PMFLIST Archives

March 2012


Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
chiliveri goud <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Tue, 6 Mar 2012 20:10:38 +0800
text/plain (91 lines)
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?
> ############################
> To unsubscribe from the PMFLIST list:
> write to: mailto:[log in to unmask]
> or click the following link:

The PMFList ( is operated from
The Microbiology Network ( 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.

Accugenix -

American Type Culture Collection -

BD Diagnostic Systems -

Biolog -

Biomerieux -

Biotest -

Lonza Rapid Testing Solutions -

MicroBioLogics, Inc. -

Pall -

NovaTek International -

Rapid Micro Biosystems -  (formerly GPS)

Steris -

Veltek Associates, Inc -

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.