Monday, 5 October 2020

Putting disinfectant to the test: Designing a field trial


The final stage of disinfectant efficacy testing is the field trial. This is where the disinfectant(s) under qualification are studied during in-use conditions in facility cleanrooms. As disinfectants are used in rotation and they are affected by different factors, all variables need to be captured in the field trial. The challenge for many users is that the field trial has not been standardised (there is no European standard in existence, for example). Nevertheless, the importance of field trials is referenced as part of the hierarchy of European Standards (phase I basic screening [suspension] tests, phase II suspension and surface tests, phase III field trials) and in USP General Chapter of Disinfectants and Antiseptics <1072>. This reference means that conducting a disinfectant field trial is a regulatory expectation.

In relation to this, Tim Sandle has written an article:
Sandle, T. (2020) Putting disinfectant to the test: Designing a field trial, Cleanroom Technology, June 2020 at: https://www.cleanroomtechnology.com/news/article_page/Putting_disinfectant_to_the_test_Designing_a_field_trial/166799


The disinfectant field trial represents the final step in the disinfectant qualification process and it is the most important, as the exercise provides real-world data to support the efficacy of disinfection within the facility - something that is assessed within the user's cleanrooms, using locally determined techniques and frequencies, and as assessed against the typical microorganisms unique to the facility. This article has presented why the field trial is important and some of the key aspects to consider.

For further details, please contact Tim Sandle.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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