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April 2015

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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 9 Apr 2015 12:34:21 -0400
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Patrick,
 
There is a 2001 European guidance that may be helpful.
 
NOTE FOR GUIDANCE ON
IN-USE STABILITY TESTING OF HUMAN MEDICINAL  PRODUCTS
CPMP/QWP/2934/99
 
Regards,
Stan Alekman
 
 
 
 
In a message dated 4/8/2015 10:13:41 P.M. Eastern Daylight Time,  
[log in to unmask] writes:

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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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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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.

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.


=================================
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.

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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