* * * INSIGHT * * *

The Core to a Lyophilization Problem

By

Thomas A. Jennings, Ph.D.

ABSTRACT: While preparing the manuscript for the soon to be published book on lyophilization, I was struck with the dearth of information associated with the possibility of coring of the closure during reconstitution, i.e., the production of particulate matter in the solution as a result of the insertion of the needle through the closure. The question that comes to mind is “Was the lack of publications on this topic a result of the nonexistence of such a problem or have we, as an industry, just ignored such a problem?” I for one, would hope that the answer would favor the former rather than the latter. It is therefore the objective of this issue of INSIGHT, to examine a), the current acceptable limits on coring;  b),  those conditions that favor coring;  c),  methods for measuring the coring of a closure;  d) a possible remedy to such a potential problem and e), promote a general discussion on this topic that will enlighten all of us with respect to this topic.

Volume 2 Number 4                                                                                              April 1999

4 Pages          3  References          No Figures

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