A Review Of sterility failure investigation fda
Test content spiked at low degrees with agent organisms (such as the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or maybe the fungus Candida albicans) are utilised to make certain there is no inhibitory result from the sample which may mask contaminants, in order to