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Traceable 94460 Digital Temperature and Humidity Meter with NIST-Traceable Calibration Certificate

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Brand Traceable
Origin USA
Model 94460
Instrument Type Multi-Channel
Certification NIST-Traceable Calibration Certificate
Compliance Meets ISO/IEC 17025 calibration requirements for accredited laboratories

Overview

The Traceable® 94460 Digital Temperature and Humidity Meter is a precision-engineered environmental monitoring instrument designed for laboratory, cleanroom, pharmaceutical stability chamber, and quality control applications where traceable, repeatable measurements of ambient conditions are critical. Built on dual-sensor architecture, it simultaneously acquires and displays real-time temperature (°C/°F) and relative humidity (%RH) using high-stability capacitive polymer humidity sensing elements and precision thermistors. All units ship with an individually numbered, NIST-traceable calibration certificate issued by an ISO/IEC 17025-accredited calibration laboratory—ensuring metrological validity per international standards including ISO 9001, ISO 14644, and FDA 21 CFR Part 11–compliant data integrity frameworks.

Key Features

  • Multi-channel capability supports up to four independent sensor inputs (configurable via optional external probes), enabling simultaneous monitoring of multiple locations or zones within a single system.
  • Backlit LCD display with dual-parameter readout (temperature + RH) and intuitive navigation buttons for zero-point offset adjustment and unit switching.
  • Internal data logging function stores up to 16,000 timestamped measurement records at user-selectable intervals (1 sec to 24 hr), supporting post-hoc trend analysis and audit-ready reporting.
  • Rugged ABS housing rated IP54 for dust and splash resistance; operating range: –20 °C to 60 °C (–4 °F to 140 °F), 0–100 %RH non-condensing.
  • Built-in alarm thresholds with visual and audible alerts for out-of-specification excursions—configurable per channel to support ICH Q1/Q5 environmental qualification protocols.
  • USB interface (Type-A) enables direct connection to Windows-based PCs for firmware updates, data export in CSV format, and integration with validated environmental monitoring systems (EMS).

Sample Compatibility & Compliance

The 94460 is optimized for ambient air monitoring in controlled environments—not intended for immersion, high-pressure, or corrosive gas applications. Its sensor design complies with ASTM E2251–23 (Standard Specification for Liquid-in-Glass and Digital Thermometers) and ISO 7726 (Ergonomics of the thermal environment – Instruments for measuring physical quantities). The included NIST-traceable certificate documents measurement uncertainty at key points across the operating range (e.g., 23 °C ± 0.5 °C, 50 %RH ± 2.5 %RH), fully aligned with ISO/IEC 17025 Clause 6.5 on calibration validation. For GxP-regulated environments, the device supports ALCOA+ data integrity principles when used with appropriate procedural controls and periodic re-calibration (recommended annually or per internal SOP).

Software & Data Management

No proprietary software installation is required for basic operation or data retrieval. Raw logged data exports directly as comma-separated values (CSV) via USB mass storage mode—compatible with Excel, LabVIEW, Python pandas, and LIMS platforms. For regulated users, the meter’s time-stamped records include embedded metadata (sensor ID, acquisition timestamp, battery status), satisfying FDA 21 CFR Part 11 requirements for electronic records when paired with organizational access controls and audit trail documentation. Optional TraceableLink™ desktop application (v3.2+) provides automated report generation, statistical process control (SPC) charts, and deviation flagging—validated for use in GLP and GMP settings.

Applications

  • Pharmaceutical stability testing chambers (ICH Q1A–Q1E compliance verification)
  • Biological safety cabinet and incubator environmental qualification (IQ/OQ/PQ)
  • Warehouse and cold chain temperature/humidity mapping studies
  • Microelectronics cleanroom environmental monitoring per ISO 14644–2
  • Calibration lab reference standard verification and inter-lab comparison exercises
  • Educational labs requiring metrologically defensible student measurement tools

FAQ

Is the NIST-traceable certificate included with every unit?
Yes—each 94460 ships with a unique, laminated calibration certificate bearing the accrediting body’s logo, measurement points, uncertainties, and expiration date.
Can the internal logger be configured for continuous recording over 30 days?
Yes—when set to 1-minute intervals, the 16,000-record buffer supports ~11 days; for longer durations, reduce sampling frequency (e.g., 5-min intervals yield ~56 days).
Does the device meet FDA 21 CFR Part 11 requirements out-of-the-box?
The hardware and data output comply with technical criteria; full Part 11 compliance requires site-specific procedural controls (e.g., user authentication, audit trail review, electronic signature policy).
Are external probes compatible, and what types are supported?
Yes—optional Traceable® Series 9000 probe assemblies (e.g., 9001-01 stainless steel RTD, 9002-02 thermocouple extension) connect via standard 3.5 mm jacks and retain full calibration traceability.
What is the recommended recalibration interval?
Annual calibration is advised per ISO/IEC 17025 and most internal quality management systems; more frequent verification may be required in high-use or critical environments.

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