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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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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