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July 2020

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 9 Jul 2020 10:14:12 -0400
Content-Type:
text/plain
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text/plain (94 lines)
Reuven,

Ironically it is more challenging to justify a change than justifying the
original procedure.

My first exposure to media fills was with large volume parenterals and we
incubated the media fill at controlled room temperature for 14 days in
product storage and inspection area as we had no walk-in incubators, The
incubation conditions were justified by industry practice and growth
promotion testing.

The regs suggest any temperature between 20- 35 degree C that is justified.
My opinion incubation at 28 degree C for 14 days may be optimal.

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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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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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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