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STERILE PROCESSING OF PHARMACEUTICAL PRODUCTS : engineering practice, validation, and... compliance in regulated environments by Hout, Sam A. is a nonfiction available to read on EtoBox.

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Describes the methodologies and best practices of the sterile manufacture of drug products Thoroughly trained personnel and carefully designed, operated, and maintained facilities and equipment are vital for the sterile manufacture of medicinal products using aseptic processing. Professionals in pharmaceutical and biopharmaceutical manufacturing facilities must have a clear understanding of current good manufacturing practice (cGMP) and preapproval inspection (PAI) requirements. Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments provides up-to-date coverage of aseptic processing techniques and sterilization methods. Written by a recognized expert with more than 20 years of industry experience in aseptic manufacturing, this practical resource illustrates a comprehensive approach to sterile manufacturing engineering that can achieve drug manufacturing objectives and goals. Topics include sanitary piping and equipment, cleaning and manufacturing process validation, computerized automated systems, personal protective equipment (PPE), clean-in-place (CIP) systems, barriers and isolators, and guidelines for statistica

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Author

Hout, Sam A.

Publisher

Wiley & Sons, Limited, John

Published

2022

Language

EN

ISBN

9781119802341

Category

nonfiction

Subjects

Engineering, Science, Chemistry