Examine This Report on sterility failure investigation fda
Test materials spiked at lower concentrations with consultant organisms (including the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or the fungus Candida albicans) are used to guarantee there isn't any inhibitory effect with the sample which can mask contaminants, in