In this article, you will learn about thermal mapping distribution studies using Temperature Data Loggers for environmental monitoring and other validation studies in Puerto Rico. Also, you can discover how to get a Thermal Mapping Validation Template and Validation Management Software Application to handle your qualification activities fast and easily.
A Temperature Mapping is a formal evaluation of the temperature distribution within a determined space area. (e.g. Cleanroom, lyophilizer, incubators, warehouses, etc.).
This study is particularly useful when your product is sensitive or affected by temperature and is important to have control over the temperature conditions within specification limits. (e.g. storage of the COVID 19 vaccines, insulin medications, and others)
Since temperature conditions may vary in each location, sensors are distributed throughout different sampling points of the pre-defined locations to confirm it performs within pre-established specification limits.
Thermal studies may include several kinds of challenges and tests such as Thermal Mapping Distribution Studies
1. empty mapping,
Different testing can be performed to determine the position in which the permanent temperature chart recorders, probes or sensors must be installed for continuous monitoring and alarm.
The thermal mapping study must be capable to demonstrate and correlate that the temperature and relative humidity conditions measured with the permanent sensors are representative of the environment condition measured with the data loggers distributed in each separate location.
Recommendations to Avoid Mistakes Selecting Temperature Data Loggers.
We suggest evaluating all your requirements and needs to use temperature data loggers, but, also consider the frequency of use monthly, and how fast you need them on-site for your validation study. Thermal Mapping Distribution Studies
So, you can determine if is better to buy or rent them based on the expertise and time availability of your employees to configure and prepare the trending graphs and summary statistical reports on time.
Before buy, consider the cost of the data loggers, but, also the cost of the calibration and its lead time.
Evaluate and compare the total costs and lead times, against the costs to rent data loggers already calibrated.
If you are NOT using temperature data loggers frequently, consider a fast CIQA rental of the calibrated data loggers required for the thermal study. Thermal Mapping Outcomes
One of our data logger experts can set up, configure and bring to you the data loggers ready to use and be installed to collect information from your thermal mapping study. At the end of your monitoring, you can send the data loggers back to us for data extraction, evaluation, and perform the statistical analysis and plotting with averages, maximums, and minimums. For more information about services to make the initial setup, configuration, and statistical summary reports with trending graphs, click here.
THERMAL MAPPING PROTOCOL TEMPLATE THERMAL MAPPING DISTRIBUTION STUDIES
In case you need to create or update your thermal mapping protocol, you can use our template protocol to accelerate the process to perform the validation study and monitoring. To download a free sample of a thermal mapping protocol template in .pdf format, click here.
VALIDATION MANAGEMENT SOFTWARE APPLICATION
Moreover, soon you can get a Validation Management Software Application to handle all your qualification and validation documents from anywhere at any time.
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CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. Rest assured of the safety or being in the right hands.
IF YOU HAVE ANY QUESTIONS ABOUT HOW TO MAKE THERMAL MAPPING DISTRIBUTION STUDIES, FEEL FREE TO CONTACT US EITHER BY EMAIL OR PHONE: 787-487-9235. (Hablamos Español)
REFERENCES: Thermal Mapping Distribution Studies