Bioburden testing by ISO 11737-1, aerobic bacteria and fungi

The term bioburden describes the presence of microorganisms on a product, raw material, or surface. Bioburden testing plays a crucial role in the quality control of medical devices, pharmaceutical products, and their components.

This analysis follows the ISO 11737-1 standard to detect populations of viable microorganisms on a product before sterilization, thus indicating the microbiological cleanliness of the product.

ISO 11737-1 is recognized in the EU as a harmonized medical device standard and by the FDA as a consensus standard. This makes it the recommended way to evaluate bioburden under the EU MDR and the FDA 510(k) premarket submission process.

This example testing package includes the following:

• Testing of 5 identical specimens

• Detecting the presence of aerobic bacteria and and fungi (yeasts and molds)

• Validating the bioburden determination technique

• Results expressed as total CFU/test product (CFU=colony forming units)

• Tests under GLP

We can also offer a custom bioburden test package for your needs, especially for large sample volumes. Please ask our experts for a quotation and estimated turnaround time.