VOYAGEUR2 Dry Shipper for Biological Sample Transport

Overview

The VOYAGEUR2 Dry Shipper is an engineered cryogenic transport solution designed for the safe, reliable, and compliant transit of temperature-sensitive biological specimens—including human embryos, oocytes, stem cells, cord blood units, and primary cell lines—at ultra-low temperatures (–150 °C to –190 °C) without liquid-phase nitrogen exposure. Unlike conventional liquid nitrogen dewars, the VOYAGEUR2 employs a proprietary porous adsorbent matrix that fully absorbs and immobilizes liquid nitrogen, converting it into a stable, high-density vapor phase environment. This “dry vapor” architecture eliminates risks associated with sloshing, spillage, or direct contact with cryogenic liquids during road, rail, or air transport—ensuring both operator safety and sample integrity under dynamic conditions. Its thermal performance is validated per ISO 23556:2021 (Biological sample transport containers) and meets stringent regulatory requirements for hazardous goods transportation under ADR (road), IATA-DGR (air), and RID (rail) frameworks.

Key Features

• Patented dry-phase LN₂ retention system using high-capacity porous ceramic absorbent material, enabling zero free-liquid transport
• Thermally optimized vacuum-insulated stainless steel construction with multi-layer reflective shielding for minimal heat ingress
• Integrated T-Tracker data logger: records continuous temperature profiles (–196 °C to +50 °C) with ±0.5 °C accuracy, timestamped at user-configurable intervals (1–60 min)
• USB-retrievable audit trail compliant with FDA 21 CFR Part 11 (when used with validated software), supporting GLP/GMP traceability requirements
• Modular internal geometry accommodating standard cryogenic accessories: aluminum canes, labeled storage racks, and ISO-compliant cryoboxes
• Low daily evaporation rate (0.1 L/day) ensures ≥8 days of dynamic holding time under ambient conditions (25 °C, 60% RH)

Sample Compatibility & Compliance

The VOYAGEUR2 supports diverse biospecimen formats including 0.25 mL and 0.5 mL straws, 2 mL external-thread vials (mounted on aluminum rods or in 100-vial boxes), and 5 mL vials. Its internal dimensions (30 mm neck ID, 120 mm cane depth) are compatible with major IVF and biobanking workflows. The unit is certified for international shipment of Category B biological substances (UN3373) and complies with Annex A of IATA Dangerous Goods Regulations, Chapter 6.2 of ADR, and RID Annex 2. All materials contacting cold surfaces meet USP Class VI biocompatibility standards; no leachables or extractables have been detected in validated elution studies.

Software & Data Management

The T-Tracker logger interfaces via USB 2.0 with Windows-based desktop software (v4.2+), enabling secure download, visualization, and export of time-stamped temperature logs in CSV and PDF formats. Audit trail functionality includes electronic signatures, user access controls, and immutable event logging—fully aligned with ALCOA+ principles. Raw data files include metadata headers (device ID, calibration date, operator ID, start/stop timestamps), facilitating integration into LIMS or electronic lab notebook (ELN) platforms. Firmware updates and configuration changes require dual-authentication, satisfying FDA 21 CFR Part 11 electronic record requirements when deployed in regulated environments.

Applications

• Clinical embryology labs transporting gametes and embryos between IVF centers and fertility clinics
• Biobanks distributing reference cell lines or rare disease samples under ISO 20387-accredited conditions
• Pharmaceutical R&D sites shipping clinical trial biospecimens for central lab analysis
• Academic core facilities managing inter-institutional exchange of CRISPR-edited stem cell lines
• Regulatory submissions requiring documented cold chain continuity from collection to analysis

FAQ

What is the maximum allowable ambient temperature for maintaining ≥8-day holding time?
The specified 8-day dynamic holding time is validated at 25 °C and 60% relative humidity. Performance degrades linearly above 30 °C; consult the thermal validation report for derating curves.
Can the VOYAGEUR2 be refilled mid-transport?
No. It is a single-fill, maintenance-free system. Refilling compromises vacuum integrity and voids compliance certifications.
Is the T-Tracker data logger calibrated traceable to NIST standards?
Yes. Each unit ships with a certificate of calibration traceable to NIST SRM 1750a (Cryogenic Temperature Standard), valid for 12 months from date of issue.
Does the VOYAGEUR2 support automated inventory tracking via RFID?
Not natively. However, its standardized internal dimensions accommodate third-party RFID-enabled cane holders and rack systems compliant with ISO/IEC 18000-3 Mode 1.
How is leak integrity verified prior to shipment?
Each unit undergoes helium mass spectrometry leak testing (<1×10⁻⁹ mbar·L/s) during final QA. A serialized test report is included with every shipment.