Michael,

Got you beat by 6 years.

Anderson A.S. Bassett G. Burke M.T. Cotton M.L. *Cundell* A.M. Dammers F.
Deschenes R. Home Flood M. Greene M. Karaim M. May J. Mestrandrea L.W.
Metzger Miller K.S. Munson J.W. Orlowski S.J. Price J.M. Schady K. Shirtz
J. Vanjonack W.J. Williams R. R. Winely C. Wilson J.D. White T.
Microbiological monitoring of  environmental conditions for non-sterile
pharmaceutical manufacturing. *Pharmaceutical Technology.  21(3) (pp
58-74+10), 1997*

*Tony*

On Wed, May 10, 2023 at 3:50 PM Dr. Michael J. Miller <
[log in to unmask]> wrote:

> Twenty (20) years ago, I published a paper on establishing EM levels for
> nonsterile manufacturing. I cannot find the reprint but maybe you can do a
> search:
>
>
>
> 2003. Reich, R.; Miller, M.; Patterson, H. Developing a viable
> environmental monitoring program for nonsterile pharmaceutical operations.
> Pharmaceutical Technology. March 2003.
>
>
>
>
>
>
>
> From: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]> on behalf of Marc Glogovsky <
> [log in to unmask]>
> Reply-To: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]>
> Date: Wednesday, May 10, 2023 at 12:45 PM
> To: <[log in to unmask]>
> Subject: Re: [PMFLIST] specification of settled plate of non sterile solid
> dosage manufacturing
>
>
>
> In a non-sterile facility you would use a risk-based approach (including
> historical/trend EM data) to establish an appropriate alert & action
> level.  You would use these metrics to ensure that you are in a state of
> control.
>
>
>
> I would point you towards USP <1115> as well as the current FDA draft
> guidance on Microbiological Quality Considerations for non-sterile drug
> manufacturing (https://www.fda.gov/media/152527/download).
>
>
>
> Of course, take a look at as many of the reference articles in both
> aforementioned documents as they all offer great supporting information.
>
>
>
> Sincerely,
>
>
>
> Marc Glogovsky, MS, S.M. (NRCM)
>
> Business Unit Manager - Microbiology Consulting
>
> 609.432.1314
>
>
>
> valsource.com<https://www.valsource.com/>
>
>
>
> From: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]> on behalf of Lim Foong Choo <
> [log in to unmask]>
>
> Date: Wednesday, May 10, 2023 at 9:03 AM
>
> To: [log in to unmask] <
> [log in to unmask]>
>
> Subject: [PMFLIST] specification of settled plate of non sterile solid
> dosage manufacturing
>
> Dear PMF members,
>
>
>
>
>
>
>
> What is the specification of settled plate (cfu/plate/4 hours)
> specification
>
> of non-sterile manufacturing facility ?
>
>
>
> Shall I know the references ?
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
> Regards,
>
>
>
>
>
>
>
> Lim
>
>
>
>
>
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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Veltek Associates, Inc - http://www.sterile.com

Special Process Services, LC - https://www.linkedin.com/in/joseph-connaghan-b663929



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