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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:
Wed, 22 Jul 2020 09:43:30 -0400
Content-Type:
text/plain
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Don you and other members of the PMF should be aware that the USP
Microbiology Expert Committee is not responsible for water chapters and
monographs.

On Wed, Jul 22, 2020, 9:11 AM Donald English <[log in to unmask]>
wrote:

> Dear Tony,
>
> I'm in agreement with your statement that tablets should not be tested for
> the presence of Burkholderia cepacia complex.
>
> For most aqueous non-sterile product formulations that have the presence of
> Burkholderia cepacia complex, the water that is used to manufacture the
> product is the likely source of the contamination.
>
> In your posting, you had stated that the expert committee was aware that
> companies may use the test for water
> monitoring and added the caution suggesting dilution of the
> enrichment broth may be necessary to recover Bcc. No endorsement of this
> monitoring should be implied.
>
> I would have not included the statement in the chapter as an option and
> just leave it for non-sterile aqueous and inhalation product formulations.
> If the USP expert committee has a concern about Burkholderia cepacia
> complex in the water that is used for aqueous non-sterile product
> formulations  it would have been more appropriate for the USP expert
> committee to develop an actual microbial test chapter for purified water
> instead that is not a guidance chapter.  Most of the microbial test methods
> that are used for the microbial analysis of water comes from Standard
> Methods for the Examination of Water and Wastewater.  In this book, there
> is no enrichment test method for detecting the presence of Burkholderia
> cepacia complex in water samples.
>
> Before this chapter had been issued, I would think that it was not a common
> practice to conduct enrichment testing on purified water samples.  If
> identification is done, it is performed on microbial colonies that are
> present on the pour or membrane filtration recovery plate.  Furthermore, I
> would tend to believe that most people did not test their purified water
> samples for the presence of Burkholderia cepacia complex by
> conducting identification on recovered isolates unless the microbial counts
> were above the alert and action levels for a water system.
>
> If the USP expert committee has a concern about the presence of
> Burkholderia cepacia complex in purified water system for non-sterile
> aqueous products which is justified from my perspective, make it a
> requirement that speciation be conducted on representative colonies from
> recovery plates in a purified water microbial testing chapter instead of
> placing this vague statement in the chapter for detecting the presence of
> Burkholderia cepacia complex in aqueous finished products that it is
> optional for pharmaceutical grade water.  In addition, this purified
> water microbial testing chapter should not be a guidance chapter because
> the information in it is not requirement.  If such a requirement was put in
> place for identification of all recovered colonies on all purified water
> samples no matter what was the count, it might cut down the number of
> product recalls due to Burkholderia cepacia complex contamination.
>
> I also wonder whether Burkholderia multivorans and Burkholderia cenocepacia
> would actually be detected in a purified water sample by conducting
> enrichment.  In a purified water system, the microbial population is not a
> monoculture environment.  Several different species can be present within a
> purified water system at the same time due to the microbial variability of
> the source water.  In addition, water borne organisms that have a faster
> growth rate may inhibit the detection of Burkholderia cenocepacia and
> Burkholderia multivorans by using TSB enrichment of USP Chapter 60 due to
> their slower growth rates.
>
> In regards to my statements on this subject, I believe that some people
> will agree with me and others would like to burn me at the stake by
> providing the wood because I question the expertise of the USP Microbiology
> Committee.  However, I believe that the purpose of this forum is
> educational by having the free exchange of different viewpoints on a
> subject.  This is what makes Microbiology fun.  We all learn in the end.
>
> Regards,
> Don
>
> Donald J. English Microbiological Quality Consulting LLC
> Florham Park, New Jersey
>
>
>
> Don
>
>
>
>
>
> On Tue, Jul 21, 2020 at 6:30 PM Stephen Langille <[log in to unmask]>
> wrote:
>
> > Don and Alison,
> >
> > I can't speak for all regulatory authorities but the FDA almost never
> > requires speciation of WFI isolates due to the significant downstream
> > sterilization controls that are implemented to neutralize the bulk drug
> > product bioburden.  Speciation could be requested to investigate a
> > catastrophic sterility assurance failure but it's rare.  The choice not
> to
> > speciate WFI organisms is supported by a risk assessment showing that the
> > levels of microbial contamination in the raw materials (including water)
> > and pre-filtration bioburden cannot withstand the sterilization process
> and
> > are not of a sufficient population to affect the purity, strength,
> potency
> > or quality of the finished drug product.  The same risk assessment
> process
> > can be used to determine if testing for B. cepacia complex in
> > pharmaceutical water systems used for the manufacture of non-sterile drug
> > products is necessary.  Usually it is not, but there are instances where
> > testing water systems for B. cepacia complex may be b!
> >  eneficial due to factors such as manufacturing/product history, weak
> > downstream controls, or the unique nature/intended patient population of
> > the drug product.
> >
> > Best,
> >
> > Steve
> >
> > -----Original Message-----
> > From: The Pharmaceutical Microbiology Forum Email List <
> > [log in to unmask]> On Behalf Of Donald English
> > Sent: Sunday, July 19, 2020 8:06 PM
> > To: [log in to unmask]
> > Subject: Re: [PMFLIST] Chapter <60>
> >
> > Hi Allison,
> >
> > I see that no one had responded back to your posting about using USP
> > Chapter 60 in a sterile manufacturing facility.
> >
> > In the introduction of USP Chapter 60, it is stated as follows:
> >
> > The tests are designed to determine whether a substance or preparation
> > complies with an established specification for microbiological quality
> > and/or to evaluate whether products—especially those for inhalation use
> or
> > aqueous preparations for oral, oromucosal, cutaneous, or nasal
> use—contain
> > members of the Bcc.
> >
> > In reality, there is no reason for using USP Chapter 60 because the
> > chapter is for non-sterile aqueous and inhalation products based upon the
> > introduction of the chapter.  However, it is stated in the testing
> product
> > section that it may be used for the testing of pharmaceutical waters.  It
> > would be interesting to see if regulatory authorities would require
> > Water-for-Injection that is used for making sterile product formulations
> be
> > tested for the presence of Burkholderia cepacia complex by using the
> > methodology of this chapter by having this particular sentence in the
> > chapter.
> >
> > By having this sentence present in the chapter, I would suspect that you
> > would be required to conduct Burkholderia cepacia complex of collected
> > Water-for-Injection samples because it is kind of vague of what is meant
> as
> > pharmaceutical water in the chapter.  From my perspective, the presence
> of
> > any Gram-negative bacterial species in Water-for-Injection samples would
> be
> > objectionable.
> >
> > Regards,
> > Don
> >
> > Donald J. English Microbiological Quality Consulting LLC Florham Park,
> New
> > Jersey 07932
> >
> >
> >
> >
> >
> >
> >
> > On Fri, Jul 17, 2020 at 7:35 AM Berman, Alison <
> [log in to unmask]
> > >
> > wrote:
> >
> > > Hello,
> > >
> > > Is anyone performing chapter <60> testing at a sterile injectable
> > > manufacturing company, at any stage of manufacturing?
> > > Is there any reason one may do so and if yes, on what would the test
> > > be performed?
> > >
> > >
> > > Thanks
> > >
> > >
> > >
> > > Alison Berman, MFS
> > > Supervisor
> > > Quality Control - Microbiology
> > >
> > > [AMR_Logo_for Email Signatures_19DEC]
> > >
> > > O 631.924.4000 ext. 379
> > > [log in to unmask]<mailto:[log in to unmask]>  \\
> > > americanregent.com
> > >
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> > > =================================
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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/
> >
> >
> > =================================
> > The nature of this service is to provide a medium for communication.  The
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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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>
> ------------------
> The PMFList is supported by our sponsors as a service to the scientific
> community.
>
> Please take a second to visit our sponsors' web sites and say thank you
> for their support of this service.
> If your company would be interested in sponsoring this community, please
> contact [log in to unmask]
>
>
>
> 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/
>
>
> =================================
> The nature of this service is to provide a medium for communication.  The
> specific statements and endorsements of individuals participating in the
> discussions are not necessarily those of the PMF or the sponsors of the
> list.
>

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The PMFList is supported by our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



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/


=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of the PMF or the sponsors of the list.

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