Temperature mapping study and validation is mainly applicable for the pharmaceutical industry and food/FMCG industry. It helps us to analyze and ensure the uniformity of temperature distribution across all areas of the controlled areas under real life conditions.
Necessity of Temperature Mapping study
Temperature mapping study is required to test whether all areas of your asset maintaining same temperature as per your requirement. Typically temperature mapping study is required for the following type of assets:
- Warehouses normally between 15 to 25 Deg C.
- Cold Room normally maintaining a temperature between 2 to 4 Deg C.
- Walk in Chillers or Freezers which will maintain a temperature below zero Degree upto -40 Deg C.
- Refrigerators which keep medicines normally between 2 to 8 Deg C.
- Cold Storage used for food which may have different temperature ranges.
- Autoclaves which maintain particular temperature ranges.
- Humidity chambers which maintain particular range of humidity.
- Refrigerated Vehicle, Van & Reefers which maintain a temperature range such as 2 to 8 Deg C for medicine transportation.
- Thermally insulated passive boxes which maintain temperature for a certain duration.
- Active refrigerated boxes which are small refrigerators.
The analysis is done by analyzing the data under real-time operating conditions. For carrying out a temperature mapping study, numerous data loggers will be placed in the area and the data will be recorded continuously for a couple of days. The location of such data loggers will be marked in a 3D drawing and will become part of the report. All operations like loading, unloading, forklift movement etc. will happen as normal and such actions will be manually or digitally recorded to the extent possible. All such collected data will be analyzed and plotted as a graph to analyze the temperature uniformity across the entire area. Any abnormal variations if found will also be compared with the real-time operations happened at those particular times. Hot spots and cold spots will be identified in this study and corrective actions will be recommended.
Temperature & Humidity Mapping Study
For certain assets, you have to maintain humidity within permitted levels. eg. DHA, Dubai specifies that warehouses storing medicines should maintain a humidity below 65% RH. In this case, we have to test distribution of humidity also along with temperature. Hence we call it as Temperature & Humidity Mapping study.
The temperature study is carried out at least in two climatic conditions ie. Summer and winter. This will provide a detailed analysis of the area across various climatic conditions.
Apart from certification, various recommendation including the following will form part of the report:
- Are there any hot spots in the enclosed area? Are they rectifiable?If not, this area has to be isolated so that sensitive items are not stored in this area.
- If power fails how long the area is safe for the stored goods? This testing helps the customer to understand the required actions in case of a power failure.
- We can decide the location for placing your Sensors or recording instruments for continuous monitoring.
- How many people and machinery can occupy the area simultaneously?
- Any difference in behavior in Summer and Winter?
Hot spots and cold spots
Hot spots and cold spots of the area is determined as a result of the temperature mapping study. As the name indicates, a hot spot means the hottest point inside the area. The cold spot is the coldest recorded point. As an example for a warehouse after identifying the hot spot and cold spot, these points need to be continuously monitored using real-time temperature monitoring systems.
What is the difference between Temperature Mapping Study and Validation?
Temperature Mapping study is the study and analysis as explained above. This will provide a detailed analysis report for your enclosed area. This report provides confidence that the area is capable of maintaining the correct temperature.
Validation is mainly applicable for various systems used for controlling and monitoring of the controlled area. Validation of Electronic recording systems is carried out as per 21 CFR part11. This is the process of Validation. The mapping study also may be part of the whole process. However, the study has to be carried out and the electronic instruments used should be as per the international regulations such as 21 CFR Part 11. Accredited third parties have to certify the entire process and only then the certification process will be complete.
Temperature mapping study is known as Thermal mapping study and Temperature validation is known as Thermal validation as well.
We are associated with Cryopak, USA for providing certification for the clients in the Middle East & African region.
What is 21 CFR Part 11?
In general terms, this stipulates that all manufacturers and distributors of medicines, vaccines and related machinery should implement control measures and audits across various segments of the manufacture and distribution.
For life sciences, this refers to the recording of various critical data through all stages of manufacture, storage and distribution of goods so that all recorded data is accurate.
Also please see our detailed article on the same : What is 21 CFR Part 11