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Everything about sterility failure investigation checklist

Test substance spiked at very low degrees with consultant organisms (such as the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or the fungus Candida albicans) are utilized to make sure there is no inhibitory effect through the sample which can mask contaminants, to be

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