Everything about sterility failure investigation checklist
Test product spiked at reduced stages with consultant organisms (such as the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or perhaps the fungus Candida albicans) are applied to be sure there isn't a inhibitory impact in the sample which can mask contaminants, so that