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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 1 Jun 2023 14:36:31 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (187 lines)
Dear all,

I have been following this exchange.  Regarding limits, it is true
that most companies are setting their own in-house limits for
non-sterile product manufacturing areas and are using Soybean-Casein
Digest Agar Medium (TSA) as the microbial growth medium to detect the
presence of airborne organisms.

However, I do find that some companies are not classifying their
non-sterile product manufacturing areas by using particulate counts
but are controlling the microbial content of the air by using HEPA
filters in the HVAC system.  They are mostly using the microbial count
limits of a Grade D area of ISO 14644 since they are not doing
classification studies by performing particulate count studies.  In
reviewing the microbial test data from air sampling, they are within
the microbial counts for a Grade D area.  They are calling these areas
Controlled but Not Classified (CNC).  In the WHO documents, I see that
they are recommending the use of an ISO Class 8 or Grade D area for
processing areas.  I find in general that the filling areas have
equipment in which the filling of product containers is occurring
somewhat in a so-called closed area of the filling equipment in which
the filling heads of the filling equipment are enclosed behind
plexiglass walls.  I believe that the plexiglass enclosures of the
filling heads are more for safety of personnel than for controlling
the introduction of air microbial contaminants during the filling
process.  In WHO TRS, No. 961, Annex 8 – 2018 – Guidelines on Heating,
Ventilation and Air Conditioning Systems for Non-sterile
Pharmaceutical Products, they are stating that HEPA filters may not be
required to control cross-contamination where there is evidence that
cross-contamination would not be possible has been obtained by other
robust technical means.  Without the presence of an HEPA filter in an
HVAC system for a non-sterile manufacturing area to control particles,
I do not believe that an ISO air room classification can be obtained.

In general, there seems to be a lack of requirements for air
classification of non-sterile manufacturing areas in regulatory
guidance documents.  I do not expect one any time soon.  When it comes
to controlling microbial contamination in non-sterile product
formulations, the bigger issues seem to be in purified water systems
and errors occurring during cleaning and sanitization of manufacturing
equipment than the microbial content than the air of the facility.

Don

Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932

On Wed, May 31, 2023 at 5:10 PM Tony Cundell <[log in to unmask]> wrote:
>
> As soybean-Casein Digest agar is the primary medium used in EM. The growth
> promotion testing will confirm that each batch of media can isolate
> bacteria, yeast and mold.
>
> The results are reported as a total aerobic microbial count. The repeat
> isolation of any species of microorganism is part of trending the data so
> repeated fungal isolation would be acted upon as mold growing in our
> facility or being brought in on equipment, material or personnel.
>
> On Wed, May 31, 2023 at 10:04 AM Rabia Begum (Sr. Manager Microbiology) <
> [log in to unmask]> wrote:
>
> > Dear Forum Member,
> > What is industry’s best practice for fungal count and its limits during
> > Environmental monitoring of non-sterile product manufacturing.
> >
> > Regards,
> >
> > Rabia Begum
> > Senior Manager Microbiology
> > Quality Control Department
> > Getz Pharma Pakistan
> >
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> --
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [log in to unmask]
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> Current Sponsors:
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> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> Novatek International https://ntint.com/
>
> Steris - http://www.sterislifesciences.com/
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Special Process Services, LC - https://www.linkedin.com/in/joseph-connaghan-b663929
>
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>
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> 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 PMF or the sponsors of the list.

------------------
The PMFList is supported by our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites.  Let them know you saw them on our list and appreciate their support of this service.

If your company would be interested in sponsoring this community, please contact [log in to unmask] or by completing the sponsorship form here: https://bit.ly/3FsEVrW



Current Sponsors:

Associates of Cape Cod, Inc. - http://www.acciusa.com/

Microbiologics, Inc. - http://www.microbiologics.com

Novatek International https://ntint.com/

Steris - http://www.sterislifesciences.com/

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

Special Process Services, LC - https://www.linkedin.com/in/joseph-connaghan-b663929



=================================
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 PMF or the sponsors of the list.

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