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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:
Wed, 15 Jul 2020 22:03:56 -0400
Content-Type:
text/plain
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text/plain (126 lines)
Dear all,

I will admit that I have been out manufacturing sterile product formulations for awhile.

I fully understand the question about incubating media fill vials at 2 temperatures.  Some things do not change in this aspect.

However, I have a question concerning this post about the test organisms used for growth promotion testing of media fills.   

Why would anyone use Cutibacterium acnes as a growth promotion test organism for a media fill? Generally, this organism is an anaerobic microorganism that is present on the skin.  I fully understand that it is possible to isolate this organism in sterility testing of a sterile product by using FTM, but it only grows in TSB that has been supplemented with defribinated sheep blood that is incubated under anaerobic conditions besides using Reinforced Clostridial Medium.  I believe that TSB is mostly used as the microbial growth medium for conducting media fills.  Is this still correct?  I assume that it is.  I can understand that it may be possible for Cutibacterium acnes to grow in sealed TSB glass ampules of a media fill. Not sure with sterile containers with a rubber stopper.

I have 2 questions for the group .  Are people using Cutibacterium acnes as a growth promotion test organism for TSB media fills?  Is it standard practice for positive media fill containers for microbial growth would be identified to the genus/species level?  I suspect that this practice has not changed over the years.   Has anyone ever isolated Cutibacterium acnes in a TSB media fill container?

Just curious.

Don

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

Sent from my iPhone

> On Jul 15, 2020, at 5:44 PM, Tony Cundell <[log in to unmask]> wrote:
> 
>    -
> 
>  The 2004 FDA Aseptic Processing Guidance states:
> 
>  Incubation temperature should be suitable for recovery of bioburden and
>  environmental isolates and should at no time be outside the range of 20-35
>  oC. Incubation temperature should be maintained within +2.5oC of the
>  target temperature.
>  -
> 
>  Incubation time should not be less than 14 days. If two temperatures are
>  used for the incubation of the media filled units, the units should be
>  incubated for at least 7 days at each temperature (starting with the lower
>  temperature).
> 
>  Tony
> 
> 
>>> On Thu, Jul 9, 2020 at 9:51 AM Reuven Baum <[log in to unmask]> wrote:
>> We previously incubated media fills at 20-25C for 14 days.
>> We intend to change to 20-25C for 7 days followed by 30-35C for 7 days.
>> What level of justification is needed for this change ?
>> Is a risk assessment enough ?
>> Do we need to do a study with microorganisms  ?
>> Reuven
>> QC Microbiologist
>> Isotopia
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>> https://www2.criver.com/l/60962/2020-03-27/h6jqv6
>> Veltek Associates, Inc - http://www.sterile.com
>> Microbiologics, Inc. - http://www.microbiologics.com
>> BD Industrial Media - http://www.bd.com/ds/
>> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>> =================================
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> 
> 
> -- 
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [log in to unmask]
> Phone: 914 725-3947
> Cell: 914 841-0074
> 
> ------------------
> The PMFList is 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.
> If your company would be interested in sponsoring this community, please contact [log in to unmask]
> 
> 
> 
> Steris - http://www.sterislifesciences.com/
> 
> Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6
> 
> Veltek Associates, Inc - http://www.sterile.com
> 
> Microbiologics, Inc. - http://www.microbiologics.com
> 
> BD Industrial Media - http://www.bd.com/ds/
> 
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
> 
> 
> =================================
> 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 and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



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

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

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

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

BD Industrial Media - http://www.bd.com/ds/

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


=================================
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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