Pharmaceutical Manufacturing

Written by an expert in the industry, this text addresses the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality. The author offers a clear and concise review of particle populations and their control in stab..

This book covers the principles of cryopreservation as they relate the preservation of viable cells and cell materials being developed for biopharmaceutical applications. Topics include: the principles of freezing and thawing cells, physiochemical phenomena, process and system design options, method..

While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages. _x005F_x005F_x000D_ _x005F_x00..

While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages. _x005F_x000D_ _x005F_x000D_ Ha..

Focusing specifically on the FDA documentation requirements, How to Develop and Manage Qualification Protocols for FDA Compliance provides readers with concrete guidance on how to develop and manage qualification protocols and their associated documentation to ensure that their companies are not at ..

Interactions between drug particulates are crucial in determining drug dispersion and deaggregation, and ultimately delivery efficiency. This book combines principles established in surface and colloidal chemistry with pharmaceutical powder technology. It discusses some of the factors affecting part..

Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. The author covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applie..

This unique reference examines the modern pharmaceutical compacting techniques used to form tablets out of powders-describing the physical structure of pharmaceutical compacts, the bonding phenomena that occur during powder compaction, and the compression mechanisms of pharmaceutical particles...

Pharmaceutical Process Engineering, Second Edition is the ideal introductory text for pharmaceutical scientists and technologists._x005F_x000D_ With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to ..

Pharmaceutical Process Scale-Up, Third Edition provides an excellent insight into the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, ..

A complete resource on the coating of tablets, capsules, and other solid dosage forms of therapeutic agents, this book begins with a full discussion of the primary processes and rationale for coating and goes on to cover methodologies, formulations, processing methods, equipment, and cleaning. It ex..

This unique reference provides the first systematic coverage available in a single-source volume on the application of materials science techniques to the pharmaceutical field-offering a comprehensive program for the physical characterization of raw materials, drug substances, and formulated product..