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October 2009

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Subject:
From:
Frank Settineri <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 26 Oct 2009 13:07:08 -0700
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Diana,

Sometimes even chemists are correct (just kidding). 

Most companies have a series of filters: 0.45 um, 0.22 um and 0.22 um.  If they have a holding tank they use two additional 0.22 um filters after it, prior to filling.  

In either case (one or two tanks) the bioburden is pulled after the 0.45 um filter; this is the only way to achieve <10 CFU/100ml on a consistent basis.  The EU accepts this as a norm so it's the way to go.  I found it hard to justify when I first learned about it 12 years ago, but have since accepted it.  

I can talk off line if you wish.  

Sincerely, 

Frank Settineri 
Veracorp LLC 
Sparta, New Jersey 
908-499-5540 
www.veracorp.biz  
http://www.linkedin.com/in/veracorp

"Strengthening businesses,
  strengthening lives" 

--- On Mon, 10/26/09, Jung Diana <[log in to unmask]> wrote:

From: Jung Diana <[log in to unmask]>
Subject: [PMFLIST] Bioburden limit and determination
To: [log in to unmask]
Date: Monday, October 26, 2009, 7:13 AM

Dear all,

 

I got some questions regarding the bioburden limit and determination. 

 

1)    Can anybody tell me if there is recommendation or specific
guideline for a reasonable Bioburden limit in aseptic production? What I
found is 10 CFU / 100ml according EU recommendation, whereas FDA does
not specify this.

2)    Many companies / co-packers use two reactors, one for the
preparation and one for transportation. My boss, btw he is a chemist,
claims that between the loads from reactor one to two a pre-filtration
is performed (this for reasons as samples are sometimes not directly
processed). The bioburden is than determined after this first
filtration, before the filling.

Is this really an ongoing practice? How can someone than justify the
bioburden and work with limits, as I would assume that this first
filtration lowers extremely the CFU.

3)    We are a small company therefore we are planning to use only one
reactor. Plans are also to install two filters that are series connected
before filling. 

Where do I determine in this set-up the bioburden after the first
filtration? Would this be this allowed? I thought the bioburden should
be determined before any filtration or am I complete wrong with this?

Looking forward to hearing from you. Any help/ guidance would be great.

 

Many thanks,

 

Diana

 

 

 


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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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