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September 2012

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Subject:
From:
Maria Bermejo González <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 4 Sep 2012 15:02:55 +0200
Content-Type:
text/plain
Parts/Attachments:
text/plain (93 lines)
In the annex I Manufacture of Sterile Medicinal Products, the recommended limit during operation is 50 cfu/4hours in Grade C.

..........................................
María Bermejo González
Técnico Control de Calidad
Unidad de Apoyo de Producción Celular
Centro Andaluz de Biología Molecular y Medicina Regenerativa
Edif. CABIMER - Avda. Américo Vespucio s/n.
Parque Científico y Tecnológico Cartuja 93. 41092 Sevilla
Tlf:   +34 954 467967    Fax: +34 954 461 664
www.cabimer.es

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-----Mensaje original-----
De: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] En nombre de Cintia Berdat
Enviado el: lunes, 03 de septiembre de 2012 16:35
Para: [log in to unmask]
Asunto: [PMFLIST] Limit for viable particles

Can anyone tell me the limit for viable particles (CFU/4 h) in ISO7 and ISO8 "at rest" and "in operation"? Thanks in advance!


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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

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

Biolog - http://www.biolog.com

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

EMD Millipore -  http://bit.ly/Udi4CP

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

=================================
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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