Tuesday 23 March 2021

Assessing disinfection rotation at the point of use: Designing a field trial

The qualifications required for disinfectants consist of three phases: suspension tests, surface tests and field trials. The first two phases are well-described as either European or U.S. standards, with surface testing against a range of representative surfaces being regarded as providing a more robust challenge than the suspension test. What is not described in any standard is the field trial. The field trial stands as the most important of disinfectant qualification tests for the cleanroom because it tests out disinfectants at the point of use and relates efficacy to environmental monitoring data. The field trial takes the laboratory based testing and key theoretical parameters (such as concentration and contact time) and applies these to real-life conditions. It is noted that laboratory challenge tests create a greater challenge for cleanroom disinfectants where numbers of microorganisms used are higher than those expected within a cleanroom facility. The field trial not only enables a single disinfectant to be evaluated, it also enables frequencies of application to be assessed and an assessment to be made between the rotation of two disinfectants with a different spectrum of activity and modes of action (typically, and as required by EU GMP Annex 1, rotation between a sporicide and a non-sporicide).


This article outlines an approach that can be adopted for undertaking a field trial across cleanrooms of three different grades (EU GMP Grades B, C and D). This is based on a case study using two disinfectants manufactured by Ecolab disinfectants (low residue hydrogen peroxide and low residue quaternary ammonium compound). The assessment is presented as a case study, showing how efficacy can be assessed using surface environmental monitoring together with an assessment of surviving cleanroom microorganisms.


Sandle, T. (2021) Assessing disinfection rotation at the point of use: Designing a field trial, Cleanroom Technology, 29 (3): 18-22


Link: http://content.yudu.com/web/fiqy/0A3zgsj/cleanroommar21/html/index.html?page=2&origin=reader


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

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