Not known Details About sterility test failure investigation
Test product spiked at minimal ranges with agent organisms (like the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or the fungus Candida albicans) are utilized to ensure there is no inhibitory result through the sample which may mask contaminants, in an effort to valid