This completely updated and enlarged third edition of the classic text adopts a practical approach to describe the fundamentals of freeze-drying, backed by many explanatory examples. Following an introduction to the fundamentals, the book goes on to discuss process and plant automation as well as methods to transfer pilot plant qualifications and process data to production. An entire section is devoted to a large range of different pharmaceutical, biological, and medical products. New to this edition are chapters on antibodies, freeze-dry microscopy, TEMPRIS, microwave freeze-drying, spray freeze-drying, and PAT. Their many years of experience in freeze-drying enable the authors to supply valuable criteria for the selection of laboratory, pilot and production plants, discussing the advantages, drawbacks and limitations of different plant designs. Alongside guidelines for the evaluation and qualification of plants and processes, the author also includes a troubleshooting section.
Many modern medicines, for example blood derivatives, vaccines, cytostatic drugs, and antibiotics, but also soluble coffee, have one thing in common: freeze-drying is the best method of transforming the perishable substances into a form that keeps well and allows the substances to be stored before being returned almost to their natural state. This book describes the rules of freeze-drying. The critical process data is not just presented theoretically but explained with regard to practical examples. Application of freeze-drying processes is the main emphasis of this book. Many years of experience in the freeze-drying business allow the author to present valuable criteria for the selection of laboratory or industrial plants. Evaluation of the latest publications guarantees state-of-the-art coverage of information. Even modern topics, e.g., validation of processes or estimation of acceptable variances from preset values, are taken into account. These valuable tips make the book indispensable for everybody working in the freeze-drying business.