Microbial
control of pharmaceutical water systems is not only about numbers of
microorganisms estimated to be present, as recovered through bioburden testing
of a given volume of sampled water; microbiologists additionally need to know
the types of organisms present within water.
With
this a new article of interest has been published:
Marflitt,
A. and Sandle, T. (2018): Evaluation of Readycult® Coliforms 100 Presence/Absence
Test for the screening of coliforms and Escherichia coli in pharmaceutical water
samples, European Journal of Parenteral
and Pharmaceutical Science, 22 (4): 118-125
The
abstract is:
The
microbiological monitoring of water systems in pharmaceutical facilities
requires an assessment of total microbial count, with an action level
applicable to the water grade. It is also considered good practice in many
facilities to assess water for the presence/absence of identified objectionable
microorganisms. Included among these ‘objectionables’ are coliforms, as
indicators of substandard water. The traditional approach for assessing for
coliforms in water is using a specialised agar. This approach requires an
incubation time within the region of 3 to 5 days. This paper assesses an alternative
method, which provides a result within 18 to 24 hours. The method evaluated was
the Readycult® Coliforms 100, which contains both a chromogenic substrate (to
show the presence of coliforms) and a fluorogenic substrate (to show the
presence of Escherichia coli). Through a series of experimental tests involving
different grades of pharmaceutical water and different microorganisms, the
Readycult® Coliforms 100 was shown to be suitable as a rapid microbiological
method for screening water, with reactions produced comparable to conventional
methods.
Posted by Dr. Tim Sandle
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