Microbiological inspections of different medical devices

The microbiological quality control represents a cornerstone in the production process of pharmaceutical products and Medical Devices (MDs). In both the pharmaceutical and MD industries, along with evolving regulatory requirements, products of greater complexity are elevating the challenges related to maintaining microbiological integrity. For a given inactivation treatment, the probability of bacterial survival is determined by number and resistance of microorganisms and by the environment in which the organisms live. Nevertheless, the sterility of an individual item in a population of sanitized products cannot be ensured in the absolute sense.