Azenta SampleStore™ SE Automated Sample Storage System (Room Temperature to -20°C)

Overview

The Azenta SampleStore™ SE Automated Sample Storage System is an engineered solution for reliable, high-integrity sample archiving and retrieval across a temperature range of +20°C to –20°C. Designed specifically for mid-throughput biopharmaceutical laboratories, clinical research units, and translational science facilities, the system implements a modular robotic carousel architecture with precision stepper-motor-driven gripper mechanisms and integrated environmental control. Unlike ultra-low-temperature cryogenic systems (–80°C or liquid nitrogen), the SampleStore™ SE operates within a thermally stabilized refrigerated envelope—enabling consistent thermal homogeneity (±0.5°C setpoint stability) while minimizing energy consumption and mechanical stress on plastic consumables. Its core function is the automated handling, barcoded tracking, and audit-compliant storage of primary and secondary sample containers—including 96-well plates, 2D matrix tubes (1.0–2.0 mL), cryovials (0.5–5.0 mL), and custom rack formats—without manual intervention.

Key Features

• Temperature-Controlled Environment: Dual-zone refrigeration system maintains uniform setpoints from +20°C (ambient lab) to –20°C with independent sensor feedback loops and redundant thermal monitoring.
• Robust Automation Architecture: High-repeatability robotic arm with ISO Class 5 (Class 100) compatible motion control; cycle time ≤ 8.2 seconds per tube retrieval under standard load conditions.
• High-Density Scalable Storage: Modular rack design supports up to 40,000 samples in a footprint of 1.2 m × 0.8 m (47″ × 31″); expandable via additional carousel modules without software reconfiguration.
• Barcode-Driven Sample Integrity: Integrated 2D barcode reader (ISO/IEC 15415 compliant) verifies tube, rack, and position identity at every handling step; automatic mismatch flagging prevents misplacement.
• Fail-Safe Environmental Monitoring: Real-time logging of temperature, humidity, door status, and system power with local SD card backup and optional cloud sync; alarm thresholds configurable per ICH M7 and FDA 21 CFR Part 11 Annex 11 guidelines.

Sample Compatibility & Compliance

The SampleStore™ SE accommodates industry-standard consumables including ANSI/SLAS-format racks, Matrix™-compatible tubes, Thermo Scientific™ Nunc™ cryovials, and Corning® 96-well plates. All internal surfaces are constructed from electropolished stainless steel (ASTM A967 passivated) and food-grade polymer composites resistant to ethanol, isopropanol, and common decontamination agents. The system complies with IEC 61000-6-2 (EMC immunity), UL 61010-1 (laboratory equipment safety), and meets essential requirements of EU Machinery Directive 2006/42/EC. Full traceability logs—including operator ID, timestamp, action type (store/retrieve/audit), and environmental metadata—are retained for ≥10 years, supporting GLP, GCP, and GMP-aligned workflows.

Software & Data Management

Control and monitoring are managed through Azenta’s SampleStore™ Control Suite v4.x—a Windows-based application validated per IQ/OQ protocols and compliant with 21 CFR Part 11 requirements (electronic signatures, audit trail, role-based access control). The software enables batch scheduling, inventory forecasting, QC sample reservation, and integration with LIMS platforms via HL7 v2.5 or RESTful API. All data transactions are encrypted using AES-256; audit trails are immutable and exportable in CSV or PDF format for regulatory submission. Optional validation packages include full URS documentation, risk assessment (FMEA), and installation/commissioning reports aligned with ISO/IEC 17025 laboratory accreditation criteria.

Applications

• Biobanking of clinical trial biospecimens (serum, plasma, PBMCs) requiring stable –20°C preservation prior to downstream omics analysis.
• Compound library management in early-stage drug discovery, where repeated freeze-thaw cycles must be minimized for small-molecule integrity.
• QC sample archiving in biomanufacturing environments, supporting lot release testing and stability studies per ICH Q5C.
• Automated sample staging for high-throughput screening (HTS) workflows interfaced with liquid handlers and plate readers.
• Regulatory archive retention for FDA IND/BLA submissions, ensuring chain-of-custody continuity from collection to analytical testing.

FAQ

What temperature uniformity can be expected across the storage chamber?
The system achieves ±0.5°C uniformity at all rack positions when operating at –20°C, verified by 12-point NIST-traceable thermocouple mapping during factory qualification.
Is remote monitoring supported?
Yes—via secure HTTPS web interface with TLS 1.2 encryption; real-time alerts delivered via SMTP or SNMP trap to designated IT infrastructure.
Can the system integrate with existing LIMS without custom development?
Standard HL7 v2.5 messaging is preconfigured; API documentation and Postman collections are included with software license.
What maintenance intervals are recommended?
Preventive maintenance is scheduled annually; calibration of temperature sensors and robotic positioning accuracy is performed per ISO/IEC 17025 traceable procedures.
Does the system support dual-operator authentication for critical actions?
Yes—“two-person rule” mode is enabled in administrator settings for sample deletion, system configuration changes, and audit trail purging.