Thermal validation - a complete guide
When storing temperature-sensitive goods, e.g., medicines, tissue samples, or vaccines, it is crucial to test and document that your refrigeration and freezing equipment are able to maintain temperatures within the required range.
For this purpose, a thermal validation is performed, which proves that the equipment complies with the criteria set by authorities and auditors. If the study shows that the equipment does not meet the criteria, the equipment is calibrated or fixed and a new study is conducted. In addition, you become aware of areas that are too hot or too cold to be used, e.g., close to the door or the back of the cooling equipment.
Last but not least, it will provide you with information on where to place your temperature monitoring equipment to make sure that you receive an alarm immediately if temperatures are above or below the required temperature range.
Inside a fridge, temperatures can fluctuate by several degrees. The temperature in your kitchen fridge e.g., can vary by as much as 5 degrees from the top to the bottom. The same principle applies to industrial fridges and freezers, which is why it is paramount to perform a thermal validation of your new equipment before it is put into use.
Thermal validation of refrigeration equipment with Eupry’s Kit
Save time by using Eupry’s easy-to-use kit with accredited DANAK ISO17025 calibration and 21CFR PART11 compliance. Thermal validation of cooling equipment is an important process when examining whether your equipment is working properly.
Practical mobile box with the numbers of data loggers (temperature sensors) needed.
Base Station & Batteries
A wireless base station and extra batteries.
All data loggers are START calibrated, and an END calibration is performed.
eBook - What is Temperature Mapping?
Read our eBook and get introduced to the basics of temperature mapping. We will give you a good overall idea of how to perform a professional mapping of your equipment.
Recommendations on validation equipment and software
A thermal validation study is quite simple if you have the right equipment. We recommend using wireless dataloggers that automatically sends all data to a server, where it can afterwards be easily analyzed in an app or web browser. Here it is also important that you are able to export reports within specific time periods if e.g., an auditor requests the information. Overall, great validation software can reduce time spent on execution, data analysis, and report generation.
Eupry’s online documentation system, the Eupry Logger, excels in ease of use and security. Temperature data logs are illustrated in graphs and data can be exported in the approved PDF-format. You are also able to easily find documentation for recent calibrations and manage data logs in multiple locations. All data are stored in ISO9001 / ISO27001 certified environment.
The level of difficulty of the installation process is worth considering. If it requires technical expertise you might end up spending valuable time figuring it out or end up having to hire a technical consultant.
Eupry’s WiFi data loggers are shipped by mail to your location. The installation process is easy and requires no prior technical knowledge. We have a comprehensive set of guides to help you get up and running. If you encounter problems, our support center and staff are always happy to help.
It is important to check that dataloggers are calibrated and come with a certificate documenting that they are calibrated within a reasonable limit and timespan. Typically, 0.5C precision and a maximum calibration interval of 1 year will be sufficient.
When using Eupry’s dataloggers, you can choose to have the wireless dataloggers calibrated in our ISO 17025 accredited laboratory or via traceable 3-point calibration. As part of Eupry’s service, new calibrated data loggers are shipped annually to your address. The old data loggers are afterwards simply replaced with the new ones and sent back to us. The annual calibration is included in Eupry’s service.
The battery lifetime of the data loggers is a simple but crucial element. You do not want to experience that batteries are depleted during the validation study. Eupry’s dataloggers has a battery lifetime of 2 years and since they are replaced once a year, the battery lifetime never becomes an issue.
If you need help in connection with setting up the dataloggers or completing the thermal validation study, it can be a great advantage to be able to get support. Eupry has a dedicated online support center as well as fully trained staff available to call or email whenever you need help. If allowed by the user, Eupry’s staff can also look at your system and assist you with the installation and configuration process.
FDA 21 CFR Part 11
It is recommended to comply with 21 CFR PART 11 if you operate in the US. market within industries such as drugs & medicine, food or tobacco. 21 CFR PART 11 refers to the regulations set forth by the FDA regarding electronic records and electronic signatures. The purpose of the regulation is to ensure that electronic records can be trusted in the same way that handwritten records and signatures on paper are trusted.
Eupry’s solution comes with both accredited DANAK ISO17025 calibration and 21CFR PART11 compliance.
Next step – Thermal validation
We have now covered a list of recommendations on what equipment and software to use when performing a thermal validation study. The next step is to actually complete the study. Read our guide on which provides you all the information you need.
You will also find tips on how to complete a thermal validation / temperature mapping study in cold rooms, freezers, fridges, warehouses and storage areas. Additionally, you will find a FAQ section with answers to the most common questions that arise when conducting a thermal validation / temperature mapping study.
When you have completed the thermal validation study, you will have located the hottest and coldest areas, which will be of interest since the risk of temperature deviations during normal use is high in these areas.
If you have located areas unsuitable for temperature sensitive items, we recommend marking those areas with tape. Simultaneously, you can note which areas that are within the temperature limits and thus can be used for storing critical goods.
When choosing the equipment for monitoring temperatures, it is especially advantageous to use a temperature monitoring system with an alarm function, that notifies you immediately if the equipment fails or does not work properly. This way deviations can be discovered immediately, which will save valuable goods.