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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 27 Aug 2014 14:34:19 -0400
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Chad,
 
I can only answer your question from a statistical perspective. If there  
are other relevant factors, others will address them.
 
Were you to collect and test 3 samples representative of the lot and all  
pass the ingress test, you could make the claim: With 90% confidence,  the 
failing vial level is below 54% of the lot (4,860 vials). For 5 test  vials, 
all passing: With 90% confidence, the failing level is below 37%  (3,3330). 
With 7 passing test vials: With 90% confidence, the failing level  is below 
28% (2,520 vials); with 10 passing test vials: with 90%  confidence, the 
failing level is below 20% (1,800 vials).
 
The phrase, failing vial level, represents uncertainty, not failing vials.  
The sample size was insufficient to comment on this number of  vials. 
 
I believe PDA has a Technical Report on container closure integrity. It may 
 have discussion and recommendations for sample size.
 
Best Wishes,
Stan Alekman
 
Stanley L. Alekman, PhD
S. L. Alekman Associates Inc. 
 
 
In a message dated 8/27/2014 8:26:06 A.M. Eastern Daylight Time,  
[log in to unmask] writes:

I  believe this question has been asked before, but I would still like to 
clarify  a few things.  I am trying to determine how many vials to analyze on 
 stability through blue dye ingress analysis on a lot of material which has 
a  9,000 vial lot size.  What is a statistically sound number of vials to  
analyze when the product is still in clinical trials and the material is 
quite  costly?  Can you perform CCI testing on as little as three vials, one  
from each the beginning, middle, and end of the lot when testing is  
scheduled?  Is there a specific confidence interval which must be met for  this type 
of testing, and is it expected that the number of vials tested is  adjusted 
for each lot size of vials manufactured? Any help will be greatly  
appreciated.

Thanks,

Chad

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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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