Traceable® Tac Digital Temperature Data Logger

Overview

The Traceable® Tac Digital Temperature Data Logger (Model VWRI620-2635) is a precision-engineered, stand-alone temperature monitoring instrument designed for continuous, high-fidelity thermal validation in regulated and research-critical environments. Built upon a platinum resistance thermometer (RTD) sensing architecture compliant with IEC 60751 Class A tolerances, it delivers stable, drift-resistant measurements across an extended operational range of –200.00 °C to +105.00 °C—enabling reliable tracking of cryogenic storage, ultra-low freezers, incubators, stability chambers, and transport logistics. Its core functionality centers on autonomous, time-stamped data acquisition with user-configurable logging intervals (from 1 second to 24 hours), eliminating dependency on external software or host systems during operation. The device meets the foundational requirements for temperature monitoring under ISO 17025-accredited calibration practices and supports traceability to NIST via factory-applied multi-point calibration certificates.

Key Features

• Platinum RTD sensor with 316 stainless steel probe sheath and 1-meter PTFE-insulated cable—optimized for chemical resistance, mechanical durability, and rapid thermal response in humid or corrosive settings.
• Latching visual/audible alarm system: triggers upon deviation beyond user-defined high/low thresholds and remains active until manually acknowledged—even after temperature returns to acceptable limits—ensuring no excursion event goes unobserved.
• Onboard memory stores up to 525,600 timestamped readings (equivalent to one year of data at 1-minute intervals), preserving integrity without battery-backed volatile memory.
• USB mass-storage-class interface enables direct drag-and-drop export of comma-separated value (CSV) files to Windows, macOS, or Linux systems—no proprietary drivers or installation required.
• Excursion-Trac™ firmware feature automatically flags and timestamps all out-of-specification events, generating dedicated summary rows in exported logs for rapid QA/QC review.
• Operational continuity: data download and analysis occur without interrupting live logging—critical for uninterrupted cold chain verification during shipment handoffs or chamber qualification runs.

Sample Compatibility & Compliance

The VWRI620-2635 is validated for direct immersion, surface contact, and air monitoring applications across pharmaceutical, biotech, clinical laboratory, and food safety workflows. Its sensor geometry and thermal mass support accurate measurement in liquid nitrogen vapor phase (–196 °C), ultra-low temperature freezers (–80 °C), water baths, and ambient storage areas. The device complies with essential elements of FDA 21 CFR Part 11 for electronic records when deployed with documented SOPs governing alarm acknowledgment, data export, and audit trail review. It supports GLP/GMP-aligned validation protocols including IQ/OQ documentation templates and satisfies key clauses of ISO 13485:2016 (clause 7.5.10) and EU Annex 15 (Validation of Qualification). Factory calibration includes certified reference points at –196 °C (liquid nitrogen), –80 °C (dry ice/ethanol), 0 °C (ice point), and 100 °C (boiling water), each traceable to NIST SRM standards with documented uncertainties.

Software & Data Management

No dedicated software is required for basic operation or data retrieval; however, exported CSV files are fully compatible with industry-standard analysis platforms including Microsoft Excel, JMP, Python (pandas/matplotlib), and validated LIMS or ELN systems. Each log file contains columns for date/time (ISO 8601 format), measured temperature (°C), status flag (OK/ALERT), and Excursion-Trac™ event markers. Timestamps are generated by an internal real-time clock (RTC) with ±2 seconds/month accuracy and retain validity across power cycles. For regulated environments, users may implement supplementary controls—such as digital signature workflows, version-controlled export directories, and periodic backup verification—to satisfy ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).

Applications

• Monitoring thermal stability of mRNA vaccines, monoclonal antibodies, and other thermolabile biologics during frozen storage and distribution.
• Mapping temperature uniformity and recovery profiles in pharmaceutical stability chambers per ICH Q5C guidelines.
• Validating cold chain integrity for clinical trial sample shipments (e.g., PBMCs, tissue biopsies) under WHO TRS 961 Annex 9 requirements.
• Supporting ISO/IEC 17025 accredited calibration labs in documenting probe performance over extended exposure cycles.
• Long-term environmental trending in cleanrooms, server rooms, and archival vaults where passive logging must coexist with active HVAC monitoring.

FAQ

Is the VWRI620-2635 suitable for use in liquid nitrogen?
Yes—the platinum RTD sensor and 316 stainless steel probe are rated for intermittent immersion in liquid nitrogen vapor phase (–196 °C); direct full immersion is not recommended due to thermal shock risk.

Can alarm thresholds be modified in the field?
Yes—thresholds, hysteresis, and alarm duration are configurable via intuitive button navigation; changes are saved non-volatilely and require no PC connection.

Does the device meet FDA 21 CFR Part 11 requirements out-of-the-box?
No—compliance depends on procedural controls (e.g., user authentication, audit trail retention, electronic signature implementation); the hardware provides the foundational capabilities required for such configurations.

How is calibration traceability documented?
Each unit ships with a Traceable® Certificate of Calibration listing actual measured deviations at four NIST-traceable temperatures, uncertainty budgets, and technician signatures—valid for 12 months from date of issue.

What is the battery life under typical logging conditions?
With default 1-minute intervals and no alarm activation, the CR2032 coin cell provides ≥12 months of continuous operation; low-battery indicators appear 30 days prior to end-of-life.