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November 2019

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Subject:
From:
Reuven Baum <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sun, 10 Nov 2019 21:26:31 +0200
Content-Type:
text/plain
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I am doing a direct inoculation sterility test.
The test only contains a small volume. I expect to dilute the sample with
Fluid A  and will  transfer half the volume (total of 1 mL) to TSB and FTM.
The batch is so small that only one production vial is tested.
Do i need a negative control? If yes what is it?
I already performed sterility and growth test on receiving the TSB/FTM.


Reuven
QC Microbiologist
Yavne

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