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April 2000

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Subject:
From:
Anthony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Tue, 4 Apr 2000 17:02:20 -0400
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Warren,

I see it as meeting the absence of USP indicator test using a Multipex primer for the 4 indicator organisms.  I believe that the primers you have developed are not commerically available.

In addition you can identify the predominate microorganisms in the product from the TAMC plates and/or streaking out from the enrichments if the numbers are at an alert or action limit.  Your screening on MacConkey's and Mannitol Salt Agar sounds simple and direct.  Have you submitted to the USP or plan to write a Stimuli Article?

I believe that the list of truely objectionable organisms for each pharmaceutical dosage form is relatively short.  Currently as a blue sky project we are using MALDI TOF mass spect to identify the objectionable organisms and it works well.

Tony Cundell
Wyeth-Ayerst Pharmaceutical 

>>> "Casey, Warren M" <[log in to unmask]> 04/04 9:11 AM >>>
Scott,

We have also evaluated the BAX system and can corroborate Tony's findings.
However, the major problem with a species-specific probes is that "absence"
of any given  species is not sufficent for product release (despite what the
specifications say).  We have developed a more general probe set which
attempts to get around this issue.  The probes are as follows: Gram
Negative, Staph genus, Pseudomas-like, .  Absence of these three (and
acceptable TAMC) should be enough to release the product.
Having said that, we have found that it is easier and less labor intensive
to simply streak to MCA and MSA - absence of growth on these two mediums
will accomplish essentially the same thing as the PCR probe.  This approach
takes 48 hours longer, but is  cheaper (materials) and less labor intensive.
The 48 hour difference in turn-around time is usually insignificant for our
lab - the exception being when we have GROWTH on MCA or MSA and then we
would like an ID as soon as possible (or we would like to exclude the
possibility of certain organisms being present ASAP), in which case we have
used PCR Probes and 16s Sequencing.

Warren

> -----Original Message-----
> From: Anthony Cundell [SMTP:[log in to unmask]] 
> Sent: Monday, April 03, 2000 9:02 AM
> To:   [log in to unmask] 
> Subject:      Re: [PMFLIST] PCR in Microbial Limits Testing
>
> Scott,
>
> We evaluated the BAX System (Qualicon) for Salmonella spp. and fing it
> robust and accurate. The work was conducted in collaboration with John
> Stone, Whitehall-Robins R&D
>
> We plan to extend this work as the primers for E. coli, P. aeruginosa and
> S. aureus come available and publish the work.
>
> Tont
>
> >>> Scott Sutton <[log in to unmask]> 04/03 9:00 AM >>>
> All,
>
> A general question about polymerase chain technology (PCR).  Does
> anyone know of a good probe for pseudomonads, E coli, or Salmonella?
> Is anyone using PCR in non-sterile product release?
>
> Thanks.
>
> Scott
> ---------------------
> Scott Sutton, PhD, [log in to unmask] 
> The Microbiology Network; http://microbiol.org 
> The Virtual Library: Microbiology; http://microbiol.org/vlmicro/ 
> Pharm. Microbiol. Discussion List; http://microbiol.org/PMFList_info.htm 
>
>
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