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July 2020

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Subject:
From:
Jayendra Shankar <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 22 Jul 2020 16:38:11 +0100
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Hi,
Does anyone have experience of using strain typing methods to support
investigations (biofilms/in-process bioburden coming through from Upstream
and persisting post inactivation stages etc.)?
Any published articles?
Any input on the awareness within regulatory circles in the use of such
methods and how it might be interpreted by an auditor will also be
appreciated.

I'm thinking MLST to show that a specific type of a certain organism that
seems to break through in post-inactivated stages are linked to organisms
seen in-process at pre-inactivated stages but at a lower number.  Review of
cleaning/sanitisation procedures etc. are ongoing.
I am also trying to show that this specific phenotypic variant is more
resistant to inactivation steps/can form biofilms - is there value in this
in front of an auditor where it could muddy the water if no causal links
are actually found! Any opinions/experience would be appreciated.

Thanks
Jay
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