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

The term bioburden describes the presence of microorganisms on a product, raw material, or surface. Bioburden testing has an important 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 in the US as an FDA consensus standard. This makes it the recommended way to evaluate bioburden in accordance with the EU MDR and the FDA 510(k) premarket submission process.

This example testing package includes:

• Testing of 5 identical specimens

• The presence of aerobic bacteria, facultative anaerobic bacteria, and fungi (yeasts and molds)

• Validation of the bioburden determination technique

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

• Tests under GLP

We can also offer a specific bioburden test package for your needs. Ask for a quotation and estimated turnaround time!