MadgeTech™ Ultra Low Temperature Freezer Validation System

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

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.

Catalog Number	Mfr. No.	Includes	Model
15-060-411	MadgeTech™ ULT9015	One USB docking station with 6 ft. of cable, 15 Cryo-temp dataloggers, MadgeTech's secure software and IQ/OQ/PQ validation protocols	ULT90-15
15-060-410	MadgeTech™ ULT909	One USB docking station with 6 ft. of cable, 9 Cryo-Temp dataloggers, MadgeTech's secure software and IQ/OQ/PQ validation protocols	ULT90-9

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

• Type: Ultra Low Freezer Validation System
• Calibration: Digital Calibration
• Battery Life: 2 Years at 25°C, 1 Year at -80°C
• Material: ABS Plastic
• For Use With (Application): To provide a complete stand-alone temperature mapping and validation solution for freezers to ensure uniform storage and testing conditions
• Temperature Resolution: 0.1°C
• Operating Temperature (Metric): -86°C to +35°C
• Weight (Metric): 0.03 kg

• Data Memory: 32,767 Readings
• Battery Type: 3.6 V Lithium
• Certifications/Compliance: CE, FDA 21 CFR Part 11
• Sensor Types: Thermistor
• Humidity Range: 0 to 100%
• Temperature Range (Metric): -86°C to +35°C
• Weight (English): 1.4 oz.