Detailed Notes on sterility test failure investigation
Test content spiked at small stages with representative organisms (like the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or the fungus Candida albicans) are applied to be sure there's no inhibitory influence in the sample which can mask contaminants, so as to validate