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November 2013

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Subject:
From:
"Polarine, Jim" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 14 Nov 2013 15:10:47 -0600
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text/plain
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Sara:

I generally recommend using a surfactant based disinfectant on a routine basis in a Grade A and Grade B Cleanroom.  If the Grade B cleanroom is an ISO-5 room then the products used in it should be rendered sterile prior to use.  I would also recommend using a sporicide such as a hydrogen peroxide/peracetic acid blend on a routine basis based upon the frequency of fungal and bacterial spores. The use of the liquid hydrogen peroxide/peracetic acid blend would be preferred, as it would typically include the mechanical removal aspect of wiping or mopping.

If VHP is validated (against EM spore formers on their surfaces), then it would also meet the expectation, however a pre-cleaning to remove organic residue prior to the VHP cycle may be needed. 

Feel free to contact me offline if I can be of further assistance.

Jim Polarine Jr.
 
Jim Polarine Jr., MA.
Formulated Chemistries
Technical Service Manager
STERIS Corporation
7405 Page Avenue
St. Louis, MO 63133-1032
Phone: 314-290-4793
Cell: 314-616-9931
Fax: 314-290-4612
E-mail: [log in to unmask]

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-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Sara Sevillano
Sent: Friday, November 08, 2013 5:24 AM
To: [log in to unmask]
Subject: [PMFLIST] sanitization program for grade B

Dear forum members,
can the following approach be considered  for the sanitization program for class B areas in aseptic processing?
- daily use of sterile disinfectant solution for surfaces cleaning (together with sterile IPA in spray);
- use of VHP (hydrogen peroxide vapor) for sanitization at the beginning of each production campaign, when this means peroxidation every 5-7 days.

Can this be considered a rotation? Is it appropriate?
Thanks in advance,
-- 

/Sara Sevillano Marcos/

*Technical** Services*

*CRYSTAL PHARMA --** **GADEA **Grupo Farmacéutico**    **www.gadea.com 
<http://www.gadea.com/>*

Tel.: +34 983 54 80 72 | Fax: + 34 983 54 81 13   

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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.


Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Accugenix - http://www.accugenix.com

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

ATS Labs - http://www.ats-labs.com

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

Biolog - http://www.biolog.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

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

Microtest Laboratories, Inc. - http://www.microtestlabs.com

Pall - http://www.pall.com

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

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

Steris - http://www.sterislifesciences.com/

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