Monday 27 November 2017

The people factor: investigating the gown

An effective environmental monitoring programme is designed to estimate the microbial content of the room air and surfaces (by incident rate, against alert and action levels, and by assessment of different species) for operations performed within a cleanroom or controlled environment. While individual results are rarely of significance, a well-designed environmental monitoring programme signals conditions contributing to rises in microbial levels. Shifts in microbial trends can be due to ineffective cleaning, disinfection, faulty air handling systems, material and equipment transfer, and the result of personnel related issues. With this latter point the majority of contaminants dispersed into cleanrooms derived from personnel.

Based on this, Tim Sandle has undertaken a review of cleanroom gowns, gown use and gown locations, in relation to microbial contamination. The detection of contamination on the gown either indicates a concern with the practices of an individual operator or a problem with the gown itself. The paper looks at several aspects of gown wearing through a review of data collated over a one year period. The data was studied for four considerations:

Locations most likely to indicate contamination.
Differences between re-laundered and single-use gowns.
Variations of gowns when re-laundered.
Variations in efficiency of gowns when worn over time.

The reference of the paper is:

Sandle, T. (2017) The people factor: investigating the gown, European Pharmaceutical Review, 22 (4): 23-26

For further details, please contact TimSandle

Posted by Dr. Tim Sandle

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