Description
Scalable Single-Use Centrifugation with Ksep®400-OPC
Ksep®400-OPC for Continuous, Automated Bioprocessing
The Ksep®400-OPC system from Sartorius is a high-performance, single-use centrifugation platform engineered for the continuous, gentle, and scalable separation of cells and particles in modern biomanufacturing. Designed for applications such as cell therapy, vaccine production, recombinant proteins, and blood processing, Ksep®400-OPC supports sterile, high-yield operations with built-in features that ensure process integrity and regulatory compliance. With OPC integration, it also enables secure data exchange and digital batch documentation to meet cGMP standards.
Key Features and Benefits
Continuous Non-Stop Discharge:Patented bowl design enables discharge without stopping rotation, supporting uninterrupted and sterile processing.
Automated and Manual Operation:Offers full automation with the option for manual control to meet varying process requirements.
Inbuilt Modularity:Designed to support Pilot-scale through to large-scale operations, processing up to 200 L of culture volume.
Gentle on Cells:Low shear environment preserves cell viability and minimizes intracellular contamination, ideal for sensitive cultures.
Closed, Single-Use Design:Uses pre-sterilized, USP Class VI-compliant consumables to ensure product efficacy and prevent cross-contamination.
Advanced Applications
Cell therapy manufacturing
Vaccine and recombinant protein production
Harvesting of high-density cultures ( › 100 million cells ⁄ mL)
Microcarrier-based and suspension cultures
Data Integrity and cGMP Compliance
OPC Connectivity:Integrates seamlessly with external server systems via OPC for real-time data transfer and system monitoring.
Batch Records Management:Facilitates digital creation, maintenance, and export of batch documentation for audit readiness.
Unified Software Platform:Consistent user interface across all Ksep systems reduces training and validation efforts.
Secure, Traceable Operation:Supports data integrity through user access controls and compliant electronic records handling.
Technical Specifications
Processing Volume: Up to 200 L depending on cell density
Modularity: Supports small to large-scale processing within the same platform
Contact Materials: Single-use, USP Class VI compliant
Operation Mode: Continuous, closed-loop, sterile-compatible
The Ksep® 400-OPC offers a flexible, GMP compliant, and scalable solution for biomanufacturing workflows - delivering high recovery, low shear, and efficient processing from pilot through to commercial scale.
