Freeze drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulations that impact lyophilization practices. This new edition of Freeze Drying/ Lyophilization of Pharmaceutical and Biological Products addresses these changes with updated and new chapters on emerging developments in lyophilization technology, research, and industry procedures. Providing both a scientific and industrial perspective, this comprehensive text is a valuable resource for all those who use freeze drying technology.

Opening Speech of the ICEDIVE 84 Conference by His Royal Highness Prince Bertil of Sweden I am very pleased to be invited to open the International Conference ICEDIVE 84, dealing with medical and technical problems of diving and related underwater activities in arctic conditions. Until recent times, the arctic was considered astrange and remote area of minor importance. However, in a world with diminishing natural resources, arctic areas have become a region of global importance because of their enormous resources and strategie position. Certain experts believe that more than 50% of oil reserves are "sleeping" in these northern areas which are cold, harsh and hostile to man. Operations in arctic areas are extremely difficult, expensive, and demand high levels of technical, scientific and physiological achievement. One should recall for example, that Alaskan oil investment onIy became economically viable after the 1973-1974 price explosion. Recent political/military troubles in the Gulf have increased interest in the development of polar resources. This conference is unique as it is the first time that medical and technical specialists interested in the problem of diving in arctic conditions have met in an international forum. Development of the arctic resources is a matter of international urgency, and it pleases me that scientists from the USA, Canada, the USSR, Australia and Europe have gathered here in Stockholm to present their experience and to discuss problems in this field.

Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD (R) packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.