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October 2009

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Subject:
From:
Fábio Pacheco <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 26 Oct 2009 16:40:59 -0700
Content-Type:
text/plain
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Hello,
please refer to USP 32, chapter <1116> Microbiological Evaluation of clean rooms and other controlled environments. Read it thoroughly and I believe you will find the answers you need.
You should also take a look at ISO 14698-1, about biocontamination.

Best regards,
Fabio Pacheco
Senior Microbiologist - São Paulo, BR.
http://microbiologyonlineblog.blogspot.com




________________________________
De: Tejal Chevli <[log in to unmask]>
Para: [log in to unmask]
Enviadas: Seg, Outubro 26, 2009 4:36:30 PM
Assunto: [PMFLIST] Environmental Monitoring

Hello All,


We are looking for guidance on performing environmental monitoring for a
non-sterile pharmaceutical manufacturing facility. The facility is
involved with manufacturing of liquids, topical creams and nasal sprays.
We are specifically looking for help in the following area:
1.    What should be the alert and actions limits for viable aerobic
microbial count by Sieve impacting system (MAS -100), surface sampling
(Swabs and Contact plates)
2.    We would also like to know if there are any guidelines for
absence of gram negative rods from the environment.
3.    What is the requirement for identifying the colonies recovered?

Monitoring for the facility is currently being performed for the
following areas
1.    Manufacturing Room
2.    Wash up Room
3.    Weigh up Room
4.    Tank Storage Area
5.    Warehouse corridor
6.    Manufacturing corridor 
7.    Sampling station

The current frequency for monitoring of these areas is quarterly. And
all environment needs to be free of any gram negative rods.

Any literature reference to aid us with this would be highly
appreciated. I thank you all in advance for your help.

Thanks,

Tejal Chevli 
Microbiologist
Innopharm A CPL Company
T] 905.470.2028 ext 304
F] 905.470.9241
E] [log in to unmask]
W] www.cplltd.com
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------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

Applied Biosystems, MicroSeq Microbial ID System - http://www.microseq.com/

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

EMD Chemicals - http://www.emdchemicals.com

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

Millipore - http://www.millipore.com

MODA Technology Partners - http://www.modatp.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

Raven Biological Labs - http://www.ravenlabs.com

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