Traceable® Tac Digital Temperature Data Logger for Refrigerators and Freezers

Overview

The Traceable® Tac Digital Temperature Data Logger (Model 94460-07) is a purpose-built, FDA-aligned monitoring solution engineered for continuous, high-fidelity temperature surveillance in cold-chain critical environments—including pharmaceutical refrigerators, vaccine storage units, biomedical freezers, and laboratory cold rooms. Utilizing a patented bottle-style probe filled with thermal mass-equilibrating fluid, the device replicates the thermal response profile of liquid-filled vials or syringes—ensuring measurement fidelity aligned with CDC’s Vaccine Storage and Handling Toolkit and USP <1079> requirements. Its core architecture integrates a high-stability NTC thermistor (calibrated against NIST-traceable standards), low-power microcontroller, non-volatile memory, and dual-mode visual/audible alarm circuitry—all housed in an IP54-rated enclosure designed for condensation-prone environments. Unlike generic thermometers, the Tac logger captures time-synchronized, audit-ready temperature history without requiring host software or network infrastructure—making it suitable for GLP-compliant labs, GMP-regulated QC areas, and decentralized clinical sites.

Key Features

• Patented glycol-equilibrated bottle probe ensures thermal lag matching real-world vaccine and reagent containers—critical for compliance with CDC and Joint Commission cold-chain validation protocols.
• Configurable logging intervals from 1 second to 24 hours via intuitive front-panel interface; no PC required for setup or operation.
• Real-time LCD display shows current, min, and max temperatures simultaneously—with user-selectable °C/°F units and battery status indicator.
• Non-volatile memory retains up to 525,600 timestamped readings (equivalent to one reading per minute for one year), structured in rolling-buffer architecture.
• Dual-stage alarm system: visual (flashing LED) and audible (85 dB buzzer); alarms persist until manually acknowledged—even after temperature returns to acceptable range.
• USB-A port enables direct CSV export to any Windows PC or macOS system using standard USB flash drives—no proprietary drivers or cloud dependencies.
• Operational continuity during data retrieval: logging continues uninterrupted while data is being downloaded—a key requirement for 24/7 monitored environments.
• Multi-mounting kit included (magnetic strip, Velcro® fasteners, wall bracket, and adhesive base) for rapid deployment across diverse cabinet types and door configurations.

Sample Compatibility & Compliance

The 94460-07 is validated for use with aqueous, glycol-based, and vaccine-filled containers (e.g., 5 mL vials). Its bottle probe design conforms to CDC-recommended “simulated product” monitoring methodology, where sensor placement mimics actual stored material rather than ambient air. The unit meets ISO/IEC 17025 calibration traceability requirements through its included Traceable® Certificate—documenting as-found/as-left data, uncertainty budgets, and NIST-traceable reference standards used. It supports adherence to FDA 21 CFR Part 11 when paired with controlled CSV handling procedures (e.g., file integrity checksums, operator log entries). While not intrinsically rated for hazardous locations, its stainless-steel probe variants (e.g., 94460-09, 94460-17) comply with ASTM E2810 for stability testing of refrigerated transport systems.

Software & Data Management

No dedicated software installation is required. Raw temperature logs export as plain-text CSV files containing columns for timestamp (YYYY-MM-DD HH:MM:SS), temperature (°C), and alarm flag (TRUE/FALSE). Each file includes embedded metadata: model number, serial ID, calibration date, and user-defined site/location tag. For regulated environments, laboratories may integrate these CSV outputs into LIMS or ELN platforms via automated ingestion scripts. Audit trails are preserved via immutable file timestamps and manual annotation fields within the CSV header. Optional companion tools—such as Traceable® LogView (freeware) —provide basic graphing, statistical summaries (mean, SD, excursions), and PDF report generation compatible with internal QA reviews.

Applications

• Vaccine storage monitoring per CDC and ACIP guidelines in pharmacies, clinics, and public health departments.
• Stability chamber qualification and routine monitoring under ICH Q5C and USP <1151>.
• Biobank freezer validation (−20 °C, −80 °C) using compatible ultra-low variants (e.g., 98768-53/54).
• Transport validation studies for cold-chain logistics (e.g., shipping containers, courier coolers).
• QC/QA documentation for ISO 13485-certified medical device manufacturers storing temperature-sensitive components.
• Academic and clinical research labs maintaining cryopreserved cell lines, serum samples, or RNA/DNA stocks.

FAQ

Does the 94460-07 require annual recalibration?
Yes—Avantor recommends annual recalibration against NIST-traceable references to maintain compliance with ISO/IEC 17025 and internal quality system requirements. The included Traceable® Certificate documents initial calibration but does not constitute ongoing metrological assurance.
Can multiple loggers be synchronized to a common time source?
No—the device lacks network connectivity or GPS synchronization. Time is set manually and drift is less than ±1 minute per month at 25 °C, which meets CDC’s ±2-minute tolerance for vaccine monitoring records.
Is the USB data transfer function validated for 21 CFR Part 11 compliance?
The hardware itself is not Part 11–certified, but CSV export supports implementation of compliant workflows when combined with procedural controls (e.g., electronic signatures for download authorization, version-controlled file naming, and secure archival in validated document management systems).
What is the expected battery life under typical use?
With default 1-minute logging interval and no active alarms, the included CR2032 coin cell provides ≥12 months of continuous operation. Low-battery warnings appear on the LCD 72 hours prior to functional depletion.
Are replacement probes available separately?
Yes—Avantor supplies all probe variants (bottle, bullet, stainless steel, glycol-filled plastic) as field-replaceable components under distinct VWRI620-xxxx catalog numbers, enabling modular maintenance without full-unit replacement.