MADGETECH TransiTempII and Cryo-Temp Temperature Data Loggers

Overview

The MADGETECH TransiTempII and Cryo-Temp series are compact, standalone temperature (and humidity, in the case of TransiTempII-RH) data loggers engineered for long-term, unattended environmental monitoring in regulated and non-regulated settings. These devices operate on the principle of precision thermistor-based sensing, with factory-calibrated analog-to-digital conversion and internal non-volatile flash memory for secure, timestamped data storage. Designed for deployment across cold chain logistics, pharmaceutical stability chambers, laboratory incubators, cryogenic freezers, and warehouse validation studies, each logger features a robust epoxy-sealed housing rated IP67 for dust and water resistance. The TransiTempII supports standard ambient and refrigerated environments; the Cryo-Temp variant extends operational capability into ultra-low-temperature domains down to –86 °C—enabling traceable thermal profiling in liquid nitrogen vapor-phase storage and mechanical ultra-low freezers. All models comply with fundamental data integrity requirements for ISO 17025-accredited labs and support ALCOA+ principles through immutable audit trails and time-synchronized logging.

Key Features

• High-stability NTC thermistors with NIST-traceable calibration certificates available upon request
• Programmable sampling intervals from 1 second to 18 hours, configurable via MADGELog software
• Internal real-time clock (RTC) with ±2 ppm accuracy over 0–50 °C, ensuring precise timestamping independent of host connection
• On-device LED status indicator for battery level, memory full, and active logging states
• Low-power design enabling up to 12 months of continuous operation on a single CR2032 coin cell (at 1-min interval, 25 °C ambient)
• Auto-start/stop triggers based on time, temperature thresholds, or external contact closure (via optional accessory port)
• Integrated USB-A interface for direct plug-and-play data retrieval—no drivers required on Windows, macOS, or Linux

Sample Compatibility & Compliance

These loggers are not sample-contact instruments but serve as validated environmental monitors for containers, chambers, shippers, and storage units holding biologicals, APIs, vaccines, or reference standards. They meet essential performance criteria referenced in USP , EU GMP Annex 15, and WHO Technical Report Series No. 961 for temperature mapping and qualification. While not intrinsically safe, they are suitable for use in non-hazardous locations per IEC 61000-4 electromagnetic compatibility standards. Data files generated are CSV- and PDF-exportable with embedded metadata (serial number, firmware version, calibration date, user-defined location ID), supporting 21 CFR Part 11 readiness when used within a validated MADGELog software environment featuring electronic signatures and audit trail review capabilities.

Software & Data Management

MADGELog v5.x is the native configuration and analysis platform, compatible with Windows 10/11 and macOS 12+. It enables full parameter setup—including logging start mode (immediate, delayed, or trigger-based), alarm thresholds, and custom naming conventions. Raw binary logs are decrypted and converted into calibrated, linearized temperature (and RH) values using embedded sensor-specific coefficients. Export options include annotated PDF reports with pass/fail evaluation against user-defined limits, overlay plots for multi-logger comparison, and automated Excel-compatible CSV generation with ISO 8601 timestamps. Audit trail records capture all configuration changes, data exports, and calibration updates—retained for minimum 10 years per internal SOP templates aligned with GLP and GDP guidelines.

Applications

• Real-time validation of shipping containers during clinical trial material transport (ICH-GCP compliant)
• Continuous temperature mapping of walk-in stability chambers per ICH Q5C and USP
• Monitoring of ultra-low freezer performance during routine PQ and annual requalification
• Environmental surveillance in cleanrooms and aseptic processing suites (ISO 14644-1 Class 5–8)
• Post-thaw viability assessment of cell therapies by correlating thermal exposure history with functional assay outcomes
• Supporting root cause analysis during out-of-specification (OOS) events in QC release testing workflows

FAQ

Can the Cryo-Temp logger be used inside a liquid nitrogen dewar?
No—it is rated for vapor-phase environments down to –86 °C, not direct immersion in cryogenic liquids.
Is firmware upgrade supported in the field?
Yes, via MADGELog software; all updates preserve existing logged data and calibration parameters.
Do these loggers meet FDA requirements for electronic records?
When deployed with MADGELog’s Part 11-compliant configuration (user authentication, audit trail, e-signature), they satisfy predicate rule requirements for record retention and integrity.
What is the recommended recalibration interval?
Annually—or per internal quality policy—using an accredited metrology lab with traceability to NIST SRMs.
Can multiple loggers be synchronized to a common time source?
Yes, via MADGELog’s batch time-sync function prior to deployment, achieving sub-second alignment across distributed units.