaturation, aggregation and activity degradation of sensitive antigens, proteins and live microbial strains.
Fully Enclosed Aseptic Operation Framework: Sealed feed, separation and discharge channels isolate external pollutants; sterile steam interfaces support online sanitization to eliminate cross-contamination risks between batches.
Automated Continuous Slag Discharge System: Timing and turbidity-linked automatic deslagging avoids manual opening of separation chambers, lowering microbial exposure risk while sustaining uninterrupted production.
Compact Footprint Modular Layout: Integrated unit structure with reserved utility and monitoring interfaces enables seamless docking with bioreactor tanks, depth filtration skids and buffer preparation systems without major facility reconstruction.
Authoritative Global Compliance System
Pharmaceutical Sanitation Specifications: Wetted components adopt low-adsorption biocompatible stainless steel with mirror polishing, fully compliant with cGMP and ISPE sanitary equipment design guidelines, compatible with validated CIP/SIP procedures.
Biomanufacturing Regulatory Alignment: Conforms to FDA, EMA and ICH quality standards for biologic raw material separation, meeting stringent purity and bioburden control thresholds for injectable drugs and vaccines.
Full Data Integrity Architecture: Equipped with 21 CFR Part 11-compliant control systems, real-time recording rotational speed, feed flow, temperature and deslagging cycles with tamper-proof audit trails for full batch traceability.
Full-Lifecycle Customization & Turnkey Services
Process Matching & Customized Parameter Configuration: Conduct lab separation trials according to customer fermentation liquid turbidity, solid content and target product characteristics, customizing disc stack structure, rotating speed and automatic deslagging logic.
Sanitary System Integration & Auxiliary Matching: Complete supporting design of sterile feeding pipelines, waste residue inactivation pipelines and online cleaning circuits to form a fully closed separation process loop.
On-Site Commissioning, Operation & Maintenance Training: Provide professional equipment debugging, process parameter optimization and operator training to ensure stable continuous operation and reduce unexpected downtime.
Validation Documentation & After-Sales Technical Support: Deliver full equipment qualification dossiers, performance verification reports and standard operation manuals, offering long-term upgrades, spare parts supply and process optimization consultation.