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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:
Mon, 13 Jul 2020 11:32:39 -0400
Content-Type:
text/plain
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Typically non-sterile product manufacturing areas are not designed for or
classified as to air cleanliness standards. If you use active air sampling
what acceptance criterion will you use?

For a balanced discussion on the issue I would refer you to USP <1115>
Bioburden Control of Non-sterile Drug Substances and Products.

Tony

On Mon, Jul 13, 2020 at 11:21 AM Joseph Crnkovich <[log in to unmask]>
wrote:

> Settle plates are generally frowned upon as inaccurate but it falls in the
> "something is better than nothing" category since not everyone has access
> to an air sampler.
>
> On Mon, Jul 13, 2020, 6:18 AM Akhilesh Chaturvedi <
> [log in to unmask]> wrote:
>
> > I have a question regarding facility EM qualification. During EM
> > qualification, should we use Volumetric air sampling OR settling plate
> > method for Non-Sterile facility.  What is your opinion?
> >
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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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> > =================================
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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.
>


-- 
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.

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