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April 2017

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Subject:
From:
Emil Friedman <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 13 Apr 2017 22:29:10 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (140 lines)
Contact the manufacturer.  13C might or might not drop it below some sort
of temperature at which something drops out of solution .  Consider what
might happen out in the boonies if your EpiPen fails to work properly.  But
don't hold your breath (pun intended); they may have data showing the 5C is
bad but may not have tested it at 13C.  Stability studies are expensive to
do.

-------------------------------------------
Emil M Friedman, PhD
880 Salem Ave
Hillside, NJ 07205
732-227-5942 (land line at work)
216-287-0821 (cell)
908-355-8319 (home phone number)
[log in to unmask]
[log in to unmask]
http://www.statisticalconsulting.org

On Mon, Apr 3, 2017 at 7:31 AM, 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
>
> =================================
> The nature of this service is to provide a medium for communication.  The
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> discussions are not necessarily those of The Microbiology Network, Inc.,
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>
> ------------------
> The PSDGList (http://microbiol.org/psdglist.htm) is operated from The
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>
>
> 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.
>

=================================
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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