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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sun, 19 Jul 2020 20:06:24 -0400
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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
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> Veltek Associates, Inc - http://www.sterile.com
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> Microbiologics, Inc. - http://www.microbiologics.com
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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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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 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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