* * * INSIGHT * * *

IQ of Freeze-Dryer - Part B

ABSTRACT: The present INSIGHT is a continuation of a series (Vol. 2 No. 3,  Vol. 2 No. 5,  Vol. 2 No. 7, Vol. 2 No. 9 and Vol. 2 No. 11) that has addressed the validation of the lyophilization process and its associated equipment and instrumentation in a rather un-conventional manner. The attempt here is to take what could be a rather dry topic and present various aspects in a format that brings out some key issues that may often be overlooked but in a fashion that some may find entertaining. I would like to emphasize that I do not feel that what is presented is represented of the total validation process but just points out what may  possibly be overlooked and should be considered in any  validation study.

This issue is a continuation of the IQ of the freeze-dryer. Since in the previous issue it was pointed out that the freeze-dryers were new and just installed, the IQ is essential in establishing a baseline for the equipment. Thus it is imperative that any future changes or replacement of parts in  the equipment be in accordance with the original design and construction of the dryer. If a direct substitute of a component cannot be made then an impact study must be made to show that such a substitution did not result in a significant process change.

Volume 3 Number 1                                                                                    January 2000

11 Pages          No  References          No Figures

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