Publications and Presentations on
Moisture in Closures
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The following is a list of publications written by Thomas A.
Jennings on the moisture of elasomer closures used in the lyophilization
process.
Assessment
of Risk Factors of the Container-Closure System for PAT Guidelines
This paper is based on a presentation given at the India Chapter Workshop of
the ISL-FD Held in Bangalore, India during November 19 and 20, 2005. The
document is in a .pdf format and will open up in Adobe Acrobat, if installed.
Out in the
Cold - A reprint of a paper that appeared in the Autumn 2006 issue of
PMPS.
While the PAT Guidelines are indeed revolutionary and welcome to those
manufacturing pharmaceuticals, nonetheless, PAT really has its foundation in
the concept of Six Sigma that has been widely used with great success in the
electronics industry for many years. The term sigma refers to standard
deviation which is how far a measured value varies from the mean or the desired
value. The underlying philosophy of Six Sigma is that the manufacturing process
is so well controlled that the number of defects would only amount to 3.4 parts
per million (ppm). However if one uses a three sigma approach to the production
then the output would be 99.73% and that would translate into defects or
failures of the order of 2,700 ppm. Once a pharmaceutical company demonstrates
its manufacturing process has achieved the six sigma goal then real time
release of manufactured pharmaceutical products will no longer be hypothetical
but become a reality. Read more in
OUT in the Cold.
The document is in a .pdf format and will open up in Adobe Acrobat, if
installed.
Managing the Risk of Residual
Moisture on Lyophilized Products from Elastomer Closures.
Abstract: This paper (submitted for publication) examines means for managing
the risk that the moisture from elastomer closures may have in producing poor
lyophilized products. Assessment of the risk will be based on the frequency
distribution of the capacitance of the closures. The importance that the sample
size will have on confidence interval and its effect on managing the risk will
be examined. Other key factors that must be taken into account are (a), post
lyophilization treatment of the closures and (b), mass of the lyophilized cake.
Sound management of the risk of a poor lyophilized product from the residual
moisture of closures requires a reliable data base. The document is in a .pdf
format and will open up in Adobe Acrobat, if installed.