Eureka Bio CellSep Pro Automated Cell Processing System

Overview

The Eureka Bio CellSep Pro Automated Cell Processing System is a fully enclosed, programmable centrifugation-based platform engineered for reproducible, GMP-aligned cell isolation, enrichment, washing, concentration, and formulation in clinical and translational cell therapy workflows. It operates on the principle of piston-driven gradient centrifugation—leveraging precise fluidic control, real-time mass sensing, and synchronized mechanical actuation to separate heterogeneous cell populations within sterile, single-use closed tubing sets. Unlike conventional benchtop centrifuges or manual density-gradient protocols, the CellSep Pro eliminates open-handling steps by integrating sample loading, layer separation, fraction aspiration, and collection into a single automated sequence under ISO Class 5 (or better) environmental conditions. Its architecture supports scalable processing—from research-grade PBMC isolation to manufacturing-ready batch preparation—while maintaining strict adherence to aseptic integrity, operator safety, and process consistency.

Key Features

• Fully enclosed, single-use tubing sets with integrated piston-driven centrifugal chambers, rotary three-way valves, sterile filters, and segregated collection bags.
• Automated gravimetric dosing via high-resolution load cells ensures accurate sample introduction (±0.5% accuracy over 10–500 mL range).
• Programmable centrifugation parameters—including speed (up to 2,800 × g), duration (1–60 min), acceleration/deceleration profiles, and rotor orientation—for protocol-specific optimization.
• Onboard software compliant with 21 CFR Part 11 requirements, featuring electronic signatures, audit trails, user role management, and immutable data logging.
• CE-marked design validated for use in cleanroom environments (ISO 14644-1 Class 5 compatible when operated within biological safety cabinets or isolators).
• Modular hardware interface supporting custom tube set development and third-party integration (e.g., upstream activation modules or downstream cryopreservation units).

Sample Compatibility & Compliance

The CellSep Pro accommodates a broad spectrum of primary human samples—including peripheral blood, bone marrow aspirates, umbilical cord blood, and adipose-derived stromal vascular fraction—using application-specific disposable kits. Each kit is gamma-irradiated, DNase/RNase-free, and certified endotoxin-low (<0.25 EU/mL). The system meets ISO 13485:2016 quality management standards for medical device manufacturers and aligns with key regulatory expectations for cell therapy process validation, including ICH Q5A(R2), USP <1043>, and ASTM F3219-17 guidelines for closed-system performance verification. All process records—including timestamps, parameter logs, sensor outputs, and operator actions—are retained in encrypted SQLite databases with optional export to LIMS or MES platforms.

Software & Data Management

The embedded CellSep Control Suite provides intuitive workflow configuration through drag-and-drop protocol builders, preloaded templates (e.g., “PBMC Isolation v2.1”, “Wash & Resuspend Standard”), and version-controlled method libraries. Every run generates a complete digital batch record containing raw sensor data, event logs, alarm history, and PDF-certified summary reports. Audit trail functionality captures who performed each action, when it occurred, and what changes were made—supporting FDA inspections, EMA Annex 11 assessments, and internal GLP/GMP audits. Remote monitoring and secure cloud backup options are available via optional enterprise licensing.

Applications

• Isolation of peripheral blood mononuclear cells (PBMCs) from 30–150 mL whole blood using Ficoll-Paque™ or equivalent density media.
• Enrichment of hematopoietic stem/progenitor cells (HSPCs) from bone marrow or mobilized peripheral blood.
• Processing of umbilical cord blood units for CD34+ selection and cryobank readiness.
• Concentration and buffer exchange of expanded T-cell products prior to formulation and cryopreservation.
• Automated post-thaw washing and viability assessment support for allogeneic or autologous cell therapies.
• Scalable process development for Phase I–III clinical trial material production under current Good Manufacturing Practice (cGMP) conditions.

FAQ

Does the CellSep Pro support temperature-controlled processing?
No—the system operates at ambient laboratory temperature (18–25°C) and does not incorporate active heating or cooling elements. For temperature-sensitive applications, users must precondition samples and consumables prior to loading.

Are the disposable tubing sets supplied sterile and ready-to-use?
Yes—all tube sets undergo terminal gamma irradiation (25–35 kGy), are individually blister-packed, and include full bioburden and endotoxin test certificates per ISO 11737-1 and USP <85>.

Can the system be integrated into an existing cleanroom automation infrastructure?
Yes—via Modbus TCP and OPC UA interfaces, the CellSep Pro supports bidirectional communication with SCADA systems, PLCs, and central monitoring platforms for facility-wide process orchestration.

What regulatory documentation is provided with the system?
Each shipment includes CE Declaration of Conformity, ISO 13485 certificate, Risk Management File (per ISO 14971), Design History File summary, and Installation/Operational Qualification (IQ/OQ) protocols aligned with Annex 15 of the EU GMP Guide.