Temperature validation or thermal validation is the process of validating a process or an asset. An asset is validated to ensure that the asset is capable of storing or transporting the goods at the desired temperature.

The following are the normal temperature validation processes related to assets:

1. Thermal validation of Cold rooms and walk-in freezers.
2. Thermal validation of vans and reefer trucks.
3. Thermal validation of warehouses.
4. Thermal validation of passive and active cooling boxes.
5. Thermal validation of autoclaves.

The validation tests involves all processes covered under qualification and mapping study for each of those assets. The terms validation and qualification are often used interchangeably as well.

However validation is more important for processes. As an example consider that you want to validate the entire process from storing to the distribution of medicines. In this case you have to analyze the entire process from packing to loading to the vans, delivering to the pharmacy etc. Such an analysis is done to ensure that the entire process doesn’t compromise quality of the medicines. After such validation process, the sequence can be included in the SOP (Standard operating procedure) as well.

Thermal validation also generally includes all the processes from manufacture, storage to distribution of medicines. Hence this validation is also known as cold chain thermal validation or simply cold chain validation. If you are a whole sale distributor of medicines, the thermal validation of your operations will include the following:

1. Receiving the goods at the airport and transporting to your warehouse.
2. Unloading process and stacking process in your warehouse.
3. Storage for couple of weeks or months as per your normal cycles.
4. Loading to smaller vehicles for local distribution.
5. Transporting to distributors, hospitals, pharmacies etc.

The whole process will be tested in the process of thermal validation to check that the temperature is maintained throughout the complete process. Once thermal validation is completed, you can incorporate the findings in your SOP (Standard operating Protocol). This protocol will be the guidelines for your complete operation team. Thermal validation includes temperature mapping of the assets as sell as verification of the processes.