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April 2015

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Subject:
From:
Katrina Elia <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 2 Apr 2015 11:23:55 +0000
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Patrick,

You are right there is no regulations for this type of bottle, However the best practice I have seen and went through several inspections without a thought is the following: 
Hospital or pharmacy size multiple use bottles general contain a large number of individual units. We would take the normal amount of sample required for the full study in a few bottles as possible and do one of the following depending on the number in the bottle and the number need for testing.

1-Open one container for all of the pull stations thus the container was opened throughout its shelf life continually. (generally these containers had upward of 500 to 1000 units)
2- Open several containers at each pull station and remove an equal number of units from each container over the study. Opening the same containers each time removing the same number. (example: 10 bottles of 50 units each. 30 are needed for testing. we would take 5 from each of 12 bottles at each of the pull times)  

I hope this helps. I am sure there are many other ways to show that opening the container multiple times overs the expiry period is acceptable as well..

Katrina Elia




-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Forenzo, Patrick
Sent: Wednesday, April 01, 2015 7:48 AM
To: [log in to unmask]
Subject: [PSDGLIST] In Use Test for solids

Can anyone share their program for in use test of solids in multiple use packs (ie HDPE bottles containing 30 units)- there is no clear guidance on how to perform the test and I am looking for some sort of industry standard companies are using- for example remove 1 tablet a day for 20 days (leaving 10 tablets in the bottle) , store for an additional 10 days opening the bottle once a day- (total test time 30 days) and then test the remaining samples or remove 1 tablet a day from bottle a and move into bottle b (empty) until all 30 units have been moved from bottle a to bottle b- perform the testing on the units in bottle b


Patrick Forenzo
Senior Fellow / Stability Expert
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
USA

Phone     +1  862 7786690
Cell        + 1  201 7047992
Fax         +1  973 7812019
[log in to unmask]<mailto:[log in to unmask]>
www.novartis.com<http://www.novartis.com/>



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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.

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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.

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

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

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