Following your products from storage to shipment and ensuring their regularity and compliance is paramount. Performing a Temperature Mapping Study can confirm that your assets are compliant and safe.

The objective of a Temperature Mapping Study is to document temperatures within defined areas where temperature sensitive products are stored or shipped. This can range in size from a small refrigerator to transport trailers and large warehouses. Using our proven analytical process, the Mesa team works with your staff to not only conduct a temperature study, but also to empower your staff with the know-how to improve your processes and environments.

If it is discovered during an audit that temperature mapping has not been completed and it is determined that the raw materials, in-process materials, finished products, and components are not being stored in the correct environmental conditions, a company could be exposed to FDA Form 483 observations, and even potential product recalls.

Our temperature mapping process follows a comprehensive and proven methodology, including:

  • Mapping protocols adapted to the unique needs of your environment, and its conditions.
  • Before a study begins, protocols are reviewed and pre-approved by your staff
  • Calibrated and independent N.I.S.T. traceable temperature data loggers (no hardwiring)
  • Documentation of environmental conditions that identify the temperatures recorded over the life of the study, and the thermal variations within the studied areas at any given time
  • Calculation of mean kinetic temperature (MKT) within each unique area being studied
  • Multi-seasonal comparisons that can include winter, summer, spring, and fall
  • Pre-qualification studies that can pave the way for new or expanded storage areas
  • Identification of locations within the studied area that demonstrate high and low temperatures (hot and cold spots) as compared to the desired temperature range for the area
  • Location of temperature collection points for on-going monitoring
  • Follow-up with your staff to address any adverse situations identified as part of the study

Experience the Mesa Difference.  Get a no-obligation quote today!