MY understanding from the FDA guidance that you use 20 vials as in a
sterility test

Tony Cundell


On Tue, Aug 26, 2014 at 8:11 PM, Chad Genson <[log in to unmask]> wrote:

> 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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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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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.