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:
Mon, 20 Jul 2020 14:04:42 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (305 lines)
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:
> >
> > Don 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 - 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.
> >>>
> >>
> >> ------------------
> >> 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.
> >>
> >
> > ------------------
> > 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.
>
> ------------------
> 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