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MadgeTech Ultra Low Temperature Freezer Validation System
Can be used for validation, mapping, stabilization studies and temperature surveys
Manufacturer: MadgeTech ULT909
Includes: USB docking station with 6 ft. of cable (15-060-038), 9 or 15 Cryo-Temp data loggers with N.I.S.T. Calibration Certificates, and Madgetech's FDA 21 CFR Part 11 Secure Software and IQ/OQ/PQ validation protocols.
Description
Provides a complete stand-alone temperature mapping and validation solution for freezers of all sizes and configurations. It includes Cryo-Temp dataloggers, a USB docking station with 6 ft. of cable, MadgeTech's Secure FDA 21 CFR Part 11 software and IQ/OQ/PQ validation protocols. It can be fully customized to include user-specified quantities of each item in the system to accommodate specific applications.
- Splash-resistant unit can measure and record temperatures as low as -86°C
- To provide data integrity and meet requirements of FDA 21 CFR Part 11, the secure software includes electronic signatures, access codes, a secure data file and an audit trail
- For large freezers, the software can graph datasets from multiple loggers to show variances in different parts of the freezer; this can reveal air stratification, hot spots and anomalies in chilling systems
- Available with 9 or 15 Cryo-Temp dataloggers or the system can be completely customized to meet the validation needs of a specific freezer
- IQ/OQ/PQ Validation protocols
- Temperature range: -86°C to +35°C
- Resolution: 0.1°C
- Accuracy: ±1°C
- Battery life: One year at -80°C
- User-programmable temperature alarms with LEDs (OK, warn, and alarm)
- Hardware and software password protection, memory wrap, user-programmable start times, sample intervals, logger descriptions, unique IDs
- Memory: 32,767
- Reading Rate: 5 seconds up to 30 minutes
- Single/Multi-Use: Multi-use
- Battery Life: 2 years typical at 25°C, 1 min. reading intervals; 1 year typical at -80°C, 1 min. reading intervals
- Material: ABS plastic
- Dimensions: 3.3 x 2.1 x 0.4 in., (8.3 x 5.4 x 1.1cm)
- Operating Environment: -86 to +35°C (-122.8 to +95°F), 0 to 95% RH
- Required Interface Package: USB Docking Station (Cat. No. 15-060-038)
- Temperature Sensor: Thermistor
- Temperature Range: -86 to +35°C (-122.8 to +95°F)
- Temperature Resolution: 0.1°C (0.18°F)
- Temperature Calibrated Accuracy: ±1.0°C (1.8°F)
Ultralow freezer validation, Ultralow freezer mapping, Ultralow freezer stabilization studies, Temperature surveys: reveal stratification of air, reveal hot spots, reveal anomalies in chilling systems.
Certifications
NIST traceable calibration certificates
Compliance
CE approved; FDA 21 CFR Part 11 Compliant.
Specifications
2 Years at 25°C, 1 Year at -80°C | |
32767 Readings | |
ULT90-9 | |
Digital calibration | |
0 to 100% | |
To provide a complete stand-alone temperature mapping and validation solution for freezers to ensure uniform storage and testing conditions | |
0.1°C | |
Thermistor | |
0.03kg |
3.6V Lithium | |
-86° to 35°C | |
One USB docking station with 6 ft. of cable, 9 Cryo-Temp dataloggers, MadgeTech's secure software and IQ/OQ/PQ validation protocols | |
CE, FDA 21 CFR Part 11 | |
Ultra Low Freezer Validation System | |
ABS Plastic | |
-86° to 35°C | |
1.4 oz. |
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