Abstract
Currently, sterility testing in the pharmaceutical industry—a mandatory release test for all sterile drug products—takes an incubation time of at least 14 days and is based on liquid media according to the pharmacopoeias. The search is on for a rapid sterility test to reduce this rather long time frame. For this we have chosen the Millipore Milliflex Rapid Microbiology Detection System, which is based on solid nutrient media. As a prerequisite for the validation of this rapid sterility test, a solid nutrient medium promoting the growth of stressed and unstressed micro-organisms replacing tryptic soy broth and fluid thioglycollate medium from the traditional sterility test had to be found.
For this a wide variety of appropriate nutrient media were evaluated. After a prestudy with 10 different nutrient agar media, tryptic soy agar, Center for Disease Control (CDC) anaerobic blood agar, Schaedler blood agar, and Difco brewer anaerobic agar were tested in detail using a range of 22 micro-organisms (7 ATCC strains and 15 production site-specific strains). These strains were inoculated in their unstressed and in a stressed state. Stress was evoked by heat treatment and nutrient starvation in the case of the sporulating bacteria. This stress effect—resulting in deceleration in growth—was experimentally confirmed based on growth curve analysis. It was statistically evaluated which media and which incubation temperatures are best suitable.
The resulting data showed that Schaedler blood agar has the best growth-promoting properties among the agars tested and is going to be used in the rapid sterility test with the incubation temperatures 20–25 °C for aerobes, 30–35 °C for aerobes, and also 30–35 °C for anaerobic micro-organisms.
Footnotes
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Conflict of Interest Declaration
The authors declare that no financial or non-financial competing interests are related to the manuscript presented.
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