sterility failure investigation fda - An Overview
Test substance spiked at very low amounts with agent organisms (such as the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or perhaps the fungus Candida albicans) are made use of to ensure there is not any inhibitory influence with the sample which may mask contaminants