Bioburden determination

Numerous medical devices, single-use devices or primary packaging materials in the pharmaceutical industry are subjected to sterilisation due to their intended use. For the sterilisation process to be successful, only a certain number of germs may be present on the surface of the product or the packaging. The term bioburden refers to the number of germs on the surface of a product prior to sterilisation.

Testing for bioburden is regulated in DIN ISO 11737-1 is binding for the manufacturers of medical devices.

Starting December 1, 2025, the USP will, for the first time, define clear requirements regarding bioburden with the new chapters <1119> “Bioburden Monitoring” and <1119.1> “Bioburden Test.”

These chapters apply to non-sterile, sterile, and low-bioburden manufacturing processes. Further information can be found in our news article.