BioLife Solutions BioT ULT Mobile Workstation

Overview

The BioLife Solutions BioT ULT Mobile Workstation is an engineered ultra-low temperature (ULT) stability platform designed for field-deployable, on-site processing and transport of cryopreserved biological specimens—including primary cells, stem cells, PBMCs, tissue biopsies, and clinical trial biosamples. Unlike conventional portable freezers or passive shippers, the BioT integrates active thermal management with a patent-pending Dry Ice-Integrated Rapid Thermal Management (DIRTM) cooling insert system. This architecture enables precise, reproducible maintenance of temperatures between −75°C and −50°C without external power during operation—critical for preserving sample integrity during transient handling outside controlled laboratory environments. The workstation operates in dual modes: powered temperature control (−50°C to +70°C) for ambient or refrigerated workflows, and dry ice–driven ULT mode for short-term cryogenic manipulation where −80°C freezer access is unavailable.

Key Features

• Patent-pending DIRTM cooling insert technology ensures full immersion of samples in a stable sub-−50°C thermal zone up to 10 inches (25.4 cm) deep from chamber top
• Dual-mode operation: electrically powered precision temperature control (±0.1°C accuracy, ±1°C uniformity) and dry ice–based ULT mode (−75°C to −50°C)
• Rapid thermal equilibration: achieves <−50°C throughout the effective working zone within 30 minutes using ≤3 kg dry ice
• Extended hold time: maintains <−50°C for >15 hours with lid open—validated under ISO 13485–aligned environmental testing protocols
• Compact mobile form factor (152.4 × 71.1 × 44.5 cm) with integrated casters and ergonomic handle for intra-facility transport
• Low-power consumption (1 kW) compatible with standard 120 V/60 Hz outlets; no dedicated circuit required
• Stainless steel interior chamber with non-porous, cleanroom-compatible surface finish (Ra < 0.8 µm)

Sample Compatibility & Compliance

The BioT ULT Workstation supports vial formats ranging from 0.5 mL cryotubes to 2.0 mL internally threaded tubes, 96-well plates (with optional rack adapters), and cryoboxes up to 10 × 10 configuration. It accommodates standard ANSI/SLAS footprint dimensions and integrates seamlessly into existing biobanking SOPs. All thermal performance data are generated per ASTM E2294 (Standard Practice for Performance Verification of Ultra-Low Temperature Freezers) and validated against USP <1046> “Cryopreservation of Cells, Tissues, and Organs.” The device complies with IEC 61000-6-3 (EMC emissions) and IEC 61010-1 (safety requirements for lab equipment). For regulated environments, audit trails, user access logs, and temperature deviation alerts can be exported in CSV format compliant with FDA 21 CFR Part 11 requirements when paired with BioLife’s optional CloudConnect™ telemetry module.

Software & Data Management

While the BioT ULT Workstation operates as a standalone hardware platform, its digital interface supports optional integration with BioLife Solutions’ BioTrack™ CloudConnect™ software suite. This secure, web-based application provides real-time remote monitoring of chamber temperature (multiple probe locations), dry ice depletion estimation, session duration tracking, and event logging—including door-open intervals, thermal excursions, and operator ID entry. All data are stored in encrypted AWS-hosted infrastructure meeting HIPAA and GDPR standards. Exported reports include timestamps, probe IDs, and calibrated temperature values traceable to NIST standards. No local database installation is required; all firmware updates are delivered over-the-air via TLS 1.2–secured connections.

Applications

• Cherry-picking and reformatting of cryopreserved samples directly at point-of-collection—eliminating repeated freeze-thaw cycles associated with transport to centralized −80°C facilities
• Controlled transfer of frozen specimens between cleanrooms, BSL-2 labs, and automated biorepositories while maintaining continuous chain-of-cold integrity
• Pre-shipment preparation: labeling, barcoding, secondary packaging, and documentation under validated ULT conditions to prevent thermal drift prior to dry shipper loading
• On-site cell therapy manufacturing support—enabling cryo-manipulation steps (e.g., DMSO removal, wash steps, formulation) within GMP-aligned mobile clean booths
• Field-based clinical trial sample stabilization: immediate post-collection freezing and short-term holding prior to courier dispatch, aligned with ISBER Best Practices and CAP accreditation guidelines

FAQ

What is the maximum recommended dry ice load for optimal performance?
The BioT ULT Workstation is optimized for 2.5–3.0 kg of pelletized dry ice. Exceeding 3.5 kg does not extend hold time and may impede airflow across the DIRTM insert.
Can the unit maintain −80°C?
No. The BioT ULT Workstation is engineered for stable operation between −75°C and −50°C in dry ice mode. It is not designed to reach or sustain −80°C, which requires mechanical cascade refrigeration.
Is validation documentation available for GxP environments?
Yes. IQ/OQ documentation templates, calibration certificates (NIST-traceable), and thermal mapping reports per ISO 14644-3 are provided upon request for qualified purchasers.
Does the workstation require routine maintenance?
No scheduled maintenance is required. Routine cleaning with 70% isopropyl alcohol and visual inspection of gasket integrity every 6 months is recommended per manufacturer guidelines.
Can third-party temperature loggers be installed inside the chamber?
Yes. The chamber includes two pre-drilled 6 mm access ports with silicone grommets, enabling insertion of external probes without compromising thermal seal integrity.