Thermal Mapping Distribution Tests during Validations in Puerto Rico.

THERMAL MAPPING DISTRIBUTION TESTS

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 RicoAlso, you learn how to get a thermal mapping validation template and validation management software application to handle your qualification activities fast and easily.

What 5 Tests are Recommended During a Thermal Mapping?

The different tests can be done during thermal mapping depending on the intention and purpose of the area to be monitored.

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. 

TEMPERATURE AND % RELATIVE HUMIDITY DATA LOGGERS RENTAL

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. 

Contact us to get more information about services to make the initial setup, configuration, and statistical summary reports with trending graphs. 

 Click here to Request a Custom Quotation online to Rental calibrated temperature and humidity data loggers

cGMP VALIDATION & REGULATORY COMPLIANCE CONSULTING
STAFFING AGENCY

FOR MORE INFORMATION ABOUT STAFFING AGENCY SERVICES TO PERFORM YOUR VALIDATIONS AND IMPLEMENT YOUR SOFTWARE APPLICATIONS. 

VALIDATION MANAGEMENT SOFTWARE APPLICATION

Moreover, soon you can get a Validation Management Software Application to handle all your qualification and validation protocols and report documents from anywhere at any time.  Subscribe to learn more about our free validation management software application.


 

MORE SERIES AND VIDEOS ABOUT TEMPERATURE DATA LOGGERS

 TO RECEIVE NEWS AND USEFUL TOOLS ABOUT THE DIFFERENCES BETWEEN TEMPERATURE DATA LOGGERS, SUBSCRIBE, AND FOLLOW US.



 brought to you by CIQA-thermal Mapping Distribution Studies

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

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  1. What is a Temperature Data Logger?
  2. The 12 Most Common Applications for Temperature Data Loggers.
  3. The Top 6 Advantages Using Temperature Data Loggers
  4. The 5 Most Common Types of Temperature Data Loggers
  5. The Top 10 Main Characteristics of the Temperature Data loggers
  6. The 4 Main Attributes of Temperature Data loggers.
  7. Costs of the Temperature Data Loggers for Validation Purposes
  8. The 4 Best Features of the Temperature Data Loggers
  9. The Top 3 Pros and Cons of Temperature Dataloggers
  10. The 5 Most Common Uses of the Temperature Data loggers
  11. How to Determine the Data Loggers Record Duration?
  12. How to Download the Information out of the Temperature Data Logger
  13. How to Determine the Number of Temperature Data Loggers Do I Need?
  14. How Data loggers can handle their memory.
  15. The Top 6 Reasons Why People Rent Temperature Data Loggers.
  16. 3 Reasons Why are Temperature Data Loggers Useful.
  17. How to Configure a temperature Data logger in 5 steps
  18. The 5 Most Common Mistakes When Buying Data Loggers
  19. How to Choose the Best Temperature Data Loggers for your Validation.
  20. 6 Main Differences between Data Loggers.
  21. What is a Thermal Mapping Distribution Study?
  22. How to Make a Thermal Mapping in Four Steps
  23. What 5 Tests Should Be Performed During Temperature Mapping?
  24. Understanding the 5 Most Relevant Thermal Mapping Outcomes
  25. The Best Locations to Place Temperature Data loggers for thermal mappings.

Samples Documents

https://ciqa.net/wp-content/uploads/2021/08/CIQA-Thermal-Mapping-Protocol-Template-Sample-Version.pdf

Ecommerce

https://ciqa.net/validation-protocol-templates/

https://ciqa.net/thermal-mapping-protocol-template/

https://ciqa.net/product/validation-management-software-application/

https://ciqa.net/product/temperature-data-loggers-rental-puerto-rico/

https://ciqa.net/product/thermal-mapping-protocol-template/

Amazon

httpss://www.amazon.com/dp/B09FNGP1ZF

httpss://www.amazon.com/dp/B09FNJY2QZ

httpss://www.amazon.com/dp/B09FKR1BPL

httpss://www.amazon.com/dp/B09FC3S361

httpss://www.amazon.com/dp/B09FHG77R9

httpss://www.amazon.com/dp/B09FC9ZB6D

Youtube

httpss://youtu.be/t60zspzgenw – Ep1 -old

httpss://youtu.be/Y40247ctXw0 – Ep1

httpss://youtu.be/H58OKuwg6Cc – Ep27 software

httpss://youtu.be/YxrzxgN0R5o –  Ep26 template

httpss://youtu.be/8-uQ5yK5LvQ – Ep2

httpss://youtu.be/reOOwY0XoiU  -Ep3

httpss://youtu.be/xKfQcdOZFyo – EP4

httpss://youtu.be/b_vr8uTlyaY – Ep5

httpss://youtu.be/MKrmP3EGhG4  -Ep6 – old

httpss://youtu.be/6bxqjiHCoEo – Ep6

httpss://youtu.be/EkKHZeNx-FM  -Ep7

httpss://youtu.be/FI9aJMojg5I  -Ep8

httpss://youtu.be/i4vOf0nzpL0 – Ep9

httpss://youtu.be/J82Q3H9c0IE – Ep10 Differences between data loggers

httpss://youtu.be/PuEfgrOdm4I – Ep11

httpss://youtu.be/oeaWhumdi5A – Ep12

httpss://youtu.be/3p7Q8jHkAUA –  Ep13

httpss://youtu.be/GDf_pB4opbE – EP14

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!