Sam A. Hout's Books

Advanced Manufacturing Operations Technologies

Principles, Applications, and Design Correlations in Chemical Engineering Fields of Practice

By: Sam A. Hout

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Advanced Manufacturing Operations Technologies

Principles, Applications, and Design Correlations in Chemical Engineering Fields of Practice

By: Sam A. Hout

This book discusses and chronicles various types of manufacturing processes, including casting and molding, machining, joining, shearing, and forming. It refers to repetitive, discrete job shop process manufacturing (continuous) and process manufacturing (batch). It also offers detailed examples from the nuclear, electronic, plastics, adhesives, inks, packaging, chemical, and pharmaceutical industries. Advanced Manufacturing Operations Technologies: Principles, Applications, and Design Correlations in Chemical Engineering Fields of Practice fills the gap in the connection between production and regulated applications in several industries. It highlights established concepts and provides a new, fresh outlook by concentrating on and creating linkages in the implementation of practices in manufacturing and safe, clean energy systems. Case studies for the overall design, installations, and construction of manufacturing operations in various industries as well as the standard operating procedures are offered. The book also discusses the correlation between design strategies including step-by-step processes to ensure the reliability, safety, and efficacy of products. The fundamentals of controlled techniques, quality by design, risk assessment, and management are covered in support of operations applications and continuous improvement. This comprehensive book is helpful to all professionals, students, and academicians in many scientific disciplines that utilize fundamental principles of chemical engineering. It is engineering-driven and will be of use to those in industrial and manufacturing, chemical, biochemical, mechanical engineering, and automated control systems fields.

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Page Count

321

Publisher

CRC Press

Published Date

ISBN 10

1000903931

ISBN 13

9781000903935

Manufacturing of Quality Oral Drug Products

Processing and Safe Handling of Active Pharmaceutical Ingredients (API)

By: Sam A. Hout

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Manufacturing of Quality Oral Drug Products

Processing and Safe Handling of Active Pharmaceutical Ingredients (API)

By: Sam A. Hout

This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products. This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics. Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.

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Page Count

213

Publisher

CRC Press

Published Date

ISBN 10

1000603423

ISBN 13

9781000603422

Sterile Manufacturing

Regulations, Processes, and Guidelines

By: Sam A. Hout

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Sterile Manufacturing

Regulations, Processes, and Guidelines

By: Sam A. Hout

This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.

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Page Count

148

Publisher

CRC Press

Published Date

ISBN 10

1000406121

ISBN 13

9781000406122

Sterile Processing of Pharmaceutical Products

Engineering Practice, Validation, and Compliance in Regulated Environments

By: Sam A. Hout

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Sterile Processing of Pharmaceutical Products

Engineering Practice, Validation, and Compliance in Regulated Environments

By: Sam A. Hout

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 statistical procedure. Offering authoritative guidance on the key aspects of sterile manufacturing engineering, this volume: Covers fundamentals of aseptic techniques, quality by design, risk assessment and management, and operational requirements Addresses various regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH Provides techniques for systematic process optimization and good manufacturing practice Emphasizes the importance of attention to detail in process development and validation Features real-world examples highlighting different aspects of drug manufacturing Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments is an indispensable reference and guide for all chemists, chemical engineers, pharmaceutical professionals and engineers, and other professionals working in pharmaceutical sciences and manufacturing.

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Page Count

372

Publisher

John Wiley & Sons

Published Date

ISBN 10

1119802326

ISBN 13

9781119802327

Sterile Manufacturing

Regulations, Processes, and Guidelines

By: Sam A. Hout

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Sterile Manufacturing

Regulations, Processes, and Guidelines

By: Sam A. Hout

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Solve jigsaw puzzle

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Page Count

148

Publisher

CRC Press

Published Date

ISBN 10

1000406121

ISBN 13

9781000406122

Sterile Processing of Pharmaceutical Products

Engineering Practice, Validation, and Compliance in Regulated Environments

By: Sam A. Hout

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Sterile Processing of Pharmaceutical Products

Engineering Practice, Validation, and Compliance in Regulated Environments

By: Sam A. Hout

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Solve jigsaw puzzle

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Page Count

372

Publisher

John Wiley & Sons

Published Date

ISBN 10

1119802326

ISBN 13

9781119802327

Book's by Sam A. Hout

Advanced Manufacturing Operations Technologies

Advanced Manufacturing Operations Technologies

Manufacturing of Quality Oral Drug Products

Manufacturing of Quality Oral Drug Products

Sterile Manufacturing

Sterile Manufacturing

Sterile Processing of Pharmaceutical Products

Sterile Processing of Pharmaceutical Products

Sterile Manufacturing

Sterile Manufacturing

Sterile Processing of Pharmaceutical Products

Sterile Processing of Pharmaceutical Products

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