For risk mitigation with media contacting process equipment like tanks and
filling lines the first response was to substitute plant-based
microbiological media however this material may eliminate animal virus but
could contain mycoplasma that may grow and create turbid and has lower
growth promotion.
 capabilities.

So some suppliers promoted animal based irradiated dehydrated media.



On Wed, Feb 8, 2023 at 11:19 PM JUAN JOSE VERAMENDI ORTIZ <
[log in to unmask]> wrote:

> hi Tim...
>
> As I told you, the auditor questioned the use of this irradiated medium,
> which was strange and perhaps absurd, simply for us it is eliminating a
> variable
>
> The reformulated question would be how much the irradiated medium is being
> used worldwide, given that in Latin America it is very little used for
> simulated aseptic fillings, and it is not wrong to use the others clearly,
> it is simply to have feedback about the use of the irradiated medium.
>
> regards
>
> Juan Jose
>
> El mié, 8 feb 2023 a la(s) 17:04, Timothy Cser (
> [log in to unmask]) escribió:
>
> > HI Juan.  I'm a little confused by your question but if you're getting a
> > question about whether or not non-animal irradiated media is appropriate,
> > this is the first I've heard of it.
> >
> > The FDA Aseptic Guide states " In general, a microbiological growth
> > medium, such as soybean casein digest medium, should be used. Use of
> > anaerobic growth media (e.g., fluid thioglycollate medium) should be
> > considered in special circumstances. The media selected should be
> > demonstrated to promote growth of gram-positive and gram-negative
> bacteria,
> > and yeast and mold (e.g., USP indicator organisms)."
> >
> > Irradiation is not mentioned and yes, you're correct, the medium is
> > irradiated to eliminate mycoplasma and organisms that could cause false
> > positives.  We growth promote (and so do you) every lot of irradiated
> media
> > and we have over 15 years of experience using this media.  Finally, we've
> > performed full irradiation studies to find the correct irradiation dose
> to
> > sterilize the media, yet keep it fertile.
> >
> > In 17 years, I've never heard of an auditor questioning the use of
> > irradiated media in media fills.
> >
> > Sincerely,
> > Tim Cser
> > Senior Technology Specialist
> > MilliporeSigma
> >
> > -----Original Message-----
> > From: The Pharmaceutical Microbiology Forum Email List <
> > [log in to unmask]> On Behalf Of JUAN JOSE VERAMENDI
> > ORTIZ
> > Sent: Wednesday, February 8, 2023 11:47 AM
> > To: [log in to unmask]
> > Subject: [PMFLIST] irradiated culture media
> >
> > [WARNING - EXTERNAL EMAIL] Do not open links or attachments unless you
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> >
> >
> > hello to all colleagues
> >
> > I would like your feedback on the use of irradiated culture media used in
> > the simulation of aseptic fills.
> >
> > Recently an auditor told us that the use of an irradiated medium does not
> > represent the reality of the contamination, our response was that the
> > formulations we have do not promote bacterial growth as a culture medium
> > can, and for us we simply use the irradiated ones. It is to have a
> > controlled external contamination variable.
> >
> > In the same way I made the reference to the FDA questions and answers
> > current good manufacturing practice regulations-production and process,
> > where he gives a good example in point 3.
> >
> > To all this I accept the answer, check with MERCK for your sales in Latin
> > America and really very few use irradiated media.
> >
> > greetings I hope your feedback.
> >
> > JUAN JOSÉ
> >
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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Novatek International https://ntint.com/

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Veltek Associates, Inc - http://www.sterile.com



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