AZENTA Cryo Store Pico™ Automated LN₂-Based Cryogenic Storage System at –190°C

Overview

The AZENTA Cryo Store Pico™ is an automated, vapor-phase liquid nitrogen (LN₂) cryogenic storage system engineered for long-term preservation of high-value biological specimens—including cell therapies, primary tissues, stem cells, and clinical-grade biologics—at a stable –190°C operating temperature. Unlike conventional mechanical freezers or passive dewars, the Cryo Store Pico employs a vertically oriented, insulated tower architecture with active LN₂ vapor distribution, ensuring uniform thermal profiles from top to bottom without direct liquid immersion. This vapor-phase design eliminates ice accumulation, minimizes cross-contamination risk, and maintains sample integrity below the glass transition temperature (T_g) of aqueous biological matrices throughout storage and retrieval cycles. Its compact footprint (under 8 ft / 2.42 m height) enables integration into standard-height laboratory or GMP-compliant cleanroom environments—bringing critical biobanking infrastructure closer to point-of-use while reducing manual handling, ergonomic strain, and ambient temperature excursions.

Key Features

• Vapor-Phase LN₂ Architecture: Delivers consistent –190°C across full chamber depth via controlled LN₂ vapor convection; validated thermal uniformity ±6°C (per thermocouple mapping per ASTM F2697).
• Sample-Level Integrity Protection: Integrated Sample Integrity Calculator uses empirical thermal modeling to predict transient warming during robotic retrieval, ensuring non-target vials remain below T_g (–135°C to –120°C for most aqueous cryoprotectant formulations).
• Redundant Critical Systems: Dual independent LN₂ supply lines, backup vacuum insulation monitoring, and fail-safe mechanical interlocks maintain ≥48-hour temperature hold during simultaneous loss of utility power and primary LN₂ feed.
• Ergonomic Human-Machine Interface: Motorized access door and vending-machine-style front panel eliminate bending, reaching, or prolonged exposure to cold surfaces; all sample manipulation occurs within the thermally isolated tower.
• Full-Traceability Inventory Engine: Barcode-scanned vial-level identification with time-stamped audit trail, user-defined access roles, and immutable event logging compliant with FDA 21 CFR Part 11 Annex 11 requirements.
• Modular Automation Readiness: Native support for integration with third-party LIMS (e.g., LabVantage, STARLIMS), robotic arms (e.g., Hamilton STAR, Tecan Fluent), and enterprise biorepository workflows via HL7/FHIR and RESTful API endpoints.

Sample Compatibility & Compliance

The Cryo Store Pico accommodates industry-standard cryogenic consumables including externally threaded 1.0–2.0 mL cryovials (Nunc, Thermo Fisher, Matrix), 96-well and 384-well cryo plates, cryoboxes (10×10, 8×12 formats), and custom rack configurations. All storage hardware is certified ISO 13485–compliant and manufactured under AZENTA’s QMS aligned with ICH-GCP, ISO 20387 (Biobanking), and USP /. The system supports dual-mode operation: fully automated robotic retrieval or manual override with mechanical safety release—ensuring continuity during maintenance or regulatory inspection. Temperature validation follows IQ/OQ/PQ protocols per ISO/IEC 17025, with annual calibration traceable to NIST standards. Data integrity controls include electronic signatures, role-based permissions, and encrypted database backups meeting HIPAA and GDPR technical safeguards.

Software & Data Management

CryoControl™ software serves as the central command interface, featuring a 10.1-inch capacitive touchscreen with glove-compatible UI and intuitive drag-and-drop workflow builder. It provides real-time visualization of chamber temperature gradients, LN₂ level, vacuum status, and robotic actuator health. All inventory actions—including check-in, location assignment, thaw request, and disposal—are logged with WHO-issued timestamp, operator ID, and contextual metadata (e.g., associated protocol ID, project code). Audit reports are exportable in PDF/A-2 or CSV format with cryptographic hash verification. LIMS synchronization occurs via bidirectional webhooks supporting asynchronous batch updates and conflict resolution logic. For regulated environments, the system delivers full 21 CFR Part 11 compliance: electronic records retention ≥30 years, ALCOA+ principles enforcement (Attributable, Legible, Contemporaneous, Original, Accurate), and configurable retention policies aligned with sponsor or institutional SOPs.

Applications

• Long-term archiving of autologous and allogeneic cell therapy products (CAR-T, NK cells, MSCs) under cGMP conditions.
• Supporting Phase I–III clinical trial biobanking with chain-of-custody documentation for FDA BLA submissions.
• High-throughput biorepository operations requiring >5,000 vial/day throughput with zero manual repositioning.
• Academic core facilities managing multi-cohort longitudinal studies with federated access control across departments.
• Contract development and manufacturing organizations (CDMOs) implementing digital twin-enabled cold chain validation.

FAQ

What is the validated temperature uniformity across the storage chamber?
Thermal mapping per ASTM F2697 confirms ±6°C deviation at steady state, with worst-case locations remaining ≤–184°C under full load and nominal LN₂ flow.
Does the system support both vapor-phase and liquid-phase operation?
No—Cryo Store Pico is exclusively vapor-phase optimized to prevent thermal shock, ice formation, and vial cracking; liquid-phase immersion is not supported or validated.
Can legacy cryoboxes and barcoded vials be used without modification?
Yes—compatible with ANSI/SLAS-compliant 2D DataMatrix codes on vial caps and standard SBS-format racks; no proprietary labeling required.
How is regulatory audit readiness maintained during software upgrades?
All firmware and application updates undergo formal change control per ISO 13485; versioned binaries and impact assessments are retained in the audit log with rollback capability.
Is remote monitoring and alarm notification available?
Yes—via AZENTA Cloud Connect (optional subscription), enabling SMS/email alerts for temperature excursions, LN₂ depletion, door-open events, and predictive maintenance triggers.