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May 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:
Fri, 22 May 2020 12:18:34 -0400
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text/plain
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Mike with a 200 uL volume I assume that the product is a single-use dosage
so why would it be formulated with a antimicrobial preservative system?

If you want to conduct the AET you can use a larger volume of the
formulation in a suitable sized container.

Tony

On Fri, May 22, 2020 at 11:57 AM Michael Barton <[log in to unmask]>
wrote:

> Hi All,
> if the product is ~200ul contained within an assembled device how do you
> perform the AET test?
> The device will need to be completely disassembled to get to the internal
> liquid (200ul) contained within a small vial in the center of the device.
>
> Im assuming that this volume is too small to perform tetsing on as the
> inoculum volume of each organism will completely dilute the formulation.
> What volume do you need to use and how do you justify that or do you just
> need to show that your inoculum is between 1.0x10^5 to 1.0x10^6  per ml of
> product solution?
>
> Do you need to have representative containers manufactured to be the same
> material as what is in contact with the solution within the device?
> What about any closure/stopper in the device as this is small and
> specificaly tooled to fit and probably not able to get a larger one made
> for the purpose of AET testing.
>
> Thanks as always
> Mike
>
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> Charles River Laboratories -
> https://www2.criver.com/l/60962/2020-03-27/h6jqv6
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> Veltek Associates, Inc - http://www.sterile.com
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> Microbiologics, Inc. - http://www.microbiologics.com
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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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