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May 2020

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Subject:
From:
Michael Barton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 14 May 2020 15:04:39 +0000
Content-Type:
text/plain
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text/plain (119 lines)
Tony,
this would be a new developed product for a single use that has a preservative as part of formulation, not from an existing multi use.

why would it need to be justified with FDA?
and if AET is required is this just as part of development work or for routine stability assessment?

Thanks
Mike
________________________________
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Tony Cundell <[log in to unmask]>
Sent: 14 May 2020 12:37
To: [log in to unmask] <[log in to unmask]>
Subject: Re: [PMFLIST] PET test

Adding a preservative system to a single-use nasal spray would need to be
justified to the FDA and when justified pass the USP <51> Antimicrobial
Effectiveness Test.

Do you share the same formulation with a multiple use products? Is that the
reason?

On Thu, May 14, 2020 at 1:27 AM Michael Barton <[log in to unmask]>
wrote:

> Hi All,
> if we have a single use non-sterile nasal spray that is preserved, does it
> require PET to be performed or is this only needed for multi dose product
> as this can be contaminated by patient during routine use?
>
> Thanks Mike
>
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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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