Ultra-Low Temperature Freezer Validation System
The Madgetech ULT90 is an ultra-low temperature freezer validation system, measuring temperatures as low as -86 °C (-122.80 °F). This system provides a complete temperature mapping and validation solution to ensure proper storage and testing conditions.
The system includes:
- 9 or 15 CryoTemp ultra-low temperature dataloggers
- 1 IFC300 docking station
- 1 Madgetech 4 Secure Software and IQ/OQ/PQ validation protocols
The CryoTemp dataloggers provide 32,767 date and time-stamped temperature readings with an accuracy of ±1.0 °C (1.8 °F). Equipped with high/low alarm limits and high/low warning limits, the user will be alerted when the temperature nears unacceptable levels.
The MadgeTech 4 Secure Software aids users in compliance with 21 CFR Part 11 requirements. The software ensures electronic signatures, access codes, secure data files, and audit trails meet standards.