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Temperature mappings are the studies of temperature behaviors and distributions across a room. When it comes to protecting thermosensitive products and understanding the risks related to storage environments, temperature mappings are fundamental, as they can demonstrate how well an equipment or a storage can protect products and help mitigate temperature excursions. It also ensures compliance with enforced regulations and provides a significant amount of temperature data to process and analyze, leading to an in-depth knowledge of your facilities.
Temperature Mapping: The Initiation Process
Before starting a temperature mapping, the first thing that needs to be established is the set of requirements and methodology to follow. This information usually comes from governmental agencies such as Health Canada, the USP or the FDA, industry standards and best practices, corporate quality procedures and policies, and product requirements. The gathered information should provide answers to the following:
What temperature limits should be used for handling and storing temperature-sensitive products.
What outdoor temperatures should be reached to ensure a challenging test environment during the mapping study (Worst-Case conditions, usually summer and winter seasons).
How long should the mapping last.
Which type of calibrated temperature data loggers should be used.
Where should the calibrated temperature data loggers be installed to cover critical storage locations.
What type of assessment should be conducted on air conditioning systems and equipment.
What kind of results are expected from the mapping.
Who reviews and accepts the results.
Once all of the above questions are answered, the information is then consolidated into a protocol which serves as the basis for temperature mapping execution, data analysis, and reporting. The protocol should always be reviewed and approved by all parties involved, as well as be executed by a qualified team.
Now that the protocol is ready, the mapping study can be executed. This process is simple as it translate into the application of all the steps described in the approved methodology. At this point, the calibrated data loggers are configured and installed at prescribed locations and the mapped area is assessed as per the protocol.
Temperature Mapping: The Analysis.
Once the execution is completed and all data loggers have been retrieved, it is time to perform the analysis. Temperature data analysis is the core of temperature mappings. It is used as the basis for providing science-based recommendations and demonstration of storage space effectiveness, with a high level of confidence. It allows for trends to be identified along with temperature excursion risk areas, commonly known as Hot & Cold Spots, and can also provide insight on how well air conditioning systems and equipment are working and help detect anomalies. Since most temperature mappings are seven to ten days long, with measurement recorded every five minutes, many temperature values are captured, translating into a large data set to work with.
From this information, statistics and probabilities can be calculated. For example, the minimum, the maximum, the mean, and the median temperatures gives you information on the data spread, when combined, helps you define the temperature uniformity. One other important statistic to utilize during an analysis is the standard deviation, a measure of dispersion across a set of values that provides information on the temperature fluctuations per location, telling you how stable your storage environment is. The probability of occurrence can then be calculated for temperature above or below acceptance limits, allowing for recommendations to be made on how to reduce its likelihood.
Temperature Mapping: The Conclusion
After gathering all the information related to the storage areas and analyzing all the captured data, a final report should be prepared. The report usually includes all the findings and supporting documents, temperature charts, summarized data tables and statistics, to support the conclusions and recommendations provided in the executive summary. The recommendations should help you determine:
The actions to take for improving the level of temperature control across your storage areas.
How to reduce the likelihood of temperature excursions where Hot & Cold Spots were identified.
Where permanent temperature sensors should be installed for continuous monitoring purposes.
Raw Data reports and calibration certificates should always be included for the reader to verify. Temperature mapping reports are also used during external quality audits to demonstrate the following:
Thermosensitive products are stored in appropriate conditions.
Auditees are compliant with applicable regulations and standards
Temperature behaviors of critical storage locations are understood.
Permanent temperature sensor locations were justified using sound data.
In conclusion, important information can be inferred from temperature mapping data and results. Completing such studies can help you make better decisions and further protect your temperature-sensitive products, but more importantly the end users or patients health.
