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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
The entire procedure including the types of tests to be carried out, number and location of data loggers etc. are written in a procedure known as test protocol. Upon completion of the tests, the data loggers are collected and the data is downloaded. The data thus obtained are analyzed in our special software and evaluated and a report is generated.
Now we will explain about Temperature qualification.
There are many customers who require a qualification study and certification. This process involves additional tests apart from the temperature mapping study. A qualification process involves checking and testing of all major and minor equipment installed in the cold room and certifying that the whole set of installation including cooling units are capable of maintaining the required temperature. In a mapping study, adequacy and functioning of the installed equipment are not verified.
Even though this video explains only about cold room for temperature mapping and qualification, the principles and procedures are generally same for all other assets such as warehouses, vans, reefers, refrigerated trucks, refrigerators, freezers etc..
Also such studies are carried out for autoclaves, furnaces etc. to ascertain that they maintain proper temperature.