The Basic Principles Of sterility failure investigation checklist
Test material spiked at very low levels with agent organisms (including the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or even the fungus Candida albicans) are utilised to be sure there isn't any inhibitory result with the sample which may mask contaminants, so that