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Test materials spiked at minimal amounts with representative organisms (including the aerobic bacterium Staphylococcus aureus, spore forming bacterium Bacillus subtilis, anaerobic bacterium Clostridium sporogenes or perhaps the fungus Candida albicans) are utilised to be certain there is absolutely no inhibitory influence from the sample which may

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In pharmaceutical practice, a container is defined as sterile once the probability is fewer than one out of one million that it's contaminated with replicating microorganisms. Because it is impossible to open and test Every container of a biological medicinal products, a variety of samples, consultant with the lot staying tested and taken at differ

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