* * * INSIGHT * * *

Standard Leak Rate for a Freeze-Dryer

by

Thomas A. Jennings, Ph.D.

ABSTRACT: I am a firm believer that the lyophilization process and its associated equipment are certainly in need of standards. For example, there is a real need for a standard pressure (vacuum) unit. It is about time that the industry abandon such units as bar, microns,  mmHg, Torr and completely reject the use of  such units as % vacuum. I strongly urge the industry to adopt Pascal as the standard pressure unit.

It would also make sense if the equipment manufacturers could agree on standard shelf sizes for a given size freeze-dryer.  Such a latter standard would  assist in making design and conduction of freeze-dryers much more compatible. But is does come as a surprise that there is an attempt to institute a standard leak rate for freeze-dryers. While there is ample information regarding the nature of leaks in freeze-dryers [1-6], it is the objective of INSIGHT to consider the merits of defining a standard leak rate that would be applicable to all freeze-dryers.

Volume 3 Number 6                                                                                            June 2000

3 Pages          6  References          No Figures

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