AMTK B-T Blood Processing Workstation

Overview

The AMTK B-T Blood Processing Workstation is an automated, benchtop liquid handling platform engineered for high-integrity sample preparation in biobanking, clinical research, and translational laboratories. It employs capacitive liquid level sensing combined with optical tube identification to non-invasively detect phase boundaries—serum, buffy coat, and erythrocyte layers—in anticoagulated or clotted whole blood within standard vacuum collection tubes. Based on real-time interface detection, the system executes precise aspiration and dispense operations under programmable height offsets, ensuring reproducible separation of blood components without cross-phase contamination. Designed to replace manual pipetting in ISO 20387-compliant biobank workflows, the B-T workstation minimizes operator exposure to biohazards while maintaining traceability through integrated 1D/2D barcode scanning at every transfer step.

Key Features

• Capacitive liquid-level detection technology for accurate, contactless identification of serum, buffy coat, and red blood cell interfaces in 5 mL and 10 mL vacuum tubes
• Automated tube-to-tube and tube-to-microplate transfers with configurable aspiration depth offsets per layer (e.g., +0.5 mm above serum/buffy interface, −1.0 mm into RBC pellet)
• Integrated high-resolution linear imager supporting EAN-13, Code 128, and QR code reading for primary tube and destination container tracking
• Three operational modes: (1) Tube-to-scanned EP tube rack (up to 8 racks, 16 tubes per rack), (2) Tube-to-microplate (up to 9 SBS-standard plate positions), and (3) Fully customizable workflow mapping via graphical protocol editor
• Onboard data logging with timestamped CSV export containing source tube ID, destination ID, aspirated volume per layer, layer thickness estimates, and operator login context
• Compliance-ready architecture: audit trail enabled, user role-based access control (admin/operator), and electronic signature support aligned with GLP/GCP documentation requirements

Sample Compatibility & Compliance

The B-T workstation accommodates standard evacuated blood collection tubes (BD Vacutainer®, Greiner Bio-One, Sarstedt) with rubber stoppers and nominal diameters of 13 mm. It supports EDTA, heparin, citrate, and serum separator tube (SST) formats. All fluidic pathways are constructed from medical-grade, autoclavable PTFE and polypropylene; no wetted metal surfaces contact samples. The system meets IEC 61000-6-2 (immunity) and IEC 61000-6-3 (emissions) standards. While not FDA-cleared as a diagnostic device, its data management features—including immutable CSV logs, barcode-driven chain-of-custody records, and configurable retention policies—support compliance with ISO 20387:2018 (biobanking), ISO/IEC 17025:2017 (testing labs), and EU Annex 11 (computerized systems validation).

Software & Data Management

Control and configuration are managed via AMTK’s proprietary BloodWork Suite v3.2—a Windows-based application with intuitive drag-and-drop protocol builder, real-time status dashboard, and multi-user credential management. All operations generate timestamped metadata stored locally in SQLite format and exportable as ISO 8601-compliant CSV files. Audit trails record user logins, protocol edits, run initiations, and error events with SHA-256 hashed integrity verification. Optional integration with LIMS platforms (via HL7 v2.5 or RESTful API) enables bidirectional sample ID synchronization and automated result ingestion. Data exports include full traceability: source tube barcode, destination container ID, layer-specific volumes, environmental sensor readings (temperature/humidity), and operator ID.

Applications

• Biobank sample processing: standardized aliquoting of serum, plasma, buffy coat, and RBC fractions into cryovials or 96-well plates for long-term storage
• Clinical trial sample management: high-throughput preparation of matched biospecimen sets across multiple collection sites with minimal inter-operator variability
• Reference laboratory QC: reproducible generation of control materials (e.g., pooled serum panels) with documented layer recovery yields
• Translational research workflows: integration with downstream nucleic acid extraction or proteomic analysis platforms via standardized plate layouts
• Regulatory submissions: generation of ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) compliant data packages for FDA IND/IDE or EMA CTA dossiers

FAQ

Does the B-T workstation support integration with existing LIMS or LIS systems?
Yes—via optional HL7 v2.5 messaging or RESTful JSON API for bidirectional sample ID exchange, status updates, and result file ingestion.
Can the system process tubes with clot activators or gel separators?
Yes; optical and capacitive sensing reliably distinguishes serum/gel interfaces in SST tubes, provided gel integrity is maintained during centrifugation and transport.
Is calibration required before each run?
No routine recalibration is needed. System self-verifies liquid level detection accuracy using factory-trimmed reference electrodes and performs daily startup diagnostics on barcode readers and motion encoders.
What safety certifications does the instrument hold?
It complies with IEC 61010-1 (safety requirements for electrical equipment) and carries CE marking under the EU Medical Device Regulation (MDR) Annex XVI for ancillary biobanking equipment.
How is software validation handled for GxP environments?
AMTK provides a complete IQ/OQ/PQ validation package—including test scripts, evidence templates, and URS alignment documentation—designed for direct use in FDA 21 CFR Part 11 and EU GMP Annex 11 audits.