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April 2017

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Tue, 4 Apr 2017 12:15:24 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (251 lines)
Matt I replace my EpiPens every 2 years and monitor the color change in the
EpiPen window.

Yes I was aware of the recall and check if my current EpiPens were involved.

As someone who has experienced anaphylactic shock it certainly a medical
emergency requiring a ER visit.

On Mon, Apr 3, 2017 at 3:32 PM, Rhodes, Matthew <[log in to unmask]>
wrote:

> Hi Tony,
>
> I posed the same question to my doctor when the prices increased.  I was
> told by him that as long as the solution in the window remains clear, the
> dose is still good.  I am not a doctor, I do not work in the pharma
> industry nor have I had to use one that has passed the expiration date, so
> I have no concrete evidence or data to back up his claim.  With less
> expensive alternatives hitting the market as well as manufacturers
> discounts being offered for the EpiPen, this might be one of those items
> best not left to chance.
>
> On a side note and in case you haven't heard, there have been recalls
> issued for malfunctioning devices.  Please see  https://www.fda.gov/
> NewsEvents/Newsroom/PressAnnouncements/ucm550170.htm to check if yours
> are on the list.  Mylan is offering free replacements to affected lot #'s.
>
> Best,
> Matt
>
> -----Original Message-----
> From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]
> MICROBIOLOGYNETWORK.COM] On Behalf Of Aoife Brosnan
> Sent: Monday, April 03, 2017 11:43 AM
> To: [log in to unmask]
> Subject: Re: [PSDGLIST] EpiPen Stability
>
> 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" <michael.barron@
> qualitychemlabs.com>
> 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 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.
> >
>
> =================================
> 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.
>



-- 
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 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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