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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 9 Jul 2020 20:31:06 -0400
Content-Type:
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Tim do not set the bar too high. TSB incubated aerobically is not that
suitable for the recovery of C. acnes. Also the skin microbiota does not
grow well at 20-25 degree C.

On Thu, Jul 9, 2020, 7:03 PM Timothy Cser <[log in to unmask]>
wrote:

> Hi Reuben.  I think you probably need to create your internal
> justification.  Was this mandated by a regulator?  If so, you should
> probably ask why.  Was there an organism or set of organisms you can’t
> recover?
>
> Using two temperatures is very common so that’s not an issue. You’d
> probably need to show you can recover something like Cutibacterium acnes
> (previously Propionibacterium acnes) in addition to the 5 classical USP
> organisms.  That’s just one example, you may choose other relevant
> environmental samples but I know C acnes is one of the more difficult to
> recover EM contaminants.
>
> Tim Cser
> MilliporeSigma
> MilliporeSigma is a division of Merck KGaA, Darmstadt, Germany
>
>
> > On Jul 9, 2020, at 6:53 AM, Reuven Baum <[log in to unmask]> wrote:
> >
> > We previously incubated media fills at 20-25C for 14 days.
> > We intend to change to 20-25C for 7 days followed by 30-35C for 7 days.
> >
> > What level of justification is needed for this change ?
> > Is a risk assessment enough ?
> > Do we need to do a study with microorganisms  ?
> >
> >
> > Reuven
> > QC Microbiologist
> > Isotopia
> >
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Steris - http://www.sterislifesciences.com/

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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