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May 2020


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Michael Barton <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Fri, 22 May 2020 10:49:48 +0000
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Hi All,
if the product is ~200ul contained within an assembled device how do you perform the AET test?
The device will need to be completely disassembled to get to the internal liquid (200ul) contained within a small vial in the center of the device.

Im assuming that this volume is too small to perform tetsing on as the inoculum volume of each organism will completely dilute the formulation.
What volume do you need to use and how do you justify that or do you just need to show that your inoculum is between 1.0x10^5 to 1.0x10^6  per ml of product solution?

Do you need to have representative containers manufactured to be the same material as what is in contact with the solution within the device?
What about any closure/stopper in the device as this is small and specificaly tooled to fit and probably not able to get a larger one made for the purpose of AET testing.

Thanks as always

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