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June 2020

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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:
Thu, 18 Jun 2020 11:44:06 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (93 lines)
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
> Pvt. Ltd. and/ or its Group Companies and/or, its Customers and is intended
> for use only by the individual or entity to which it is addressed.
>
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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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-- 
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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