AZENTA BioStore™ Cryogenic Storage System (-190°C)

Overview

The AZENTA BioStore™ Cryogenic Storage System (-190°C) is an automated, vapor-phase liquid nitrogen (LN₂) based biorepository platform engineered for long-term, ultra-stable preservation of sensitive biological specimens—including primary cells, stem cells, embryos, oocytes, tissue sections, and nucleic acid extracts. Unlike conventional manual dewars or mechanical ultra-low temperature (ULT) freezers, the BioStore™ system maintains a consistent, uniform -190°C environment across its entire storage volume using precisely regulated LN₂ vapor phase delivery—eliminating direct contact between samples and liquid phase nitrogen while preventing thermal shock, cross-contamination, and ice crystal formation. Its architecture integrates robotic sample handling, real-time environmental monitoring, and fail-safe thermal retention to meet stringent requirements for biobanking, clinical trial sample management, and GCP-compliant translational research workflows.

Key Features

• Vapor-phase LN₂ cooling with stable, uniform -190°C operating temperature across all storage zones
• Automated robotic arm with sub-millimeter positioning accuracy for rapid sample retrieval (≤60 seconds per tube)
• Scalable modular design supporting up to 63,000 × 2 mL cryovials or 123,480 × 1 mL vials in standard SBS-format racks and cryoboxes
• Multi-format compatibility: accommodates cryoboxes (10×10, 8×12), blood bags, cryo-straws, and custom cryogenic containers
• Passive thermal holdover: maintains < -135°C for ≥20 days during complete LN₂ supply interruption or power loss
• Manual override mode enables emergency sample access without automation dependency
• Redundant environmental sensors (temperature, LN₂ level, O₂ concentration, door status) with configurable alarm thresholds and remote notification

Sample Compatibility & Compliance

The BioStore™ system supports ISO/IEC 17025-aligned sample integrity protocols and is validated for use in environments governed by CAP, CLIA, and FDA 21 CFR Part 11 requirements. It complies with ASTM F2647–21 (Standard Practice for Biobanking of Human Biospecimens) and supports GLP/GMP audit trails through timestamped, user-authenticated log entries for every storage/retrieval event. All internal surfaces are constructed from electropolished stainless steel (316L) with seamless welds to ensure cleanability and minimize condensate accumulation. Sample containers adhere to ANSI/SLAS standards for footprint and barcode placement, enabling full traceability via 2D DataMatrix scanning integrated into the robotic workflow.

Software & Data Management

The BioStore™ Control Suite is a secure, role-based web application built on a PostgreSQL backend with TLS 1.3 encryption and LDAP/Active Directory integration. It provides real-time inventory visualization, dynamic rack mapping, automated QC flagging (e.g., temperature excursions, overdue maintenance), and exportable audit logs compliant with ALCOA+ principles. The software supports electronic signatures, version-controlled SOP attachment, and configurable reporting templates aligned with ISO 20387:2018 (Biobanking — General requirements for biobanking). Integration with LIMS platforms (e.g., LabVantage, STARLIMS, Thermo Fisher SampleManager) is achieved via RESTful APIs and HL7/FHIR-compliant messaging.

Applications

• Large-scale biobanks requiring ISO 20387-certified infrastructure
• Clinical trial sample repositories managing longitudinal cohorts under ICH-GCP
• Cell therapy manufacturing facilities storing cryopreserved CAR-T and MSC products
• Academic core facilities supporting high-throughput genomics and single-cell sequencing pipelines
• Pharmaceutical R&D labs archiving reference standards, stability panels, and potency assay materials
• Federal and international biospecimen networks requiring chain-of-custody documentation and disaster recovery capability

FAQ

What is the difference between vapor-phase and liquid-phase LN₂ storage?
Vapor-phase storage maintains samples above the liquid nitrogen surface, eliminating direct immersion and associated risks of cross-contamination, vial explosion, and thermal stress during retrieval.
Does the system require external LN₂ refilling?
Yes—the BioStore™ operates with continuous or scheduled LN₂ replenishment via integrated auto-fill interface; optional LN₂ monitoring and predictive consumption analytics are available.
Can the system be integrated into an existing facility BMS?
Yes—via Modbus TCP or BACnet/IP protocols for HVAC, fire suppression, and environmental alarm synchronization.
Is validation support provided for IQ/OQ/PQ documentation?
AZENTA offers factory-verified qualification packages including protocol templates, test scripts, and witnessed execution reports for regulatory submissions.
What happens if network connectivity is lost?
Local control remains fully functional; all operations, logging, and environmental monitoring continue autonomously with synchronized data upload upon restoration.