Thermal Mapping or Thermal Validation is the method of validating or qualifying equipment and storage facilities, e.g., warehouses, storage facilities, refrigerators, freezers, incubators, cryo-apparatus, autoclaves, depyrogenation ovens and tunnels, lyophilizers, photostability chambers, SIP systems, etc., that you claim will maintain a defined temperature range or profile during their intended use and operation.  Thermal mapping determines if the facility or equipment will maintain the temperature range you claim under your actual conditions of use.

If you are in the pharmaceutical, biotechnology, or healthcare industries, you need to have properly maintained, calibrated, and validated equipment and facilities, not just for regulatory compliance but for reliable and profitable operations. You need to do thermal mapping of your temperature controlled equipment.

What are the tests performed during thermal mapping?

You want to do a risk assessment before you do the thermal mapping so you can identify all of the tests you need to do based on your risks.  You identify the required tests for your thermal validation study based on your risk assessment.

Common tests for refrigerators, freezers, and incubators include

  • Temperature Distribution Test (Empty Chamber)
  • Temperature Distribution Test (Loaded Chamber)
  • Pull-down Tests
  • Door Open Tests
  • Power Loss Tests
  • Alarm Tests
  • Recovery Time Tests

Common tests for Autoclaves, Dry Heat Ovens, Depyrogenation Lines, Pasteurizers, etc., include

  • Temperature Distribution Test (Partial Load)
  • Temperature Penetration Test (Loaded)
  • Pull Down Tests
  • Accumulated Lethality (Fo and FH) Tests

Other tests to consider based on your risk assessment include

  • Compressor Switch Over Tests
  • Compressor Failure Tests
  • Fan Failure Tests
  • Emergency Generator Cutover Tests
  • Routine Use Tests

How is Thermal Mapping done?

Thermal mapping involves the placement of an array of pre-calibrated temperature, temperature and humidity, or temperature and other parameter data-logging sensors in pre-defined locations within the enclosed space or the equipment.  You start the data-logging sensors and run the tests specified in your approved thermal validation study protocol.  You want to run the thermal validation study long enough to go through the planned defrost cycles for your equipment.  If you are mapping warehouses or facilities, you may want to consider mapping studies in both a hot, dry summer month and in a cold, wet winter month to show that no matter what the weather conditions your facility meets your specifications.  After the thermal mapping study, the sensors are post-calibrated to assure that the sensors are still operating as you expect.

How long does thermal mapping take?

A thermal mapping study takes one to two weeks, including the time to prepare and approve the protocol, pre-calibrate the sensors, the actual testing, and the post-calibration of the sensors.  Typical thermal mapping study execution times are in these ranges.

  • Temperature-controlled units (run duration or 24-72 Hours)
  • Warehouse/Dry Storage Facility (1 Week)
  • Cold Storage (24 Hours to 1 Week)

Results

The thermal mapping output is temperature (and other parameters) versus time report at each location.  The thermal map is a temperature (and other parameter) data plot for each location over time.   The final study report demonstrates that your equipment or facility can meet your specifications when you operate it as you intend to operate it.

PSC Biotech is the right thermal mapping service

If you need thermal mapping services, calibration services, and state-of-the-art wireless or wired equipment to do thermal mapping validation of your equipment and/or facility, contact PSC Biotech. Our thermal mapping experience and supply of calibrated state-of-the-art wireless and wired sensors can meet all your needs for thermal mapping.

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