Bioburden, the population of viable microorganisms found on a medical device, pharmaceutical raw material, or product prior to sterilization; is a critical parameter in medical device manufacturing. Determining the precise bioburden is essential for validating sterilization processes, ensuring product safety, and complying with stringent regulatory standards. The "best" testing method is not a one-size-fits-all solution; rather, it is a strategic choice based on the sample’s

In the medical device industry, maintaining high standards of quality is a necessity. Among the various components of quality assurance,...