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,
> biomarkers. We are not pharmaceutical, and as such are not
> as tightly
> We have controlled areas that are composed of 3 ISO class 6
> 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
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