* * * INSIGHT * * *

Validation Part 1D - Product Properties

By

Thomas A. Jennings, Ph.D.

ABSTRACT: The last three issues of INSIGHT deal with the validation of the lyophilization process based on the knowledge that the formulation was reproducible from batch to batch. The lyophilization process was defined as process parameters (shelf temperature and chamber pressure) and the product temperature being maintained between defined limits during the freezing. primary drying and secondary drying processes. A fourth parameter time became important during the primary drying to ensure that all of the product containers had completed the drying process. However, by using the purge method (described in Vol. 1 No.7) for the secondary drying, the time dependence could be replaced by a series of gas purges that would ensure uniform drying of all the product provided the product temperatures were within a specific range of values.

In this issue we will take up the validation of the lyophilization process with respect to product properties. The main purpose of this insight is to demonstrate that as long as the process parameters were within specified temperature and pressure ranges and product temperature also fell within a defined range the resulting product properties would fall within an acceptable range of values. This issue will also take up the question of the batch size required for a validation of the lyophilization process. With this in mind we join our two heroes several weeks later as they hurry through the hall carrying hot coffee in one hand and donuts, pastry and muffins wrapped in napkins in the other.

Volume 2 Number 9                                                                                  September 1999

6 Pages          1  References          No Figures

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