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February 2020

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Subject:
From:
Marc Glogovsky <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 6 Feb 2020 12:37:17 -0500
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Ramesh,

There is no guidance for which flow rate to utilize.

However, you must ensure that the sampler does not create turbulence not generate particles and can be properly disinfected.  Placement of the units is therefore critical (I do not condone the use of a portable sampler in an ISO 5 environment).

At 200 L/min (5 minutes time) that as an awfully small snapshot of time to detect contamination or deterioration of the environment.  Be prepared to take more samples.

You’re free to use whatever sampler you want, however, be sure justify and rationalize it’s use in your EM program.  The manufacturer should provide you the physical and biological efficiency of the sampler (ISO 14698 validation) to support your justification.

Marc Glogovsky, MS, S.M. (NRCM)
Senior Consultant - Microbiology

918A Horseshoe Pike, Downingtown, PA 19335
P: 610.269.2808 | F: 610.269.4069
M: 609.432.1314 | valsource.com

> On Feb 6, 2020, at 6:32 AM, Ramesh <[log in to unmask]> wrote:
> 
> Hello all,
> 
> I would like to know is there any guidelines mentioned airsamplers airflow
> rates?
> 
> Most of them are following 100 lit/min and 180 lit/min air flow rates which
> guidelines is saying to follow these air sampling
> 
> If I follow 200 lit/ min air sampling (5 mins) to save the time and work
> load
> Is it acceptable 200 lit/min air sampling in pharmaceutical clean rooms ?
> 
> Please share any document references for airflow rate for airsamplers.
> 
> Thanking you in advance
> 
> Best Regards,
> Ramesh
> 
> 
> 
> 
> 
> air flow rate of 100 litres/min
> 
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The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and 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.
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Steris - http://www.sterislifesciences.com/

Charles River Laboratories - http://www.criver.com/

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

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

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