MadgeTech Blog

Temperature Studies: What is Temperature Validation?

What is Temperature Validation? Posted on

When it comes to long-term temperature monitoring or short-term temperature studies, there are a lot of terms that can be thrown around. This series of blog posts is meant to shed some light on these different terms and break down their meanings.

To read section one on temperature qualification, click here.
To read section two on temperature maping, click here.

What is temperature validation?

To validate something is to check or prove the accuracy of something. As I learned in Algebra, the proof is as important as the answer. Show how you came to the final answer to prove that the processes are suitable. In a temperature validation study or report, demonstrate that the environment is proven to satisfy the set of standards based upon the industry requirements. The data supports the methods of testing which tells the story of how the instrument or environment came to meet the standards.

Verifying that equipment and storage facilities meet basic temperature requirements is a fundamental component of a thermal mapping process. By providing evidence of the temperature within a controlled area, the overall process begins on stable ground. A validation is the collection and evaluation of data to establish scientific evidence that an instrument or area is capable of consistently maintaining and quality product.

A process that requires machines to provide consistent results should include temperature verification records. These records include the expected and acceptable outcomes to be delivered repeatedly. To consistently ensure that a system produces repeatable results, test the equipment, and document the results. Perform various tests on equipment under highly controlled conditions. Establish processes, methods, and systems which consistently produce results that meet pre-determined acceptance criteria.

The goal is to confirm the process meets expectations and can reproduce the results. The types of equipment used varies with each industry but a common system that enables operations is the structure in which they perform daily production. Knowing the median temperature in R&D, laboratories, conference rooms, and storage facilities seems rudimentary but is the basis for a solid foundation.

What equipment provides the data for the Validation Report?

To show that an autoclave is in proper working condition, employ 5-9 HiTemp140 data loggers throughout the small space. Each corner, the middle, and possibly alternate shelves should be checked for uniformity and consistency. In an environment with a wide range of acceptable temperatures that covers a lot of space, users may employ the Temp101A data logger.

Whichever logger is chosen for the application should help to tell the story of a validation process. The process begins with a stable environment that has been compared to an acceptable high-level standard and ends with a document that proves temperature control is in place.

For more information about how MadgeTech data loggers can help simplify temperature monitoring procedures, call us at (603) 456-2011 or email [email protected].

About Shane Belanger:

Shane joined the MadgeTech team in 2017 taking on technical support issues. Since then, Shane has acquired a wealth of knowledge and transitioned to sales where he applies his understanding of our products and services to help find customers the best data logging solution for their applications.