Freeze-Drying of Pharmaceutical and Food Products

by Tse-Chao Hua

Author	: Tse-Chao Hua
Publisher	: Elsevier
Total Pages	: 274
Release	: 2010-07-30
Genre	: Technology & Engineering
ISBN	: 1845697472

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Freeze-drying is an important preservation technique for heat-sensitive pharmaceuticals and foods. Products are first frozen, then dried in a vacuum at low temperature by sublimation and desorption, rather than by the application of heat. The resulting items can be stored at room temperature for long periods. This informative text addresses both principles and practice in this area.The first chapter introduces freeze-drying. The authors then review the fundamentals of the technique, heat-mass transfer analyses, modelling of the drying process and the equipment employed. Further chapters focus on freeze-drying of food, freeze-drying of pharmaceuticals and the protective agents and additives applied. The final chapter covers the important subjects of disinfection, sterilization and process validation.Freeze-drying of pharmaceutical and food products is an essential reference for food, pharmaceutical and refrigeration engineers and scientists with an interest in preservation techniques. It will also be of use to students in these fields. - Addresses the principles and practices used in this important preservation technique - Explains the fundamentals of heat-mass transfer analysis, modelling and the equipment used - Discusses the importance of disinfection, sterilization and process validation

Freeze Drying of Pharmaceutical Products

by Davide Fissore

Author	: Davide Fissore
Publisher	: CRC Press
Total Pages	: 212
Release	: 2019-10-24
Genre	: Medical
ISBN	: 042966401X

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Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.

Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded

by Louis Rey

Author	: Louis Rey
Publisher	: CRC Press
Total Pages	: 634
Release	: 2004-01-21
Genre	: Medical
ISBN	: 0203021320

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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® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.

Drying Technologies for Biotechnology and Pharmaceutical Applications

by Satoshi Ohtake

Author	: Satoshi Ohtake
Publisher	: John Wiley & Sons
Total Pages	: 366
Release	: 2020-02-10
Genre	: Medical
ISBN	: 3527802118

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A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.

Freeze-Drying

by Peter Haseley

Author	: Peter Haseley
Publisher	: John Wiley & Sons
Total Pages	: 434
Release	: 2018-05-07
Genre	: Science
ISBN	: 3527343067

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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.

Development and Manufacture of Protein Pharmaceuticals

by Steve L. Nail

Author	: Steve L. Nail
Publisher	: Springer Science & Business Media
Total Pages	: 479
Release	: 2012-12-06
Genre	: Medical
ISBN	: 1461505496

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In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.

Lyophilization of Pharmaceuticals and Biologicals

by Kevin R. Ward

Author	: Kevin R. Ward
Publisher	: Humana Press
Total Pages	: 437
Release	: 2018-12-13
Genre	: Medical
ISBN	: 9781493989270

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This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector – whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab. Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.

Handbook of Drying for Dairy Products

by C. Anandharamakrishnan

Author	: C. Anandharamakrishnan
Publisher	: John Wiley & Sons
Total Pages	: 340
Release	: 2017-02-03
Genre	: Technology & Engineering
ISBN	: 1118930517

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Handbook of Drying for Dairy Products is a complete guide to the field’s principles and applications, with an emphasis on best practices for the creation and preservation of dairy-based food ingredients. Details the techniques and results of drum drying, spray drying, freeze drying, spray-freeze drying, and hybrid drying Contains the most up-to-date research for optimizing the drying of dairy, as well as computer modelling options Addresses the effect of different drying techniques on the nutritional profile of dairy products Provides essential information for dairy science academics as well as technologists active in the dairy industry

Spray-Freeze-Drying of Foods and Bioproducts

by S. Padma Ishwarya

Author	: S. Padma Ishwarya
Publisher	: CRC Press
Total Pages	: 361
Release	: 2022-04-19
Genre	: Medical
ISBN	: 1000571459

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Spray-freeze-drying (SFD) is a synergistic drying technology that imbibes in it the merits of both spray drying and freeze-drying, whilst overcoming the limitations of these predecessor technologies. SFD produces uniquely powdered food and pharmaceutical products with porous microstructure and superior quality attributes. Owing to its atomization step and ultra-low-temperature operation, SFD is a competent drying technique for the production of valuable but sensitive bioactive components. Despite the costs and complexities involved, SFD has a competitive edge over the conventional drying techniques in providing distinctive product attributes. The applications of spray-freeze-drying in the area of food and bioproducts span across the product categories of instant food powders, dry flavors, active pharmaceutical ingredients, poorly water-soluble drugs, probiotics, proteins, enzymes and vaccines. Spray-Freeze-Drying of Foods and Bioproducts: Theory, Applications and Perspectives is the first exclusive title on this interesting drying technique. It provides a comprehensive understanding of the fundamentals of SFD and its food and pharmaceutical applications. The scope of this book, comprising 12 chapters, has been organizedunder four major headings: fundamentals of process-stages, applications with case-studies, recent advancements and the processing bottlenecks and solutions. Key Features Provides examples and case studies of nuances and intricacies associated with each stage of the spray-freeze-drying process Highlights the applications of spray-freeze-drying in the production of food products including soluble coffee, dairy powders, probiotics and flavors Serves as a ready-reckoner of characterization methods for spray-freeze-dried products Contains 200+ illustrations and tabulations The contents of this book are organized to cater to the knowledge needs of students, academicians, researchers and professionals in the food and pharmaceutical industry.