Myeong Braga*
Through patient contact, medical devices provide critical care and diagnostic applications. The probability that a single viable microorganism will be present on an item following a sterilization procedure is known as the sterility assurance level (SAL). Utilizing conventional laboratory-based culture media for enumeration, sterilization microbiology frequently relies on an overkill validation strategy that results in a 12-log reduction in the population of recalcitrant bacterial endospores. Sterilization microbiology relies heavily on conventional culture-based methods, which are the subject of this timely review. The inability to fully comprehend the inactivation kinetics of a sterilization process like vaporized hydrogen peroxide (VH2O2) sterilization and, as a result, to design effective sterilization procedures is taken into consideration. Real-time flow cytometry (FCM) is used in a specific way to explain the practical relevance of these limitations, as well as the ramifications and opportunities for the sterilization sector. Realtime kinetic inactivation modeling will be informed by the application of FCM to these culture-based limitation factors, allowing the pharmaceutical, medical device, and sterilization industries to take advantage of emerging opportunities, including potentially disruptive applications requiring less sterilant use.
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