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Andrew Middleton - Articles and news items
The increasing use of Microbial Genotypic Techniques for the Identification of Pharmaceutical Isolates
The historical demarcation of prokaryotes has not been by way of a specific scientific-based concept, but has been defined by a more arbitrary, anthropocentric system, rooted in the practical necessity of the time of its inception, based on the information available at the time. Therefore, species are historically defined on the basis of the disease they cause.
Issue 6 2007 / 23 November 2007 /
In order to meet the challenges demanded by the requirements of Process Analytical Technology (PAT), the modern microbiological laboratory needs to become more innovative in microbial detection, identification and enumeration. Technology is becoming available that will speed up microbiological analysis, potentially allowing pharmaceutical microbiology tests to get as close as is possible to the concepts of PAT. Following on from the article by Bob Johnson1, this article explores the future technologies in greater detail.
Subsequent to the publication of the PDA technical Report Number 33 in 20001 there has been a multitude of articles published in pharmaceutical reviews and commentaries with regard to rapid microbial methods (RMM). The majority of these articles cover, to a greater or lesser degree, the technologies available and summaries of the requirements for validation, implementation and regulatory acceptance. There have also been some articles that have explored the potential reasons for the relatively slow uptake of alternative microbiological testing methods. While these articles address valid issues, few explore in detail the further possibility for the slow uptake; the appropriateness of the currently available RMM technologies.
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