Application Note: Examination of non-sterile products: tests for specified microorganisms
For certain product types, there is a requirement for testing to determine the absence of certain microorganisms…
These specified microorganisms include pathogens and are known as indicator microorganisms. This is due to the fact that they may indicate the presence of other microorganisms from similar sources that are known to be hazardous for immunocompromised and other high-risk patients.
There are a number of microorganisms that are tested for, including the following:
Escherichia coli is a natural inhabitant of the gut flora and part of the Enterobacteriaceae family. Some species are pathogenic and cause diarrhoea. E. coli’s presence in water, raw material and products indicates faecal contamination and it is listed as an organism of concern for oral products.