Back to Sterility Testing

Each sterility test should be qualified by a bacteriostasis and fungistasis (B&F) test. The B&F test demonstrates that the test article itself is not inhibitory to the growth of microbial contaminants that can be present in the test sample. This assay must reflect the actual sterility test methodology that will be used on the sample. Therefore, it is important first to determine how the sterility test is intended to be conducted and then to design the B&F test to support the intended sterility test methodology. If bacteriostasis or fungistasis is observed during the conduct of the B&F test, adjustments to the testing methodology are made to eliminate, if possible, the cause of the stasis.