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Author : Jack Lysfjord
Publisher : Parenteral Drug Association
ISBN 13 : 9781933722283
Total Pages : 405 pages
Book Rating : 4.7/5 (222 download)
Download or read book Practical Aseptic Processing written by Jack Lysfjord and published by Parenteral Drug Association. This book was released on 2009 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : James Agalloco
Publisher : CRC Press
ISBN 13 : 1439825440
Total Pages : 495 pages
Book Rating : 4.4/5 (398 download)
Download or read book Advanced Aseptic Processing Technology written by James Agalloco and published by CRC Press. This book was released on 2016-04-19 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 1439807205
Total Pages : 389 pages
Book Rating : 4.4/5 (398 download)
Download or read book Handbook of Aseptic Processing and Packaging written by Jairus R. D. David and published by CRC Press. This book was released on 2012-11-15 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 012809446X
Total Pages : 300 pages
Book Rating : 4.1/5 (28 download)
Download or read book Principles of Parenteral Solution Validation written by Igor Gorsky and published by Academic Press. This book was released on 2019-11-27 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 1000153878
Total Pages : 230 pages
Book Rating : 4.0/5 (1 download)
Download or read book Aseptic Processing of Foods written by Helmut Reuter and published by CRC Press. This book was released on 2020-10-28 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 9780367745974
Total Pages : 0 pages
Book Rating : 4.7/5 (459 download)
Download or read book Handbook of Aseptic Processing and Packaging written by Jairus R. D. David and published by . This book was released on 2022-08 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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 13 : 9780935184778
Total Pages : 544 pages
Book Rating : 4.1/5 (847 download)
Download or read book Aseptic Pharmaceutical Manufacturing II written by Michael J. Groves and published by CRC Press. This book was released on 1995-05-31 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Sam A. Hout
Publisher : John Wiley & Sons
ISBN 13 : 1119802326
Total Pages : 372 pages
Book Rating : 4.1/5 (198 download)
Download or read book Sterile Processing of Pharmaceutical Products written by Sam A. Hout and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Michael J. Akers
Publisher : CRC Press
ISBN 13 : 1420020560
Total Pages : 517 pages
Book Rating : 4.4/5 (2 download)
Download or read book Sterile Drug Products written by Michael J. Akers and published by CRC Press. This book was released on 2016-04-19 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : CRC Press
ISBN 13 : 1000406091
Total Pages : 206 pages
Book Rating : 4.0/5 (4 download)
Download or read book Sterile Manufacturing written by Sam A. Hout and published by CRC Press. This book was released on 2021-07-05 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Karen Davis
Publisher : Elsevier Health Sciences
ISBN 13 : 0323292194
Total Pages : 157 pages
Book Rating : 4.3/5 (232 download)
Download or read book Sterile Processing for Pharmacy Technicians - E-Book written by Karen Davis and published by Elsevier Health Sciences. This book was released on 2013-09-27 with total page 157 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering aseptic technique and how to prepare sterile products, Sterile Processing for Pharmacy Technicians ensures safety, accuracy, and correctness of medications. Reflecting American Society of Health System Pharmacists (ASHP) competencies, this comprehensive book provides principles and guidelines, laboratory exercises, and hands-on practice with actual institutional orders. Written by expert pharmacy technician educator Karen Davis, Sterile Processing for Pharmacy Technicians also provides checklists that map to ASHP competencies! Complete coverage of USP guidelines, basic aseptic manipulations, and working with IVs prepares you for institutional externships and for practice. Unique! ASHP competency checklists allow accurate documentation of competencies. Lab activities allow you to perform basic, hands-on aseptic manipulations in the lab. Tech Notes provide hints that you can use on the job. Tech Alerts provide safety warnings and help you avoid common errors. Guidelines and objectives are consistent with the ASHP Model Curriculum for Technician Training. Student resources on an Evolve companion website help you review and apply what you have learned with quizzes, syringe calculations, and critical thinking exercises.
Author : H.B. Dick
Publisher : Springer Science & Business Media
ISBN 13 : 3642597793
Total Pages : 229 pages
Book Rating : 4.6/5 (425 download)
Download or read book Viscoelastics in Ophthalmic Surgery written by H.B. Dick and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: It will be difficult to find an ophthalmic surgeon who will gladly do his work entirely without viscoelastics. Within just a few years this group of substances has enlarged the field of ophthalmic surgery enormously. Many procedures have be come safer and simpler and other techniques could only be developed because of the availability of visco elastics. Especially cataract surgery and implantation of intraocular lenses have benefitted. Implantation of an intraocular lens can be per formed much more reliably into the capsular bag without endangering the posterior capsule. Implantation of foldable lenses would be almost impossible without visco elastics. However, other surgical maneuvers also necessitate visco elastics, especially when the anterior chamber must be maintained, the corneal endothelium must be protected and delicate tissues must be manipulated. A cor neal transplant can be sutured safely into the recipient corneal ring using visco elastics. Even in glaucoma surgery, visco elastics gain importance as they are being used in trabeculectomy or in deep sclerectomy with additional viscocana lostomy. But which substance is best for which purpose? Just as much as a basic phar macological knowledge is necessary for a rational use of drugs, in-depth know ledge of physicochemical properties and objective investigations are prerequi sites for a logical selection of visco elastics from an ever increasing number of available substances. H.
Author : Parag Kolhe
Publisher : Springer Science & Business Media
ISBN 13 : 1461479789
Total Pages : 590 pages
Book Rating : 4.4/5 (614 download)
Download or read book Sterile Product Development written by Parag Kolhe and published by Springer Science & Business Media. This book was released on 2013-10-12 with total page 590 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
Author : Helmut Reuter
Publisher : CRC Press
ISBN 13 : 9781566760584
Total Pages : 313 pages
Book Rating : 4.7/5 (65 download)
Download or read book Aseptic Processing of Foods written by Helmut Reuter and published by CRC Press. This book was released on 1993-10-06 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Brendan Cooper
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781545231661
Total Pages : 164 pages
Book Rating : 4.2/5 (316 download)
Download or read book Aseptic Processing for Engineers written by Brendan Cooper and published by Createspace Independent Publishing Platform. This book was released on 2017-04-07 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a short introduction to Depyrogenation, Isolators and Aseptic Filling. The information is presented in simple language in order to make the material accessible and readable. It provides a concise and compact resource for Engineers and Scientists working within Biotechnology. While there a many book titles, guidance standards and reference books, there format does not allow for logical or practical reading. This book introduces key concepts in Aseptic processing and aims to provide the reader with knowledge that can be applied in industry. Perfect for those new to Aseptic Processing and wish to gain an aptitude in Depyrogenation and Aseptic Processing. Content includes: Introduction to Depyrogenation Tunnels, Isolators and Aspetic Filling, Equipment Validation, Performance Qualification, Critical Utilities, Facilities and Container Closure. A glossary is also provided for quick reference. Page Count 170 (Paperback 6"x 9")
Author : Alison M. Beaney
Publisher :
ISBN 13 : 9780857113078
Total Pages : 0 pages
Book Rating : 4.1/5 (13 download)
Download or read book Quality Assurance of Aseptic Preparation Services written by Alison M. Beaney and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality Assurance of Aseptic Preparation Services Standards Handbook (also known as the Yellow Guide) provides standards for unlicensed aseptic preparation in the UK, as well as practical information to aid implementation of the standards. The handbook delivers essential standards in a practical way and in a format that will be useful for pharmacy management, staff working in aseptic preparation units and those whose role it is to audit the services. The accompanying support resources help with understanding the complexities of relevant topics including microbiology, radiopharmaceuticals, advanced therapy medicinal products, technical (quality) agreements and capacity planning. All the standards have been revised and updated for this 5th edition. The text is produced on behalf of the Royal Pharmaceutical Society (RPS) and the NHS Pharmaceutical Quality Assurance Committee. New in this edition: Replaces the 4th edition standards and forms the basis for an ongoing audit program in the NHS Many new and revised standards Greater emphasis on Pharmaceutical Quality Systems; the responsibilities of pharmacy management, Chief Pharmacists (or equivalent), has been expanded in line with developments in Good Manufacturing Practice Reformatted into 2 parts: standards and support resources. This is a new collaboration between the RPS and NHS. Since the previous edition the RPS has become the professional body for pharmacists and pharmaceutical scientists. RPS launched these standards as part of a library of professional standards and a programme of work to create standards for all areas of pharmacy. The Handbook is essential for pharmacists, hospital pharmacy management and technical services teams, and auditors of unlicensed NHS hospital pharmacy aseptic preparation services in the UK, pharmacists and regulators. The text is used to inform standards used in several other countries.
Author :
Publisher :
ISBN 13 :
Total Pages : 59 pages
Book Rating : 4.:/5 (466 download)
Download or read book Guidance for industry written by and published by . This book was released on 2004 with total page 59 pages. Available in PDF, EPUB and Kindle. Book excerpt:
