Not known Factual Statements About sterility failure investigation checklist
Test product spiked at reduced levels with representative organisms (like the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or perhaps the fungus Candida albicans) are made use of to guarantee there is absolutely no inhibitory influence from the sample which can mask c