Hamilton easyBlood STARline Automated Blood Fractionation Workstation

Overview

The Hamilton easyBlood STARline is a fully automated, CE-marked blood fractionation workstation engineered for high-integrity separation and dispensing of whole blood into its constituent layers—plasma, buffy coat (leukocyte-rich interface), and erythrocyte fractions—under controlled, traceable laboratory conditions. It operates on the principle of vision-guided, real-time stratification detection: integrated high-resolution cameras continuously monitor tube cross-sections during centrifugation-equilibrated decanting, enabling precise optical discrimination of phase boundaries based on optical density gradients. This eliminates manual visual estimation and mitigates inter-operator variability—a critical requirement for biobanking, clinical trial sample processing, and translational research where buffy coat recovery fidelity directly impacts downstream genomic or immunophenotypic assay performance.

Key Features

• Vision-based layer recognition system with sub-millimeter spatial resolution, calibrated for human whole blood at standard hematocrit ranges (35–45%) and common anticoagulants (EDTA, citrate, heparin)
• Modular pipetting architecture: configurable 4-channel or 8-channel STAR/STARlet liquid handling engines supporting simultaneous multi-layer aspiration with independent tip control
• Full traceability via integrated 2D barcode readers for primary tubes, racks, and consumables (e.g., Sarstedt, Greiner Bio-One certified tubes)
• iSWAP robotic arm integration for seamless plate-to-plate transport between centrifuge, storage, and analysis modules
• easyCode carrier identification system enabling automatic deck layout mapping and dynamic reconfiguration without manual calibration
• Robust mechanical architecture compliant with ISO 13485:2016 design controls and validated for continuous operation in Class II biosafety environments

Sample Compatibility & Compliance

The easyBlood STARline accommodates standard 13 × 100 mm and 16 × 100 mm evacuated blood collection tubes (including BD Vacutainer®, Sarstedt Monovette®), as well as 96-well and 384-well ANSI/SLAS-format microplates. All fluidic pathways are constructed from USP Class VI-certified chemically resistant polymers; disposable tips comply with ISO 8655-8 for volumetric accuracy verification. The system supports full audit trail generation per FDA 21 CFR Part 11 requirements—including electronic signatures, user-level access control, and immutable event logging—and is pre-validated against ASTM E2500-13 (Good Automated Manufacturing Practice) and ISO/IEC 17025:2017 clause 5.9 (method validation for automated sample preparation).

Software & Data Management

Controlled by Hamilton’s VENUS software v3.5+, the platform provides GxP-aligned workflow scripting with drag-and-drop protocol builder, real-time process visualization, and embedded QC checkpoints (e.g., volume reconciliation, layer integrity flagging). All raw image data, pipetting logs, barcode scans, and environmental metadata (timestamp, operator ID, ambient temperature) are stored in encrypted SQLite databases with optional DICOM/SOP-compatible export. Integration with LIMS (e.g., LabVantage, Thermo Fisher SampleManager) is achieved via HL7 v2.5.1 and RESTful API endpoints supporting JSON-formatted sample manifest ingestion and status polling.

Applications

• Biobank-scale processing of longitudinal cohorts requiring standardized buffy coat isolation for DNA/RNA extraction and cryopreservation
• Pre-analytical standardization in multicenter clinical trials governed by ISO 20387:2018 biobanking requirements
• Automated plasma fractionation for therapeutic protein quantification (e.g., ELISA, LC-MS/MS) under GLP conditions
• High-throughput PBMC isolation workflows interfaced with downstream cell sorting or flow cytometry platforms
• Regulatory submission support: documented IQ/OQ/PQ protocols available upon request for FDA BLA/MAA dossiers

FAQ

Does the system require pre-centrifuged samples?
Yes—samples must be centrifuged using validated protocols (e.g., 1500 × g for 10 min at 20 °C) prior to loading. The workstation does not include an integrated centrifuge.
Can it handle clotted blood (serum separation)?
No—the optical detection algorithm is optimized for anticoagulated whole blood. Serum separation requires separate hardware configuration and is not supported in the current easyBlood STARline release.
Is validation documentation provided?
Hamilton supplies comprehensive vendor-provided IQ/OQ documentation aligned with ISO 15189 and CLIA standards; site-specific PQ execution support is available through certified field application specialists.
What maintenance intervals are recommended?
Daily tip ejection check, weekly camera lens cleaning, and quarterly pipetting accuracy verification using gravimetric methods per ISO 8655-6 are advised. Preventive maintenance service contracts include annual calibration and firmware updates.