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June 2020

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Subject:
From:
Selena Rossi <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 26 Jun 2020 09:50:23 +0200
Content-Type:
text/plain
Parts/Attachments:
text/plain (140 lines)
Hi Tony,
could you tell me where is indicated the air monitoring for non sterile
manufacturing in EU Annex 13.
I'm referring to USP 1115, but I work in Italy, so a EU guidance is
preferred for us.

Thanks,
Selena

Il giorno ven 19 giu 2020 alle ore 09:19 Tony Cundell <[log in to unmask]>
ha scritto:

> Other than the EU Annex 13 requirement for conducting inhalant
> manufacturing in a Class D environment there is no air
> cleanliness standards mandated for non-sterile drug manufacturing. The
> frequency of monitoring should reflect the risk associated with the dosage
> form and may be weekly, monthly or quarterly.
>
> I recommend you refer to USP <1115> Bioburden Control of Non-sterile Drug
> Substances and Products.
>
> On Thu, Jun 18, 2020 at 11:12 AM Ankit Johri <[log in to unmask]>
> wrote:
>
> > Respected forum members,
> >
> >  Can anyone tell what is frequency of settle plate and active air
> sampling
> > in Class D area for non sterile manufacturing units .
> >
> >
> >
> > Regards
> >
> > ankit
> >
> >
> >
> > Information transmitted by this E-MAIL is proprietary to T. C. Health
> Care
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> intended
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> >
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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/
> >
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> > =================================
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>
> --
> 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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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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