
Core Design Philosophy
Gentle Low-Shear Flow Dynamics: Optimized cross-flow channel geometry minimizes hydrodynamic shear stress, avoiding unfolding, aggregation or activity loss of fragile protein therapeutics during concentration and diafiltration.
High Selectivity Membrane Customization: Offer a full spectrum of molecular weight cutoff membranes tailored to target protein sizes, achieving near-complete retention of desired biomolecules while efficient removal of salts, impurities and small molecular contaminants.
Closed Aseptic & Residue-Free Construction: All wetted flow paths adopt smooth dead-zero sanitary design, compatible with validated CIP/SIP cycles to eliminate cross-contamination and residual carryover between production batches.
Modular Scalable Deployment: Standardized membrane cassette housing and skid frame design support parallel module expansion, enabling seamless scale-up from laboratory trials to continuous commercial manufacturing without process revalidation.
Authoritative Global Compliance System
Bioprocess Sanitation Standards: Fully compliant with cGMP, ISPE sanitary design guides and ISO biocompatibility requirements; all contact materials feature low protein adsorption and certified pharmaceutical-grade safety.
Global Regulatory Alignment: Meet FDA, EMA and ICH downstream processing specifications for biotherapeutic purification, satisfying strict quality thresholds for biosimilars, vaccines and cell therapy intermediates.
End-to-End Data Integrity: Integrated control software adheres to 21 CFR Part 11 standards, capturing real-time trans-membrane pressure, flux, volume and conductivity data with immutable audit trails for full batch traceability.
Full-Scope Technology & Turnkey Service Package
Process Feasibility & Parameter Customization: Conduct lab-scale ultrafiltration trials to screen optimal membrane type, flux rate and diafiltration volume, outputting personalized process parameters for target protein recovery.
Integrated Skid & Automated Control Design: Assemble compact, plug-and-play ultrafiltration skids equipped with automatic buffer exchange, liquid level interlock, differential pressure alarm and remote data monitoring functions.
Sanitary Operation & Maintenance Support: Configure quick-disconnect membrane housings, self-draining piping and standardized CIP/SIP interfaces to simplify routine cleaning, membrane replacement and batch changeover.
Validation Dossiers & Long-Term Technical Backing: Supply complete equipment qualification documents, standard operating protocols and membrane performance verification reports, with ongoing technical support for process optimization and capacity expansion.