In this article, you will learn 4 simple instructions to make a thermal mapping distribution study using Temperature Data Loggers for environmental monitoring and other validation studies in Puerto Rico. Moreover, you can find out how to get a thermal mapping validation template and validation management software application to handle your qualification activities fast and easily.
A thermal mapping consist of the following four broad activities:
1. Protocol development.
Prepare the validation protocol which describes the instruction to follow during the thermal mapping distribution study. Optionally, you can create your validation protocol(s) using a CIQA protocol template to accelerate the process of preparation and approval.
2. Trial execution.
Get the temperature data loggers and installed in each different location to be monitored during the thermal study. Make sure the data loggers are calibrated. Once completed the study, remove the data loggers and extract the information for analysis, trending, and statistical reporting preparation. This is the most critical part since you shall need to buy or rent the temperature data loggers necessary for your study.
3. Data analysis.
Perform the data evaluation and tabulation to calculate the average, maximums, and minimums values and locations. Also, prepare the trending plots and graphs showing the behavior of the environmental conditions during the validation study.
Once completed the data analysis, prepare a summary report which summarizes the results, statistics and graphs to support the conclusions and recommendations of each monitored location.
CIQA can bring you these services, as well as the rental of the data loggers to make the monitoring.
Thermal studies require the use of very expensive validation instrumentation and equipment, which represent a high cost in many cases if the utilization of that equipment is very low.
Since some companies do not have the internal personnel with the experience and knowledge to perform these studies, they contract third-party companies as CIQA Engineering to make that work.
CIQA Engineering has the equipment and experienced professionals to perform the thermal mapping and qualifications. We can prepare the protocols, bring the measurement instruments for monitoring, make the analysis and reporting documents once the data is gathered.
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
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 A THERMAL MAPPING, FEEL FREE TO CONTACT US EITHER BY EMAIL OR PHONE: 787-487-9235. (Hablamos Español)
REFERENCES: Make a Thermal Mapping