What is temperature mapping study, qualification and certification?

This video gives a brief idea about carrying out temperature mapping study and qualification for warehouses, cold rooms, vans, reefers, refrigerators etc. which are used for storage and distribution of temperature sensitive products including medicines, vaccines etc..
This video explains about a cold room in general, but is applicable for all other type of assets mentioned above.
Firstly we will explain about temperature mapping study.
The purpose of the temperature mapping study is to verify that the entire enclosed area maintains a temperature within the permitted levels. As an example a cold room for storing medicines should maintain a temperature level between 2 and 8 Degree Centigrade throughout the entire area of the cold room especially on the racks where medicines are stored. A temperature study involves collection of temperature data around the length and breadth of a cold room for couple of days and analyzing the data to check whether the temperature was within the limits at all times. In many cases, humidity also need to be mapped and may have to be maintained typically within a maximum humidity range of 60 or 65%. This is called Temperature and humidity mapping study.
The process identifies hot and cold points of the cold room which means those areas which exceeded the permitted levels of 2 and 8 Degree centigrade. Corrective actions will be required to resolve these issues. If corrective actions are not effective, these areas will have to be isolated and should not be used for storage of such sensitive medicines.
The procedure for the study is to place numerous data loggers inside the cold room. The location and number of data loggers mainly depend on the number and position of the racks, doors etc..
However generally one data logger should be used for every 5 cubic meters. In any case all racks should have data loggers. While deciding the location of the data loggers, other parameters such as location of the cooling unit, location of dehumidifier etc. also are considered.
For a cold room, the data is typically collected for 3 to 4 days. There are different tests carried out during these days. The basic principle is to collect the data at different operating conditions. Major tests are:
1. Data collection in an empty condition to analyze whether the temperature distribution is uniform
2. Data collection when the cold room is loaded up to 60% of capacity to analyze whether the temperature distribution is uniform under such conditions
3. Data collection when the cold room is fully loaded to analyze whether the temperature distribution is uniform under such conditions
4. Power failure test to analyze the duration for which the temperature will remain within the limits after a power failure
5. Door opening test to analyze the duration for which the temperature will remain within the limits after opening a door