The Ultimate Guide To sterility failure investigation checklist
Test product spiked at reduced ranges with representative organisms (such as the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or the fungus Candida albicans) are made use of to ensure there isn't any inhibitory outcome from your sample which may mask contaminants, in