Thermo Scientific Arctic Express™ Cryogenic Transport System

Overview

The Thermo Scientific Arctic Express™ Cryogenic Transport System is an engineered solution for the safe, compliant, and temperature-stable transport of biologics, infectious agents, and other temperature-sensitive biological materials at cryogenic temperatures (≤ −150 °C). Designed in accordance with UN 3373 (Biological Substance, Category B) and IATA Dangerous Goods Regulations (DGR), the system leverages phase-change absorption technology to immobilize liquid nitrogen within a proprietary matrix—eliminating free liquid movement while maintaining consistent thermal performance over extended durations. Unlike passive dry vapor shippers relying solely on insulation, the Arctic Express integrates a validated absorbent core that retains LN₂ in a gel-like state, enabling reliable 8-, 13-, or 21-day hold times without active refrigeration or external power. This architecture ensures continuous thermal stability across air, ground, and intermodal logistics networks, meeting the stringent requirements of clinical trial sample chains, biobank redistribution, and diagnostic specimen transit under ISO 20387 and CLIA-compliant workflows.

Key Features

• Cryogenically stabilized transport platform certified to UN 3373 and IATA Packing Instruction 650 for Category B biological substances
• Proprietary LN₂-absorbing matrix providing zero-free-liquid containment, eliminating spill risk during handling, tilt, or vibration
• Validated hold times of 8, 13, or 21 days at ≤ −150 °C—verified per ASTM F2626-22 (Standard Test Method for Hold Time of Cryogenic Shippers)
• Lockable, tamper-evident lid with integrated internal isolation chamber and secondary containment barrier
• Lightweight aerospace-grade aluminum housing with ergonomic lift-handle design compatible with standard airline cargo pallets and courier trolleys
• Modular internal configuration supporting variable payload geometries—including bone marrow units, cardiac valves, and large-format tissue constructs

Sample Compatibility & Compliance

The Arctic Express accommodates a broad range of primary and secondary containers, including 1.2 mL, 1.5 mL, 2.0 mL, and 1 mL cryovials (e.g., AY509X12, AY509X13, AY509X32, AY509X33), as well as Cryosleeve™ sleeves (AY509X21) and Cryocane™ storage systems (4000211). BioCane™ carriers (AY509X9, AY509X1) integrate seamlessly with the system’s internal cryo-tank assembly, enabling secure stacking and orientation control. All configurations comply with FDA 21 CFR Part 11 data integrity expectations when used in conjunction with validated electronic shipping logs, and support GLP/GMP audit trails through documented cold chain validation reports. The system meets ISO/IEC 17025 calibration traceability requirements for temperature monitoring devices deployed within its thermal envelope.

Software & Data Management

While the Arctic Express is a passive transport system, it is fully compatible with Thermo Fisher’s Traceable™ Wireless Temperature Monitoring Platform (sold separately). Integrated Bluetooth-enabled loggers—deployed inside the unit prior to loading—record time-stamped temperature profiles at user-defined intervals (1–60 min), generating encrypted PDF reports compliant with 21 CFR Part 11 Annex 11 and EU GDP guidelines. Data export supports CSV, PDF, and XML formats; cloud synchronization enables real-time remote monitoring via Thermo Fisher’s SampleManager™ LIMS interface. Validation documentation packages—including IQ/OQ protocols, uncertainty budgets, and thermal mapping reports—are available upon request for regulatory submission readiness.

Applications

• Clinical trial biospecimen transport between central labs, sites, and biorepositories
• Shipping of hematopoietic stem cells, CAR-T products, and other advanced therapy medicinal products (ATMPs)
• Distribution of reference standards and proficiency testing materials requiring ultra-low temperature integrity
• Inter-facility transfer of archived tissue sections, frozen pathology blocks, and microbiological isolates
• Regulatory submissions requiring documented cold chain continuity from collection to analysis (e.g., FDA IND/IDE, EMA CTA)

FAQ

Is the Arctic Express system approved for air transport under IATA regulations?
Yes—the system is fully certified under IATA Packing Instruction 650 and carries UN 3373 classification for Category B biological substances.
What validation documentation is provided with each unit?
Each shipment includes a Certificate of Conformance, thermal mapping report summary, and hold-time validation certificate aligned with ASTM F2626-22.
Can the system be reused, and what is its service life expectancy?
The aluminum chassis and absorbent core are designed for ≥100 transport cycles when maintained per Thermo Fisher’s cleaning and inspection protocol (documented in SOP-CRYO-007).
Does the system require pre-conditioning before use?
Yes—units must undergo a standardized 24-hour pre-chill cycle using liquid nitrogen prior to first use and after extended ambient storage.
Are custom internal configurations available for non-standard sample formats?
Yes—custom foam inserts, cryo-racks (e.g., 195555 for BioCane 47), and dual-compartment layouts can be ordered under Thermo Fisher’s Engineering Services Program (ESP-ARCTIC).