PMFLIST Archives

July 2020

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 21 Jul 2020 12:21:14 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (515 lines)
Forum Members,

The purpose of official USP test methods is to provide a test, if a
requirement for the absence of Bcc is added to a USP product monograph. As
stated in the chapter, the test is directed towards aqueous, non-sterile
dosage forms.

Given the ingredients, manufacturing process, and product microbiological
and physicochemical attributes of a compressed tablet or powder-filled
capsule, in my expert opinion, I would not recommend screening solid, oral
dosage forms for the absence of Bcc.

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.

Tony

On Tue, Jul 21, 2020 at 11:36 AM Timothy Cser <
[log in to unmask]> wrote:

> Hi Tony.  I think the operative words are "pharmaceutical" and
> "Optional".  With USP chapters under 1000 I think this type of wording can
> cause confusion.  I specifically asked the FDA about this topic at PDA
> Micro in 2019 and I was told it's a firm "no" on USP being intended for
> parenteral manufacturers as it's intended as a non-sterile product test.  I
> know the intent was to give an additional method for testing water because
> that's where Bcc often resides and if firms want to test their water, this
> is one validated method.  That being said, using the term "pharmaceutical
> waters" is very broad and is probably causing the most confusion in this
> chapter.  After speaking with you (indirectly) and the FDA at the PDA, I
> walked away with the impression that USP 60 is only intended for
> non-sterile, aqueous product manufacturers.  That being said, through this
> forum, we've discovered other non-sterile "non-aqueous" manufacturers who
> make dry powders for inhalation, who also test f!
>  or Bcc because their patient population is at risk.  I believe it is a
> full expectation that every non-sterile, aqueous manufacturer should be
> testing for Bcc but that other firms will also perform the testing because
> their patient population is at risk, even though the product is non-aqueous.
>
> If a firm is producing a non-sterile, aqueous product and are performing
> USP 60 on the final product, that will fulfill the testing requirements and
> if Bcc has been found in the water system in the past, I would think
> testing the water system more frequently to prevent product contamination
> would be a good idea.....that's just my 2c 😊
>
> Sincerely,
>
> Tim Cser
> MilliporeSigma
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]> On Behalf Of Tony Cundell
> Sent: Monday, July 20, 2020 11:05 AM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Chapter <60>
>
> Don,
>
> The chapter does not make that recommendation.
>
> It states in the introduction the following:
>
> 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.
> It does caution that if you apply the method as an optional test for
> pharmaceutical grade water that you use a 1:10 dilution. There is no
> recommendation that purified water be routinely tested using USP <60>.
>
> Tony
>
> On Mon, Jul 20, 2020 at 1:23 PM Donald English <
> [log in to unmask]>
> wrote:
>
> > Dear Tony,
> >
> > I do agree that WFI is not used in the manufacturing of non-sterile
> > products.  However, it is stated in the chapter that it is recommended
> > pharmaceutical waters should be tested for Burkholderia cepacia
> > complex.
> >
> > Some people may think that they have to test WFI because it is a
> > pharmaceutical water.  The presence of the term “pharmaceutical water”
> > is misleading in the chapter and people may think otherwise.  It would
> > have been better if the chapter had stated that water that is used in
> > the manufacturing of non—sterile should be tested for the presence of
> > Burkholderia cepacia complex to prevent people in applying this
> > chapter to WFI.
> >
> > Don
> >
> > Donald J. English Microbiological Quality Consulting LLC Florham Park,
> > New Jersey 07932 Sent from my iPhone
> >
> > > On Jul 20, 2020, at 10:13 AM, Tony Cundell <[log in to unmask]>
> > wrote:
> > >
> > > ï»żDon as WFI is not used for the manufacturing of non-sterile
> > > products
> > there
> > > would be no reason to test it for Bcc.
> > >
> > >> On Sun, Jul 19, 2020, 10:16 PM Donald English <
> > [log in to unmask]>
> > >> wrote:
> > >>
> > >> 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
> > >>>
> > >>> CONFIDENTIALITY NOTE: This e-mail and any attachments are
> > >>> confidential
> > >> and
> > >>> may be protected by legal privilege. If you are not the intended
> > >> recipient,
> > >>> be aware that any disclosure, copying, distribution or use of this
> > e-mail
> > >>> or any attachment is prohibited. If you have received this e-mail
> > >>> in
> > >> error,
> > >>> please notify us immediately by returning it to the sender and
> > >>> delete
> > >> this
> > >>> copy from your system. Thank you for your cooperation.
> > >>>
> > >>> ------------------
> > >>> 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 -
> > >>> https://clicktime.symantec.com/3EC7tj6kfQLoRgbB5S21KFR6H2?u=http%3
> > >>> A%2F%2Fwww.sterislifesciences.com%2F
> > >>>
> > >>> Charles River Laboratories -
> > >>> https://clicktime.symantec.com/3PYxw6Lf6U8pZGLA8QmcZXe6H2?u=https%
> > >>> 3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6
> > >>>
> > >>> Veltek Associates, Inc -
> > >>> https://clicktime.symantec.com/3Jy7K2gmkoFEdiVi5sARYgF6H2?u=http%3
> > >>> A%2F%2Fwww.sterile.com
> > >>>
> > >>> Microbiologics, Inc. -
> > >>> https://clicktime.symantec.com/3MeTLBykjY8LvYe8E4qt1BG6H2?u=http%3
> > >>> A%2F%2Fwww.microbiologics.com
> > >>>
> > >>> BD Industrial Media -
> > >>> https://clicktime.symantec.com/353EY9aq7nbHzDHjCeZrCyz6H2?u=http%3
> > >>> A%2F%2Fwww.bd.com%2Fds%2F
> > >>>
> > >>> Associates of Cape Cod, Inc. -
> > >>> https://clicktime.symantec.com/33gxjUiGxBL4ZS4SjeXQ17r6H2?u=http%3
> > >>> A%2F%2Fwww.acciusa.com%2F
> > >>>
> > >>>
> > >>> =================================
> > >>> 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.
> > >>>
> > >>
> > >> ------------------
> > >> 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 -
> > >> https://clicktime.symantec.com/3EC7tj6kfQLoRgbB5S21KFR6H2?u=http%3A
> > >> %2F%2Fwww.sterislifesciences.com%2F
> > >>
> > >> Charles River Laboratories -
> > >> https://clicktime.symantec.com/3PYxw6Lf6U8pZGLA8QmcZXe6H2?u=https%3
> > >> A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6
> > >>
> > >> Veltek Associates, Inc -
> > >> https://clicktime.symantec.com/3Jy7K2gmkoFEdiVi5sARYgF6H2?u=http%3A
> > >> %2F%2Fwww.sterile.com
> > >>
> > >> Microbiologics, Inc. -
> > >> https://clicktime.symantec.com/3MeTLBykjY8LvYe8E4qt1BG6H2?u=http%3A
> > >> %2F%2Fwww.microbiologics.com
> > >>
> > >> BD Industrial Media -
> > >> https://clicktime.symantec.com/353EY9aq7nbHzDHjCeZrCyz6H2?u=http%3A
> > >> %2F%2Fwww.bd.com%2Fds%2F
> > >>
> > >> Associates of Cape Cod, Inc. -
> > >> https://clicktime.symantec.com/33gxjUiGxBL4ZS4SjeXQ17r6H2?u=http%3A
> > >> %2F%2Fwww.acciusa.com%2F
> > >>
> > >>
> > >> =================================
> > >> 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.
> > >>
> > >
> > > ------------------
> > > 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 -
> > > https://clicktime.symantec.com/3EC7tj6kfQLoRgbB5S21KFR6H2?u=http%3A%
> > > 2F%2Fwww.sterislifesciences.com%2F
> > >
> > > Charles River Laboratories -
> > https://clicktime.symantec.com/3PYxw6Lf6U8pZGLA8QmcZXe6H2?u=https%3A%2
> > F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6
> > >
> > > Veltek Associates, Inc -
> > > https://clicktime.symantec.com/3Jy7K2gmkoFEdiVi5sARYgF6H2?u=http%3A%
> > > 2F%2Fwww.sterile.com
> > >
> > > Microbiologics, Inc. -
> > > https://clicktime.symantec.com/3MeTLBykjY8LvYe8E4qt1BG6H2?u=http%3A%
> > > 2F%2Fwww.microbiologics.com
> > >
> > > BD Industrial Media -
> > > https://clicktime.symantec.com/353EY9aq7nbHzDHjCeZrCyz6H2?u=http%3A%
> > > 2F%2Fwww.bd.com%2Fds%2F
> > >
> > > Associates of Cape Cod, Inc. -
> > > https://clicktime.symantec.com/33gxjUiGxBL4ZS4SjeXQ17r6H2?u=http%3A%
> > > 2F%2Fwww.acciusa.com%2F
> > >
> > >
> > > =================================
> > > 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.
> >
> > ------------------
> > 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 -
> > https://clicktime.symantec.com/3EC7tj6kfQLoRgbB5S21KFR6H2?u=http%3A%2F
> > %2Fwww.sterislifesciences.com%2F
> >
> > Charles River Laboratories -
> > https://clicktime.symantec.com/3PYxw6Lf6U8pZGLA8QmcZXe6H2?u=https%3A%2
> > F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6
> >
> > Veltek Associates, Inc -
> > https://clicktime.symantec.com/3Jy7K2gmkoFEdiVi5sARYgF6H2?u=http%3A%2F
> > %2Fwww.sterile.com
> >
> > Microbiologics, Inc. -
> > https://clicktime.symantec.com/3MeTLBykjY8LvYe8E4qt1BG6H2?u=http%3A%2F
> > %2Fwww.microbiologics.com
> >
> > BD Industrial Media -
> > https://clicktime.symantec.com/353EY9aq7nbHzDHjCeZrCyz6H2?u=http%3A%2F
> > %2Fwww.bd.com%2Fds%2F
> >
> > Associates of Cape Cod, Inc. -
> > https://clicktime.symantec.com/33gxjUiGxBL4ZS4SjeXQ17r6H2?u=http%3A%2F
> > %2Fwww.acciusa.com%2F
> >
> >
> > =================================
> > 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.
> >
>
>
> --
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [log in to unmask]
> Phone: 914 725-3947
> Cell: 914 841-0074
>
> ------------------
> 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 -
> https://clicktime.symantec.com/3EC7tj6kfQLoRgbB5S21KFR6H2?u=http%3A%2F%2Fwww.sterislifesciences.com%2F
>
> Charles River Laboratories -
> https://clicktime.symantec.com/3PYxw6Lf6U8pZGLA8QmcZXe6H2?u=https%3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6
>
> Veltek Associates, Inc -
> https://clicktime.symantec.com/3Jy7K2gmkoFEdiVi5sARYgF6H2?u=http%3A%2F%2Fwww.sterile.com
>
> Microbiologics, Inc. -
> https://clicktime.symantec.com/3MeTLBykjY8LvYe8E4qt1BG6H2?u=http%3A%2F%2Fwww.microbiologics.com
>
> BD Industrial Media -
> https://clicktime.symantec.com/353EY9aq7nbHzDHjCeZrCyz6H2?u=http%3A%2F%2Fwww.bd.com%2Fds%2F
>
> Associates of Cape Cod, Inc. -
> https://clicktime.symantec.com/33gxjUiGxBL4ZS4SjeXQ17r6H2?u=http%3A%2F%2Fwww.acciusa.com%2F
>
>
> =================================
> 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.
>
>
> This message and any attachment are confidential and may be privileged or
> otherwise protected from disclosure. If you are not the intended recipient,
> you must not copy this message or attachment or disclose the contents to
> any other person. If you have received this transmission in error, please
> notify the sender immediately and delete the message and any attachment
> from your system. Merck KGaA, Darmstadt, Germany and any of its
> subsidiaries do not accept liability for any omissions or errors in this
> message which may arise as a result of E-Mail-transmission or for damages
> resulting from any unauthorized changes of the content of this message and
> any attachment thereto. Merck KGaA, Darmstadt, Germany and any of its
> subsidiaries do not guarantee that this message is free of viruses and does
> not accept liability for any damages caused by any virus transmitted
> therewith.
>
>
>
> Click http://www.merckgroup.com/disclaimer to access the German, French,
> Spanish and Portuguese versions of this disclaimer.
>
> ------------------
> 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.
>


-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

------------------
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.

ATOM RSS1 RSS2