The sterility failure investigation checklist Diaries
Test materials spiked at small amounts with representative organisms (including the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or the fungus Candida albicans) are used to guarantee there is no inhibitory effect with the sample which can mask contaminants, as a way t