A Review Of sterility failure investigation fda
Test material spiked at lower levels with consultant organisms (like the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or maybe the fungus Candida albicans) are applied to ensure there is not any inhibitory result through the sample which can mask contaminants, to be a