Expertise Thermal Validation Testing & Inspection Services

Thermal Mapping &
Validation Solutions

Thermal mapping involves documenting, executing, and evaluating the validation of temperature-controlled units (TCUs) and warehouses, crucial for safeguarding time and temperature-sensitive pharmaceutical products (TTSPP). Its primary goal is to ensure temperature and/or humidity levels within these controlled units adhere to required specifications.


Thermal Validation Mapping_boxed


A full mapping approach of newly installed CTU is generally executed when the system is not yet in use. It consists of:


  • Static empty chamber study with determination of hotspot and coldspot to determine monitoring sensor(s) placement
  • Placement of the monitoring sensor(s)
  • Static loaded chamber study
  • Dynamic loaded chamber study consisting of door openings, power failure and power recovery test.


The duration of a study of a storage area influenced by the outer temperature is at least 7 days, the duration of a storage area not influenced by the outer temperature (e.g. refrigerator) is at least 24 hours. These periods may differ per customer.

Thermal mapping of temperature controlled warehouse

As an example, we shortly explain how a thermal mapping of temperature controlled warehouse is executed.

The validation of the warehouse (15°C – 25°C) will include temperature and/or humidity mappings performed during summer and winter conditions if the temperature of the ambient warehouse can be influenced by outside temperature.

Prior to the dataloggers placement, the following factors could contribute to the temperature variability in a warehouse:

  • Size and Height of the warehouse
  • HVAC locations
  • Racks & shelving
  • Doors & windows
  • Weekly workflow variation (human factors and traffic patterns)
  • Environmental impacts
  • Areas where products are stored


To ensure that all above factors are taking into account, the floor plan of the warehouse should be used as a schematic diagram for the dataloggers placement. For smaller CTUs we usually work according to the ‘box model’, but as the systems gets bigger or more complex more loggers can be placed.

If you have 50 temperature-controlled units that require a validation within a short deadline, Agidens can make it work.

Magali Polfliet Project manager Testing & Inspection Services



  • Over 25 years of experience in thermal validation studies
  • Qualification of over 500 CTUs
  • We supported over 20 customers with thermal mappings
  • Net Promotor Score of 8,125
  • Our SMEs support in setting up a mapping approach, root cause analysis on deviations …


FertiPro sought and found a partner in Agidens for the annual revalidation and initial validation of a new cleanroom and autoclaves.  Our Validation & Testing Engineers conducted a series of tailor-made validation tests based on carefully designed test protocols to ensure high-quality process and equipment validation.

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