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 08:21:47 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (173 lines)
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.

ATOM RSS1 RSS2