Basics, methodology and significance
Bioburden determination is a central procedure for the microbiological quality control of medical devices. It is used to determine the total number of viable microorganisms (bacteria, fungi) on a product. A valid test method is essential to ensure reliable and reproducible results - especially in the context of regulatory requirements such as the MDR (EU 2017/745) and GLP. However, the necessity of validating this procedure is often questioned. In this article, we will inform you about the basics, the methodology and the importance of bioburden validation.
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