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Author: Jack Lysfjord
Publisher: Parenteral Drug Association
ISBN: 9781933722283
Category : Drugs
Languages : en
Pages : 405
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Book Description
Author: Jack Lysfjord
Publisher: Parenteral Drug Association
ISBN: 9781933722283
Category : Drugs
Languages : en
Pages : 405
Get Book Here
Book Description
Author: James Agalloco
Publisher: CRC Press
ISBN: 1439825440
Category : Medical
Languages : en
Pages : 495
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Book Description
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
Author: Jairus R. D. David
Publisher: CRC Press
ISBN: 1439807205
Category : Technology & Engineering
Languages : en
Pages : 389
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Book Description
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
Author: Igor Gorsky
Publisher: Academic Press
ISBN: 012809446X
Category : Medical
Languages : en
Pages : 300
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Book Description
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
Author: Helmut Reuter
Publisher: CRC Press
ISBN: 1000153878
Category : Technology & Engineering
Languages : en
Pages : 230
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Book Description
Aseptic food processing has become important as a safe and effective method for the preparing and packaging of a variety of foods. This recent book, prepared by a team of European specialists, provides a detailed guide and reference to aseptic food processing technology. All aspects are presented systematically: principles, practice, equipment, applications, packages and packaging, quality control, and safety. All applicable food and beverage categories are examined. More than 130 photographs, diagrams, and other schematics illustrate equipment and their function and a variety of procedures. Tables and graphs provide important quantitative data in convenient form.
Author: Jairus R. D. David
Publisher:
ISBN: 9780367745974
Category : Food
Languages : en
Pages : 0
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Book Description
"Continuing its mission for those developing day-to-day procedures for aseptic processing and packaging applications, the third edition of this book features 6 new chapters and 6 new appendices providing practical information for industry. New chapters cover processing system and infrastructure design, Residence Time Distribution, and microbiology"--
Author: Michael J. Groves
Publisher: CRC Press
ISBN: 9780935184778
Category : Medical
Languages : en
Pages : 544
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Book Description
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.
Author: Michael J. Akers
Publisher: CRC Press
ISBN: 1420020560
Category : Medical
Languages : en
Pages : 517
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Book Description
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
Author: Sam A. Hout
Publisher: John Wiley & Sons
ISBN: 1119802326
Category : Technology & Engineering
Languages : en
Pages : 372
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Book Description
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.
Author: Sam A. Hout
Publisher: CRC Press
ISBN: 1000406091
Category : Technology & Engineering
Languages : en
Pages : 206
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Book Description
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.
