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March 2012

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Subject:
From:
chiliveri goud <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 6 Mar 2012 20:10:38 +0800
Content-Type:
text/plain
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what is your intended use are they injectables ?

--- On Tue, 6/3/12, Marc Herbranson <[log in to unmask]> wrote:

> From: Marc Herbranson <[log in to unmask]>
> Subject: [PMFLIST] Modified Media Fill?
> To: [log in to unmask]
> Date: Tuesday, 6 March, 2012, 1:00 AM
> Hello everyone,
> 
> Our company is a manufacturer of *in vitro* diagnostics,
> and
> biomarkers. We are not pharmaceutical, and as such are not
> as tightly
> regulated.
> 
> We have controlled areas that are composed of 3 ISO class 6
> cleanrooms.
> Instead of media fills, we perform yearly process
> qualifications for the
> filling machines inside the cleanrooms using a
> microbiological media in
> place of product to ensure that our filling operations
> don’t add bioburden
> to filled product.  A subset of the vials are then
> examined for microbial
> growth using the pour plate method. Our requirements state
> that a certain
> percentage of plates must be below a specified limit.
> 
> I have 2 questions:
> 
> 1.       Has anyone ever heard of
> process qualification fills like this
> other than the media fill listed in guidance
> procedures?  Media fill specs
> seem to be tighter than required for our processes, and the
> protocol we're
> working off of seems to have been grandfathered in from
> years past.
> 
> 2.       What percentage of bottles
> (based on the fill size) should be
> submitted to QC for testing if our maximum run size is
> 6500?
> 
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