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.
For further details, contact Tim Sandle
Posted by Dr. Tim Sandle