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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:
Thu, 14 May 2020 08:37:46 -0400
Content-Type:
text/plain
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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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> 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

------------------
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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