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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Pharmaceutical Microbiology Resources