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Ultra Low Freezer Validation System

By Pharmaceutical Processing | December 1, 2010

The ULT90 can be used for validation,
mapping, stabilization studies and temperature surveys. The ULT90 provides a
complete temperature mapping and validation solution for freezers of all sizes
and configurations. It includes Cryo-Temp data loggers, a USB docking station, and the company’s secure FDA 21 CFR Part 11 software and IQ/OQ/PQ validation
protocols. The ULT90 can be fully
customized to include user-specified quantities of each item in the system to
accommodate specific applications. The Cryo-Temp data logger can measure and
record temperatures as low as -86°C and is splash resistant. To provide data integrity, and meet the
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. The ULT90 is available with 9 Cryo-Temps (ULT90-9), 15 Cryo-Temps
(ULT90-15) or the system can be completely customized to meet the validation
needs of a specific freezer (ULT90-Custom).

MadgeTech, Inc., Contoocook,
NH 03229.
www.madgetechlifesciences.com
or call 603-456-2011

 

INTERPHEX 2011 Booth No. 2058

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