The
purpose of microbiological environmental monitoring is to assess the microbial quality
of the cleanroom. Most environmental monitoring is traditionally focused upon
the examination of mesophilic micro-organisms. There has been a regulatory
shift towards requesting monitoring data concerning micro-organisms with
optimal growth rates that fall outside of mesophilic conditions (what might be called
extremophiles: micro-organism requiring severe conditions for growth as defined
by extremes of temperature, pH, chemical oxidizing agents, hypersalinity or
certain types of ultraviolet light).
In
particular, regulatory agencies have enquired about the possibility of
micro-organisms that can tolerate cold conditions (psychrotolerant) or that
will only grow in cold conditions (psychrophilic) being present within cold
room environments.
To
assess this, Tim Sandle and Kerry Skinner have undertaken research to examine
the likelihood and recovery of psychrophilic and psychrotolerant
micro-organisms within pharmaceutical manufacturing environments.
The
research has been published in the Journal of
Applied Microbiology. The abstract
reads:
“Psychrophilic
micro-organisms were not detected and those considered to be psychrotolerant were
only found in low numbers. Pyschrotolerant organisms were recovered under both
low temperature incubation conditions and under standard conditions (between 20
and 35°C). Further evaluation may be required, using alternative agar, and
microbiologists should regularly review the species recovered to note
differences between different environments.”
The
reference is:
Sandle,
T. and Skinner, K. (2013). Study of psychrophilic and psychrotolerant
microorganisms isolated in cold rooms used for pharmaceutical processing, Journal
of Applied Microbiology, doi:10.1111/jam.12101
Posted by Tim Sandle
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