Dear all,
I have a short question for you;
When conducting validation/verification of sterility test method (membrane filtration for example), it is important to test the suitability of the method to the tested matrix using the maximal volume of matrix you will eventually be using during the analytical test itself.
My question is, do you need to do that for bioburden test as well? I mean, EMA states that pre-filtration bioburden limit should not exceed 10 CFU/100mL; so if I am to perform method suitability test, do I have to use 100 mL sample for each bacterial strain?
Thanks for you help,
A. Levi.