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By Louis Rey

Completely acquainting the reader with freeze-drying fundamentals-including water homes serious to the method and mechanisms and technique of protein stabilization-Freeze-Drying/Lyophilization of Pharmaceutical and organic items, moment version carves sensible directions from the very most recent theoretical study, applied sciences, and commercial procedures-ensuring the simplest execution of steps from closure education and regulatory keep an eye on of goods to gear sterilization and approach validation.

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Additional resources for Freeze-Drying Lyophilization of Pharmaceutical and Biological Products, Second Edition, (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs)

Sample text

Thus, we are inclined to believe that the application of this technique to numerous systems presenting low-temperature evolutions such as sugar, polymers, and alcohols might be of interest. This is one of the reasons why we could not resist applying lowtemperature thermoluminescence to dilutions of the type used by homeopathy. Indeed, the scientists who have been working in this field have often 18 Rey Figure 14 (a) Thermoluminescence emission spectra of D2O irradiated by gamma rays (10 kGy) at À196 C and reactivated by rewarming.

III. OPERATING PRESSURE Numerous books and papers have been written on the physics of primary and secondary drying. In the present book, G. W. Oetjen reviews quite extensively the different parameters involved. Therefore, it is pointless deal with this topic in the introductory chapter. However, we would like to stress one single point that has not always been clearly understood: the central role of the operating pressure. Indeed, as we have shown in Figure 2, freezedrying deserves an accurate and continuous control of the pressure in the chamber during the whole operation.

As a consequence, the temperature of the heaters could be substantially reduced, which prevented melting of the still-frozen core and/ or scorching of the already existing dry layer. Monitoring and control of this pressure is still an essential part of the process, and they can be geared to the intrinsic properties of the product such as its temperature or, better, its electric impedance [4–6,12]. At any rate, during this whole sublimation period, the vacuum level is the master key to the heat transfer and can help to ‘‘rescue’’ a product that is becoming too hot and starting to soften dangerously.

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