* * * INSIGHT * * *

Moisture Determination in Lyophilized or Freeze-dried Products

by

Thomas A. Jennings, Ph.D.

Regardless of your application, if you are using a lyophilization or freeze-drying process you are most likely attempting to increase the stability or shelf-life of a substance by means of reducing the moisture content to levels that will no longer support biological activity or chemical reactions. Without question, each time that you perform the process you are faced with three very fundamental questions, i.e., (1), is there a high degree of certainty that the residual moisture content in all of the product containers is within some well defined limits prior to their removal from the dryer?; (2), how do you know that the residual moisture in all of the final packaged product is within some defined limits? and (3), during storage at some prescribed environment, will all the residual moisture in the product remain within the limits? Admittedly, these are indeed tough questions to answer and while this INSIGHT may not provide any direct answers to their solution, nonetheless, it is worth while to discuss them and hope that perhaps the future may hold the answer to some or even all of the questions.

Volume. 5  Number 4                                                                               April 2002

4 Pages          3 References           0 Figures

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