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April 2000

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Subject:
From:
"Lee, Lucy" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 6 Apr 2000 12:07:05 -0400
Content-Type:
text/plain
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text/plain (183 lines)
You are right about the search for the famous " four " sometimes yields
other objectionable organisms.  I can tell you that I once tested an unusual
final product form that yielded an organisms that consistently gave an ID
for Shigella.  This organisms showed up in samples from different lots on
numerous occasions.  The company requested that we remove this information
from the final report as it was "confusing and irrelevant.  After all, it
wasn't one of the four indicator organisms."  We tried to get them to
understand the significance of finding Shigella.  I don't recall we were
successful.  They pulled their testing from our lab.  Shortly after this the
product disappeared from the market.  Good riddance.

> -----Original Message-----
> From: Casey, Warren M [SMTP:[log in to unmask]]
> Sent: Wednesday, April 05, 2000 7:45 PM
> To:   [log in to unmask]
> Subject:      Re: [PMFLIST] PCR in Microbial Limits Testing
>
> Tony,
>
> The way in which "objectionable" organims is defined can be a tricky
> issue.
> There have been MANY products recalled for the presence of organisms other
> than "The big four" (keep in mind that E. coli and Salmonella  have never
> been found (reported) in a synthetic phama product manufactured under
> GMPs).
>
>
> We have just finished our last round of studies to support the method I
> mentioned, I will be submitting it for a stimuli article in the next
> couple
> of weeks.  It is not only equilent to the USP method - it is far superior.
>
> Some of the primers we used were from published reports, and some of them
> were designed by Heidi Muth using published sequence data. The details of
> the primer/probe design will be outlined in a papper we are submiting  to
> J.
> Clinical Micro on the rapid ID and screeing of bacteria using a new
> fluorescent technology.
>
> Warren
> > -----Original Message-----
> > From: Anthony Cundell [SMTP:[log in to unmask]]
> > Sent: Tuesday, April 04, 2000 5:02 PM
> > To:   [log in to unmask]
> > Subject:      Re: [PMFLIST] PCR in Microbial Limits Testing
> >
> > 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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> >
> >
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> >
> >
>
>
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> The Microbiology Network (http://microbiol.org) and supported by
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