Temperature Mapping Study is a process carried out to analyze the temperature distribution inside a room. We carry out temperature mapping study for storage areas and carriages used for storage and transportation of temperature sensitive goods. This is as per GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) requirements.Typically such items are medicines, vaccines etc. Other terms used are Thermal mapping study, temperature distribution study etc. If you need to study humidity levels, then we carry out a temperature and humidity mapping study.
Temperature mapping study as per SFDA requirements
SFDA (Saudi Food and Drug Authority) has recently issued guidelines to Pharmaceutical distributors for Temperature Mapping study and Qualification. We have to store all the medicines at a certain temperature as recommended by the manufacturer throughout its cycle until used by the end user. After production of the medicine, it goes through various transportation and storage areas until it reaches the end user. If the medicine is not stored properly, the medicinal values will be completely lost. Certain medicines have to be stored between 2 and 8°C and certain other medicines at 15 to 25 °C.
Temperature mapping study is also known as Temperature distribution analysis. This study is generally carried out for ware houses, cold rooms, refrigerator, vans, reefers, boxes etc. which are used for storage and transportation of such medicines and vaccines.
As an example, a medicine manufacturer recommends that a particular medicine should always be kept between 2 to 8 °C. After the medicine leaves the factory there are various agencies involved such as the international transporter, a regional distributor, a local transporter, a local distributor etc. All these parties should keep this medicine within the specified temperature limits only as per GDP and GMP. If the medicine is subjected to temperature variations by any of these agencies during any stage of storage or transportation, the quality of the medicine is affected.
If a local distributor is using a temperature controlled van for distribution of the medicines, the temperature inside the van should be between 2-8 °C at all times. Even the door openings should be controlled so that the temperature does not go above the limits. Such a van should be subjected to a temperature mapping study before using the vehicle for distribution of such medicines.
What is temperature mapping study or Thermal mapping study?
As an example, we will consider a temperature controlled van which is used to transport a medicine between 2 and 8 Degree Centigrade.
The cooling unit is mounted generally on one corner of the cargo compartment of the van. The temperature inside the cargo compartment is maintained by a control unit mounted inside the driver cabin. The control unit can be set at a particular temperature eg. 5°C and the temperature inside the cargo chamber is supposed to be around 5°C at all times.
However, there are various other parameters affecting the uniform distribution of the temperature inside the cargo chamber. Even when the cargo chamber is completely empty, the entire area of this chamber may not be able to maintain a uniform temperature distribution within 2 and 8°C. eg. The corner far away from the cooling unit may reach temperature higher than 8°C, because of improper of air circulation. Another area near the cooling unit may reach temperature below 2°C at certain times. Both these conditions are harmful for the medicine and will affect its efficacy.
The driver of the van has no means to identify such a situation. He may be keeping the medicine boxes as per his convenience and available space inside the van. This will compromise the quality of the medicine inadvertently. In order to find out such variations, a Temperature Mapping Study needs to be carried out inside the van before using the van for such transportation purposes.
The same situation arises for other facilities such as warehouse, cold room, refrigerator, thermally insulated boxes, etc.
How to carry out Temperature mapping study
In order to carry out temperature mapping study, the temperature inside the area need to be recorded for a certain period continuously. This is done using Temperature Data Loggers. The data logger will be placed inside the closed area at various places, shelves etc.
The data collection will be done for couple of days or weeks depending on the type of asset and application. After downloading the data, we analyze the same for various conditions to generate the results of the mapping study
As a thumb rule, for areas such as warehouse with a wide temperature range, we place one Data Logger for every 10 cubic meters. For areas such as cold rooms with a narrow temperature range, we place one data logger for every 5 cubic meter.
All data loggers will start recording simultaneously and the recording continues for predetermined period. For a cold room, the data collection will be for 4-6 days. The data collection period will be 7-14 days for a warehouse. There is no need to carry out the study for a very long period. During a particular climatic season, the inside behavior remains almost constant. So if the study is carried out for couple of days, it will give an indication of the general behavior. It is ideal to include couple of working days and at least one holiday.
Temperature and Humidity Mapping study for GMP and GDP
In many countries, the external humidity is high. In such cases, humidity distribution also need to be studied. Hence Temperature and humidity mapping study is carried out in such cases. The entire procedure is the same as a Thermal mapping study. However in this case we use Temperature and Humidity Data Loggers. However for thermal mapping study temperature data loggers are used.
Generally for pharmaceutical storages, the humidity should be between 45% to 65%. This generally depend upon the type of medicines being stored. If you want to reduce high humidity, you have to use Dehumidifiers. If you want to increase humidity, you have to use Humidifiers.
If you are not sure whether you need temperature and humidity mapping study, it is better to check the specifications of the stored goods. The manufacturer of the goods recommends desired temperature and humidity levels as per their GMP and GDP standards.
What is difference between Temperature Mapping study and temperature qualification for cold room, warehouse, van etc?
Temperature Mapping Study only gives the behavioral pattern inside the area. A Temperature Qualification Study carries out detailed analysis of the area. This is to prove that design, installation and operation is in accordance with the desired results.
Eg. Consider that a complete set of qualification study is carried out for a cold room. It analyses that the whole set of the cold room and associated equipment such as cooling units are designed, installed and operated properly. The result should be that it will always achieve temperature between 2 and 8 Deg C. Such tests are not part of a mapping study explained in the previous section.
The company which carries out a qualification study needs to have expertise in mechanical and electrical engineering, since this involves a series of electrical and mechanical tests.
The qualification study generally involves the following procedures:
- Design qualification and verification to ensure that the asset and its equipment are designed to achieve the desired results. This process will involve verifying the design process of the asset. After verifying the design, it has to be verified that the installed equipment and the asset are as per this design documents.
- Installation qualification and verification is carried out next to verify that all the equipment and the asset itself are installed as per the design document and as per the installation instructions of the respective manufacturers
- Operational qualification and verification to verify that the equipment are operated as per the recommended methods of the manufacturers.
- Temperature distribution study to analyze the distribution study. If humidity is also to be studied, temperature and humidity mapping study is carried out.
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