* * * INSIGHT * * *

Validation Part IA - Lyophilization Process - Freezing

By

Thomas A. Jennings, Ph.D.

ABSTRACT: A number of subscribers have suggested the topic of  validation as an issue of INSIGHT. This is part IA of a series of INSIGHT that involves the validation of the lyophilization process and its associated equipment and instrumentation. In order to make the reading easier and yet still provide the reader with an understanding of the rationale or logic involved, I have once again called on the Novice who was introduced in issue Volume 1 No. 8. The main reason for selecting this format is that through his questions the Novice reveals key points about the validation process. A second reason is that I have just completed a book on the subject of lyophilization and I find this style of writing a welcome relief. So we begin our story.

Volume 2 Number 3                                                                                       March 1999

9 Pages          2  References          No Figures

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