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July 2020


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David Jones <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Tue, 28 Jul 2020 15:34:09 +0000
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We have a product that is being tested for "final product sterility" so the product is incubated for 7 days then tested for contamination. The issue is that the product develops a positive pressure inside its container so can create an aerosol as it depressurizes on opening. We are looking to perform growth promotion testing with the standard USP organisms so we anticipate A brasiliensis will have developed spores that may be released into the BSC on opening the container.
Our assumption is that the release of spores into the BSC is not desirable so we are looking for ways to address the issue and perform the test. Has anyone come across this issue and found a way around it?


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