Aseptic Pharmaceutical Manufacturing II

Aseptic Pharmaceutical Manufacturing II
Title Aseptic Pharmaceutical Manufacturing II PDF eBook
Author Michael J. Groves
Publisher CRC Press
Pages 544
Release 2020-08-14
Genre Medical
ISBN 1000161676

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Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.

Aseptic Pharmaceutical Manufacturing II

Aseptic Pharmaceutical Manufacturing II
Title Aseptic Pharmaceutical Manufacturing II PDF eBook
Author Michael J. Groves
Publisher CRC Press
Pages 544
Release 1995-05-31
Genre Medical
ISBN 9780935184778

Download Aseptic Pharmaceutical Manufacturing II Book in PDF, Epub and Kindle

Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.

Practical Aseptic Processing

Practical Aseptic Processing
Title Practical Aseptic Processing PDF eBook
Author Jack Lysfjord
Publisher Parenteral Drug Association
Pages 405
Release 2009
Genre Drugs
ISBN 9781933722283

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Advanced Aseptic Processing Technology

Advanced Aseptic Processing Technology
Title Advanced Aseptic Processing Technology PDF eBook
Author James Agalloco
Publisher CRC Press
Pages 495
Release 2016-04-19
Genre Medical
ISBN 1439825440

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The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies

Sterile Manufacturing

Sterile Manufacturing
Title Sterile Manufacturing PDF eBook
Author Sam A. Hout
Publisher CRC Press
Pages 206
Release 2021-07-05
Genre Technology & Engineering
ISBN 1000406091

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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.

Sterile Drug Products

Sterile Drug Products
Title Sterile Drug Products PDF eBook
Author Michael J. Akers
Publisher CRC Press
Pages 517
Release 2016-04-19
Genre Medical
ISBN 1420020560

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Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
Title Validation of Pharmaceutical Processes PDF eBook
Author James P. Agalloco
Publisher CRC Press
Pages 762
Release 2007-09-25
Genre Medical
ISBN 1420019791

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Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va