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 and detects 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, which means that if the test is passed, the device can be presumed to conform with Regulation (EU) 2017/745 with regard to bioburden. The standard is also accepted by the FDA as a consensus standard, making it a recommended way to evaluate bioburden during the 510(k) 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 are given 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!