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Facility Thermal Mapping

Every drug has stability data that dictates its required temperature storage range. The FDA requires that drugs be stored under appropriate temperatures so that their identity, strength, quality, effectiveness and purity are not affected. However, many variables impact temperatures within a facility, including airflow, facility layout, traffic patterns and seasonal extremes.

Sensitech’s Facility Thermal Mapping (FTM) studies are the most efficient way to determine the precise temperature profile of – and variances within – a facility. Wireless, self-contained TempTale 4 monitors are easy to install, and can be placed anywhere in your facility for maximum flexibility and to detect issues in suspected problem areas.

This cost-effective service is for managers who need to document their warehouse, storage facility or cooler’s temperature cycles in order to prove they can safely store products. Once downloaded, Sensitech’s validated monitors provide detailed, accurate reports on the thermal variances within your warehouse.

Benefits
Identifies hot and cold spots in a facility
Captures variations in temperature over time, as well as locations
Provides insight on the efficiencies of the HVAC and ventilation systems
Provides documentation that illustrates the temperature profile of the facility
Provides documentation in support of 21 CFR 211 Part 142
Provides information on the location of wireless monitors or strip chart recorders in the facility
Monitors are non-intrusive to implement—no technicians required—and easy to use
All equipment used in the FTM study is tested to NIST traceable standards

All equipment comes with a Certificate of Validation

Download Facility Thermal Mapping Data Sheet (PDF Document)

For more information on these studies and how we can help you comply with 1079 Guidance, complete our online form. Be sure to reference 1079 in the comment section.

 

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