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MadgeTech™ Ultra Low Temperature Freezer Validation System

Can be used for validation, mapping, stabilization studies and temperature surveys

Manufacturer:  MadgeTech™ ULT9015

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Catalog No. 15-060-411


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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

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
General Specifications:
  • 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:
  • 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)
Note: Not compatible with 64 bit operating systems or Windows™ 7.

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

Specifications

2 Years at 25°C, 1 Year at -80°C
32767 Readings
ULT90-15
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, 15 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.
SDS
Documents
Accessories
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