Traceable® Ultra Refrigerator/Freezer Thermometer Model 98767-54

Overview

The Traceable® Ultra Refrigerator/Freezer Thermometer (Model 98767-54) is a purpose-engineered, NIST-traceable temperature monitoring instrument designed for continuous, reliable surveillance of cold-chain storage environments—including pharmaceutical refrigerators, ultra-low freezers, vaccine storage units, and laboratory cold rooms. Unlike single-point digital thermometers, this device implements a glycol-filled bottle probe architecture to emulate the thermal mass and response time of biological or liquid samples—ensuring that recorded min/max values reflect actual product exposure conditions rather than ambient air fluctuations. Its core functionality is grounded in high-stability thermistor sensing, coupled with proprietary latching alarm logic that maintains alert status until manually acknowledged, even after temperature recovery. This behavior complies with critical regulatory expectations for uninterrupted event logging in GLP, GMP, and USP environments.

Key Features

• Latching Dual-Mode Alarm System: Visual (flashing LED) and audible (85 dB at 10 cm) alerts persist until user reset—eliminating missed excursions during unattended periods such as nights, weekends, or holidays.
• Triple-Simultaneous Display: Real-time current temperature, plus independently tracked minimum and maximum values—all visible on a single backlit LCD screen with °F/°C toggle capability.
• Programmable Thresholds: Alarm setpoints adjustable in 0.1°C increments across the full operating range, supporting precise compliance with storage specifications for vaccines (e.g., CDC-recommended 2–8°C), frozen plasma (−18°C or colder), or cryopreserved cell lines.
• Glycol-Filled Bottle Probe: Model 98767-54 includes a single 15 mL glycol-filled glass bottle probe, thermally buffered to match the thermal inertia of clinical or research specimens—critical for meeting USP “simulated load” requirements.
• Traceability & Documentation: Supplied with a NIST-traceable Certificate of Calibration documenting as-found/as-left data, uncertainty budgets, and environmental conditions at time of certification—fully compliant with ISO/IEC 17025 and FDA 21 CFR Part 11 audit readiness when paired with secure electronic recordkeeping.
• Flexible Installation: Integrated magnetic backing and industrial-grade Velcro® straps enable rapid, non-invasive mounting on stainless steel or painted metal surfaces; 10-foot teflon-insulated cable ensures probe placement flexibility without signal degradation.

Sample Compatibility & Compliance

This thermometer is validated for use with temperature-sensitive biologics, including mRNA vaccines, monoclonal antibodies, blood components, and cryopreserved stem cells. The glycol-filled probe design satisfies USP Annex 1 criteria for “representative thermal mass,” ensuring recorded extremes correlate with actual product stability thresholds—not air temperature artifacts. It meets ICH Q5C stability testing guidance for long-term storage condition monitoring and supports compliance with EU GDP Annex 9, WHO Technical Report Series No. 961, and Joint Commission EC.02.05.01 standards. No recalibration is required between certificate intervals unless subjected to mechanical shock or prolonged exposure beyond its specified operating range (−50°C to +70°C).

Software & Data Management

While the Model 98767-54 operates as a standalone, self-contained monitor, its logged min/max data can be manually transcribed into LIMS, ELN, or electronic temperature mapping systems. For automated integration, users may pair it with Traceable® LogMaster™ software (sold separately) via optional USB interface adapters—enabling CSV export, trend visualization, and configurable email/SMS alerts. All calibration records adhere to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) and support 21 CFR Part 11 compliance when deployed with appropriate access controls and audit trails.

Applications

• Continuous monitoring of pharmacy refrigerators storing insulin, epinephrine, or biologics
• Ultra-low temperature freezer validation (−70°C to −80°C) using external probe routing
• Vaccine cold chain verification per CDC Vaccine Storage and Handling Toolkit
• Environmental qualification of walk-in cold rooms per ISO 14644-3
• QC release testing support for temperature-controlled shipping containers
• GLP-compliant study documentation for preclinical sample storage

FAQ

Is the NIST-traceable certificate included with every unit?
Yes—each Model 98767-54 ships with a unique, factory-issued Certificate of Calibration traceable to NIST Standard Reference Materials, including measurement uncertainty, confidence level (k=2), and environmental test conditions.
Can the alarm be silenced without resetting the min/max memory?
No—the visual and audible alarms are latching by design; acknowledgment resets both alarm state and clears the latched indicator, but min/max values remain stored until power cycle or manual reset.
What is the expected battery life under continuous operation?
Typical service life exceeds 12 months with standard alkaline batteries (included); low-battery indicator activates at ≤2.4 V DC.
Does the glycol probe require periodic refilling or maintenance?
No—the sealed glycol-filled bottle probe is maintenance-free and rated for indefinite service life under normal laboratory conditions.
How does this model differ from the 98767-55 or 98767-59 variants?
Model 98767-54 includes one glycol-filled glass bottle probe; 98767-55 adds a second identical probe for dual-zone monitoring; 98767-59 features a patented vaccine-specific bottle geometry optimized for vial contact thermal coupling.