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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 5 Sep 2019 17:37:17 +0200
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Dear Manohar,

You can find some prosa to this topic here: 
https://www.testotis.de/fileadmin/testotis.de/downloads/fachartikel/Uebersicht_regulatorischer_und_normativer_Anforderungen_fuer_die_Reinraumqualifizierung.pdf
Sorry, that it is only in German.

Those are my sentiments:
For iso class 8 the max. period should be 3 months to 1 year,
for iso class 7 the max. period should be 1 month to 6 months,
but have no guideline available at the moment.

If you produce vaccines, please refer to: 
https://www.who.int/immunization_standards/vaccine_quality/env_monitoring_cleanrooms_final.pdf

With kind regards

i.A. Mario Schüngel
Manager Environmental Monitoring
Quality Unit
Quality Assurance - Standards & Compliance
Tel. +49.2524.268.520
Fax +49.2524.268.4520
Mobil: +49.2524.268.704 



Von:    Manoher Kollu <[log in to unmask]>
An:     [log in to unmask]
Datum:  05.09.2019 15:57
Betreff:        [PMFLIST] frequency of environmental monitoring
Gesendet von:   The Pharmaceutical Microbiology Forum Email List 
<[log in to unmask]>



Dear forum members,

What is the frequency of microbial (environmental) monitoring in clean 
rooms (for iso class 8 and class 7)
What is the frequency of settle plate and what is the frequency of air 
sampler.
Please send me any reference guide lines


Thanks & Best Regards,
Manohar. K
Cell:9700061191
        8555005265


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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.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Science Advisory Board https://www.scienceboard.net/

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/


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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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