VIA capsule Cryogenic Transport Container (Liquid Nitrogen-Free, -120°C Capable)
| Brand | Cytiva |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | VIA capsule |
| Pricing | Available Upon Request |
Overview
The VIA capsule is a purpose-engineered, liquid nitrogen-free cryogenic transport container designed specifically for the secure, compliant, and traceable logistics of advanced therapy medicinal products (ATMPs), including autologous and allogeneic cell therapies, viral vectors, and engineered tissues. Unlike conventional dry vapor shippers or liquid nitrogen dewars, the VIA capsule employs an integrated Stirling-cycle electric cryocooler to achieve and maintain a stable storage temperature of ≤ –120°C — a critical threshold for preserving genomic integrity, membrane stability, and functional viability of sensitive biologics during transit. Its thermally optimized architecture centers on a proprietary “thermal core” — a high-density phase-change material (PCM) module charged via active cooling prior to dispatch. Once disconnected from power, this core sustains ultra-low temperatures passively for up to 120 hours (5 days), eliminating reliance on hazardous cryogens while meeting stringent IATA PI 650 and IMDG Class 9 transport requirements for temperature-sensitive biologicals.
Key Features
- Stirling-based Active Cooling System: Integrated high-efficiency Stirling cryocooler enables pre-conditioning to ≤ –120°C prior to shipment; operates continuously when connected to AC power, supporting use as a short-term staging unit in cleanroom or GMP environments.
- Passive Thermal Core Technology: Proprietary PCM-based thermal reservoir maintains ≤ –120°C for ≥120 hours post-power-disconnect — validated under worst-case ambient conditions (40°C, 80% RH) per ISO 13485-aligned thermal mapping protocols.
- Ergonomic & Regulatory-Ready Design: Wide-mouth internal chamber (≥150 mm diameter) accommodates standard cryobags (up to 250 mL), cryoboxes, and multi-compartment cassettes; recessed base with dual-locking telescoping casters ensures stability during handling and compliance with OSHA-recommended load-movement safety standards.
- Real-Time Telemetric Monitoring: Onboard sensor suite records temperature (±0.25°C accuracy), GPS position, door-open events, and battery/cooling status; data streams encrypted via LTE-M to Chronicle™ cloud platform with configurable alert thresholds and audit-ready export (CSV/JSON).
- Intuitive Human Interface: Backlit LCD display shows real-time internal temperature, remaining passive hold time, battery level, and system health status; menu navigation supports multilingual UI (English, German, Japanese, Mandarin) without firmware update.
Sample Compatibility & Compliance
The VIA capsule is validated for transport of cryopreserved human cells (e.g., CAR-T, NK, MSC), AAV/LV vectors, oocytes, and tissue-engineered constructs stored in vapor-phase compatible containers. It conforms to ISO 14644-1 Class 5 (ISO Class 5) cleanroom-compatible materials (non-shedding interior, USP Class VI elastomers), and meets FDA 21 CFR Part 11 requirements for electronic records and signatures when used with Chronicle™ software. Full validation documentation — including IQ/OQ/PQ protocols, thermal mapping reports (per ASTM F2626-22), and cybersecurity assessment (IEC 62304 Class B) — is provided with each unit and updated annually per Cytiva’s Quality Management System (certified to ISO 13485:2016).
Software & Data Management
Chronicle™ is a secure, browser-accessible SaaS platform enabling end-to-end chain-of-custody visibility for ATMP shipments. It supports role-based access control (RBAC), automated deviation logging, and integration with LIMS (via HL7/FHIR APIs) and ERP systems (SAP, Oracle). All telemetry data is timestamped, digitally signed, and retained for ≥36 months to satisfy EU Annex 11, FDA 21 CFR Part 11, and MHRA GxP data integrity expectations. Audit trails include user login history, parameter changes, and alarm acknowledgments — all exportable in PDF/A-2b format for regulatory inspection readiness.
Applications
- Point-of-care delivery of personalized cell therapies between manufacturing sites and treatment centers
- Multi-site clinical trial logistics requiring consistent –120°C exposure across geographically dispersed sites
- GMP-compliant staging of cryopreserved batches prior to final release testing
- Backup cold storage during LN2 supply chain disruption or facility maintenance
- Transport of reference standards and calibration materials for QC labs operating under ISO/IEC 17025
FAQ
Does the VIA capsule require liquid nitrogen or dry ice?
No — it is fully liquid nitrogen-free and does not utilize dry ice, compressed gases, or phase-change gel packs.
Can it be used for long-term storage beyond 5 days?
It is intended for transport and short-term staging (≤72 hours under power); extended storage requires connection to continuous AC power and validation against site-specific SOPs.
Is Chronicle™ software included with purchase?
Yes — each VIA capsule ships with a perpetual license for Chronicle™ Cloud, including firmware updates and technical support for the device’s operational lifetime.
What happens if the thermal core reaches its hold-time limit?
The system triggers audible/visual alarms 24 hours before predicted temperature excursion and transmits an urgent notification via Chronicle™ with GPS-tagged location and historical trend data.
How is cybersecurity managed for remote monitoring?
All communications use TLS 1.2+ encryption; device authentication employs X.509 certificates; Chronicle™ infrastructure is hosted in SOC 2 Type II–compliant AWS GovCloud (US) regions.
