A Review Of sterility failure investigation fda
Test substance spiked at small stages with consultant organisms (such as the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or perhaps the fungus Candida albicans) are utilised to make sure there isn't any inhibitory outcome from your sample which can mask contaminants,