The Basic Principles Of sterility failure investigation checklist
Test substance spiked at minimal ranges with representative 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 a inhibitory result through the sample which may mask contaminants