Traceable® 56000-10 Multi-Channel Temperature & Humidity Data Logger with Real-Time Clock

Overview

The Traceable® 56000-10 is a NIST-traceable, multi-channel temperature and humidity data logger engineered for continuous environmental monitoring in regulated laboratory, clinical, and cold-chain storage environments. Unlike single-parameter indicators, this device integrates high-stability capacitive humidity sensing and precision thermistor-based temperature measurement within a single compact housing—enabling simultaneous, real-time acquisition of ambient temperature, relative humidity, and synchronized time stamping. Its architecture complies with fundamental requirements for environmental validation under FDA 21 CFR Part 11 (audit trail-capable logging), ISO 14644 (cleanroom monitoring), and USP (good storage and distribution practices). The built-in real-time clock (RTC) maintains time accuracy within ±0.6 seconds per day, supporting chronological integrity of logged events without reliance on external synchronization—critical for unattended overnight or weekend monitoring in refrigerators, incubators, stability chambers, and biosafety cabinets.

Key Features

• Triple-line LCD display showing current temperature, min/max temperature, and real-time clock (AM/PM or 24-hour format) simultaneously—no mode switching required.
• High-contrast text and oversized tactile buttons ensure intuitive operation under gloved conditions or low-light environments.
• Non-volatile memory stores min/max temperature and humidity values until manually reset—retaining critical excursion data across power cycles.
• Integrated alarm system with visual status indicators: amber bar activates at ±1 °C deviation from setpoint; red flashing bar triggers upon sustained out-of-spec condition.
• Silence button temporarily mutes audible alarm while preserving event logging—essential during root cause investigation without compromising data integrity.
• Low-maintenance design featuring extended battery life (typical operation >12 months on one AAA cell) and firmware-optimized sensor drift compensation.
• Wall-mount bracket and fold-out desktop stand provide flexible installation options—suitable for vertical mounting inside refrigerator doors or horizontal placement on benchtops.

Sample Compatibility & Compliance

The 56000-10 is optimized for ambient air monitoring in enclosed controlled environments—including biological safety cabinets (hoods), pharmaceutical cold rooms, ISO Class 5–8 cleanrooms, CO₂ incubators, desiccators, and environmental test chambers. It is not intended for direct immersion or pressurized process streams. Optional external probe variants (e.g., 56000-03 standard probe, 56000-00 buffered bottle probe, 56000-07 5 mL vaccine vial probe) extend its applicability to liquid baths, sealed containers, and thermal mass stabilization scenarios. Each unit ships with an individually numbered, A2LA-accredited ISO/IEC 17025:2017 calibration certificate (Laboratory ID 1750.01), documenting as-found/as-left values traceable to NIST Standard Reference Materials. This documentation satisfies GLP/GMP audit requirements for instrument qualification and supports IQ/OQ/PQ protocols in regulated facilities.

Software & Data Management

While the 56000-10 operates as a standalone logger without PC connectivity, its internal memory architecture ensures full compliance with data integrity principles outlined in ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate). All min/max values are timestamped with the integrated RTC and retained independently of user interaction. For facilities requiring electronic record retention, manual transcription into validated LIMS or ELN systems is supported by the device’s unambiguous display formatting and stable output resolution (0.1 °C, 1% RH). The ±1 °C temperature accuracy and ±5% RH mid-range accuracy align with common acceptance criteria defined in ASTM E2877-22 (Standard Guide for Monitoring Temperature and Humidity in Laboratories) and EU GDP Annex 9 for medicinal product storage.

Applications

• Continuous monitoring of refrigerator and freezer units used for vaccine, reagent, or biological sample storage—without requiring door opening.
• Validation of environmental stability in pharmaceutical stability chambers per ICH Q1 guidelines.
• Baseline environmental qualification of biosafety cabinets and laminar flow hoods prior to certification testing.
• Temperature and humidity trending in archival storage rooms for sensitive documents or reference standards.
• Supporting temperature mapping studies when deployed as a fixed-point reference node alongside wireless sensor networks.
• Compliance verification for ISO/IEC 17025 accredited testing laboratories maintaining environmental control per clause 6.4.1.

FAQ

Does the 56000-10 support data export or USB connectivity?
No. It is a self-contained, non-networked logger designed for visual verification and manual data capture. Export functionality is intentionally omitted to minimize cybersecurity risk and maintain regulatory simplicity.
Can the internal sensors be recalibrated in-house?
No. Recalibration requires traceable standards and environmental controls only available at A2LA-accredited laboratories. Users must return the unit to Cole-Parmer or an authorized service center for certified recalibration.
What is the recommended recalibration interval?
Annual recalibration is recommended for GxP-regulated use. Facilities may extend intervals based on risk assessment per ISO/IEC 17025 clause 7.8.3, provided historical performance data demonstrates stability.
Is the device suitable for freezer applications below 0 °C?
The base unit (56000-10) is rated for 0.0–50.0 °C. For sub-zero monitoring, select model 56000-03 with its external probe rated for –50 °C to +70 °C.
How is compliance with 21 CFR Part 11 demonstrated?
While the device lacks electronic signature capability, its immutable min/max memory, NIST-traceable calibration certificate, and human-readable audit trail (via timestamped visual display) satisfy §11.10(a) for “systems that do not require electronic records.” Full Part 11 compliance requires integration into a validated software platform.