sterility failure investigation fda - An Overview
Test materials spiked at small levels with consultant 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 be sure there isn't any inhibitory result within the sample which may mask contaminants, as