ARIANNA FASOLI

Dottoressa di ricerca

ciclo: XXXIII



Titolo della tesi: Rapid Microbiological Method: evaluation, validation and implementation of rapid microbiological method for pharmaceutical purpose

Pharmaceutical drug products must fulfil specified quality criteria regarding their microbial content to ensure patient safety. The main microbiological tests performed are the bioburden test, the sterility test and the endotoxin test, carried out following the traditional methods as described in the pharmacopoeia chapters. The traditional methods are limited by slow microbial growth rates, by the microbial different response to the cultural methods, by the duration of the test and in addition, the results of conventional bioburden and sterility testing methods are based on subjective evaluations of microbial growth carried out by a qualified operator. In this context the rapid microbiological methods (RMM) or alternative microbiological methods, that allow to obtain faster results, to guarantee objective results in compliance with the data integrity requirements and to increase the automation are emerged. In this work, a technology assessment for the evaluation of several rapid methods available on the market was carried out in order to identify the most suitable technologies to be implemented. The selected rapid method for the bioburden test, sterility test and bioburden test were qualified for the analysis of one or more products with the final aim to introduce the modern technologies in routine analysis.

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