In this article, you will learn the 5 most common thermal mapping distribution tests done using Temperature Data Loggers for environmental monitoring and other validation studies in Puerto Rico. Also, you learn how to get a thermal mapping validation template and validation management software application to handle your qualification activities fast and easily.
The Top 5 Testing Performed During Thermal Mappings Include:
1. Empty Chamber Thermal Distribution. thermal mapping distribution tests
This test is done with the chamber and equipment without any load or product inside to determine its behavior and response with no material on it. A pre-determined amount of temperature and relative humidity data loggers shall be installed inside the equipment to collect the information on each sampling location established.
2. Loaded Chamber Thermal Penetration. thermal mapping distribution tests
This test is done with the chamber and equipment fully loaded with the product inside to determine its behavior and response with the whole amount of material on it. In the same way, calibrated data loggers shall be placed inside the equipment to measure and monitor the environmental conditions on each sampling location.
3. Open Door Challenge. thermal mapping distribution tests
This test shall verify if the equipment is capable to maintain the temperature and relative humidity conditions during a pre-determined period of time once the door is opened.
4. Power Outage Study.
This test shall verify if the equipment is capable to maintain the temperature and relative humidity conditions during a power failure or power outage of a pre-determined period of time.
5. Power Off Test. thermal mapping distribution tests
This test shall verify if the equipment is capable to maintain the temperature and relative humidity conditions during a power off or power shutdown of a pre-determined period of time.
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.
VALIDATION PROTOCOL TEMPLATES
GET THERMAL MAPPING AND VALIDATION PROTOCOL TEMPLATES
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.
Now you can download a complete validation protocol template fully editable in MS Word or get a hard-copy and Amazon Kindle format, ready to fill, and use according to your cGMP needs, check the following documents and see more information at the CIQA Shop.
DATA LOGGERS SETUP AND CONFIGURATION SERVICES:
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.
cGMP VALIDATION & REGULATORY COMPLIANCE CONSULTING
VALIDATION MANAGEMENT SOFTWARE APPLICATION
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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.
- What is a Temperature Data Logger?
- The 12 Most Common Applications for Temperature Data Loggers.
- The Top 6 Advantages Using Temperature Data Loggers
- The 5 Most Common Types of Temperature Data Loggers
- The Top 10 Main Characteristics of the Temperature Data loggers
- The 4 Main Attributes of Temperature Data loggers.
- Costs of the Temperature Data Loggers for Validation Purposes
- The 4 Best Features of the Temperature Data Loggers
- The Top 3 Pros and Cons of Temperature Dataloggers
- The 5 Most Common Uses of the Temperature Data loggers
- How to Determine the Data Loggers Record Duration?
- How to Download the Information out of the Temperature Data Logger
- How to Determine the Number of Temperature Data Loggers Do I Need?
- How Data loggers can handle their memory.
- The Top 6 Reasons Why People Rent Temperature Data Loggers.
- 3 Reasons Why are Temperature Data Loggers Useful.
- How to Configure a temperature Data logger in 5 steps
- The 5 Most Common Mistakes When Buying Data Loggers
- How to Choose the Best Temperature Data Loggers for your Validation.
- 6 Main Differences between Data Loggers.
- What is a Thermal Mapping Distribution Study?
- How to Make a Thermal Mapping in Four Steps
- What 5 Tests Should Be Performed During Temperature Mapping?
- Understanding the 5 Most Relevant Thermal Mapping Outcomes
- The Best Locations to Place Temperature Data loggers for thermal mappings.
https://youtu.be/H58OKuwg6Cc – Ep27 software
https://youtu.be/YxrzxgN0R5o – Ep26 template
https://youtu.be/MKrmP3EGhG4 -Ep6 – old
https://youtu.be/J82Q3H9c0IE – Ep10 Differences between data loggers
https://youtu.be/PuEfgrOdm4I – Ep11
https://youtu.be/oeaWhumdi5A – Ep12
https://youtu.be/3p7Q8jHkAUA – Ep13
https://youtu.be/GDf_pB4opbE – EP14