Bioburden
Bioburden refers to the number of viable microorganisms present on a surface, in a product, or within a sample. It is an important measure in industries such as pharmaceuticals and medical devices, where contamination can affect product safety and efficacy. Monitoring bioburden helps ensure that products meet regulatory standards and are safe for use.
To assess bioburden, samples are collected and cultured in a laboratory to identify and quantify the microorganisms present. This process is crucial for maintaining quality control and ensuring compliance with guidelines set by organizations like the FDA and ISO. Regular bioburden testing helps prevent contamination and supports overall product integrity.