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April 2017

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Subject:
From:
Aoife Brosnan <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Mon, 3 Apr 2017 16:42:45 +0100
Content-Type:
text/plain
Parts/Attachments:
text/plain (137 lines)
Hi Tony,

I believe the compound remains stable at 2-8c, but it is the stability of
the device that holds the epinephrine dose that may not be guaranteed when
refrigerated. Storage at 2-8 might impact the triggering mechanism and
prevent injection of the dose.
This is just my opinion based on working with stability of large molecule
devices, I don't have any direct experience of epipen stability.

Regards,
Aoife

Stability Scientist, Analytical Development,
Janssen Sciences UC

On 3 Apr 2017 4:25 PM, "Michael Barron" <[log in to unmask]>
wrote:

> Hi Tony,
>
> Not familiar specifically with EpiPen stability but assuming the 5C label
> warning is based on scientific evidence I would start with using a wine
> cooler.  Designed for operating @ ~13C.  Everone has one...right? :)
>
> A quick message from my phone.
> Thanks,
> Michael
> ________________________________________
> From: Pharmaceutical Stability Discussion Group [[log in to unmask]
> MICROBIOLOGYNETWORK.COM] on behalf of Tony Cundell [[log in to unmask]]
> Sent: Saturday, April 01, 2017 1:59 PM
> To: [log in to unmask]
> Subject: [PSDGLIST] EpiPen Stability
>
> I carry an EpiPen when hiking or visiting botanical gardens as I am highly
> allergic to bee stings.
>
> With the short expiration dating of EpiPens I have to replace them
> annually.Their cost have gone through the roof!
>
> Although the product labeling warns against refrigeration could I
> refrigerated the device when not needed and put it in my hiking bag when
> hiking. With this strategy I might extent the shelf life to 2 or 3 years.
>
> Any comments
> --
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [log in to unmask]
> Phone: 914 725-3947
> Cell: 914 841-0074
>
> =================================
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> and
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> =================================
> 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 Microbiology Network, Inc.,
> the PSDG, or the sponsors of the list.
>
> ------------------
> The PSDGList (http://microbiol.org/psdglist.htm) is operated from The
> Microbiology Network (http://www.microbiol.org) and 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.
>
>
> Avista Pharma Solutions - http://www.avistapharma.com/
>    Comprehensive testing and CMC services organization
>    Analytical and Microbiology support to early stage API and drug product
> development and manufacturing.
>
>
> BahnsonEnvironmental Specialties - http://www.eschambers.com/
>    Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers
> and
>    Ultra Low Storage Chambers with Complete Validation, Maintenance &
> Calibration
>
> Cincinnati Sub-Zero - http://www.cszindustrial.com/
>     Provides a large selection of environmental chambers from benchtop,
> reach in to walk-in
>     rooms along with chambers for freeze/thaw, temperature cycling
> applications.
>

=================================
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 Microbiology Network, Inc., the PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and 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.


Avista Pharma Solutions - http://www.avistapharma.com/
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.


BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - http://www.cszindustrial.com/
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.

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