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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Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
Title Principles of Parenteral Solution Validation PDF eBook
Author Igor Gorsky
Publisher Academic Press
Pages 300
Release 2019-11-27
Genre Medical
ISBN 012809446X

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Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. - Discusses international and domestic regulatory considerations in every section - Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs - Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Handbook of Aseptic Processing and Packaging

Handbook of Aseptic Processing and Packaging
Title Handbook of Aseptic Processing and Packaging PDF eBook
Author Jairus R. D. David
Publisher CRC Press
Pages 389
Release 2012-11-15
Genre Technology & Engineering
ISBN 1439807205

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Since publication of the first edition of this book, Aseptic Processing and Packaging of Food, significant changes have taken place in several aseptic processing and packaging areas. These include changes in aseptic filling of nutritional beverages in plastic bottles; the popularity of value-added commodity products such as juice, concentrate, and

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

Practical Pharmaceutics

Practical Pharmaceutics
Title Practical Pharmaceutics PDF eBook
Author Yvonne Bouwman-Boer
Publisher Springer
Pages 873
Release 2015-08-24
Genre Medical
ISBN 3319158147

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This book contains essential knowledge on the preparation, control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation. From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacists to remind and focus them on the application of the medicines manufactured. The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and industries. Undergraduate as well as graduate pharmacy students will find knowledge and backgrounds in a fully coherent way and fully supported with examples.

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