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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 : 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 : 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 : 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 : Yvonne Bouwman-Boer
Publisher : Springer
ISBN 13 : 3319158147
Total Pages : 873 pages
Book Rating : 4.3/5 (191 download)
Download or read book Practical Pharmaceutics written by Yvonne Bouwman-Boer and published by Springer. This book was released on 2015-08-24 with total page 873 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 : 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 : 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 : Destin A. LeBlanc
Publisher : CRC Press
ISBN 13 : 1000835596
Total Pages : 216 pages
Book Rating : 4.0/5 (8 download)
Download or read book Cleaning Validation written by Destin A. LeBlanc and published by CRC Press. This book was released on 2022-12-23 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this volume will help in designing a more effective and efficient cleaning validation program. Features • Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. • The author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. • Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. • Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. • A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.
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 : Byron J. Lambert
Publisher : Academic Press
ISBN 13 : 0128050829
Total Pages : 266 pages
Book Rating : 4.1/5 (28 download)
Download or read book Assurance of Sterility for Sensitive Combination Products and Materials written by Byron J. Lambert and published by Academic Press. This book was released on 2019-11-30 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient's best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design.
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 : Kenneth E. Avis
Publisher : CRC Press
ISBN 13 : 9780935184815
Total Pages : 432 pages
Book Rating : 4.1/5 (848 download)
Download or read book Sterile Pharmaceutical Products written by Kenneth E. Avis and published by CRC Press. This book was released on 1995-10-31 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterile Pharmaceutical Products: Process Engineering Applications addresses the key concepts and applications of the sterile pharmaceutical manufacturing industry. It covers elements of the design, installation, validation, and usage of critical processes associated with sterile product manufacture. From water systems to clean-in-place systems, to sterile powder handling and robotic applications in sterile production environments, this book addresses the issues of system implementation, integration, and operations. Written by recognized experts and peer reviewed for accuracy, all chapters include references to supplemental resources and numerous illustrations.
Author : E. Clyde Buchanan
Publisher : ASHP
ISBN 13 : 1585283312
Total Pages : 497 pages
Book Rating : 4.5/5 (852 download)
Download or read book Compounding Sterile Preparations written by E. Clyde Buchanan and published by ASHP. This book was released on 2009-02-01 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP . Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive documentation for the guidelines is included in the appendices.Chapters new to this edition focus on: Gap analysis and action plans Safe use of automatic compounding devices Cleaning and disinfecting Radiopharmaceuticals as CSPs Allergen extracts as CSPs.
Author : Nancy L. Moureau
Publisher : Springer
ISBN 13 : 3030031497
Total Pages : 303 pages
Book Rating : 4.0/5 (3 download)
Download or read book Vessel Health and Preservation: The Right Approach for Vascular Access written by Nancy L. Moureau and published by Springer. This book was released on 2019-06-10 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Open access book offers updated and revised information on vessel health and preservation (VHP), a model concept first published in poster form in 2008 and in JVA in 2012, which has received a great deal of attention, especially in the US, UK and Australia. The book presents a model and a new way of thinking applied to vascular access and administration of intravenous treatment, and shows how establishing and maintaining a route of access to the bloodstream is essential for patients in acute care today. Until now, little thought has been given to an intentional process to guide selection, insertion and management of vascular access devices (VADs) and by default actions are based on crisis management when a quickly selected VAD fails. The book details how VHP establishes a framework or pathway model for each step of the patient experience, intentionally guiding, improving and eliminating risk when possible. The evidence points to the fact that reducing fragmentation, establishing a pathway, and teaching the process to all stakeholders reduces complications with intravenous therapy, improves efficiency and diminishes cost. As such this book appeals to bedside nurses, physicians and other health professionals.
Author : Vesper
Publisher : David Horwood International Pub Limited
ISBN 13 : 9781930114173
Total Pages : 224 pages
Book Rating : 4.1/5 (141 download)
Download or read book GMP in Practice written by Vesper and published by David Horwood International Pub Limited. This book was released on 2000-07 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : David Roesti
Publisher : John Wiley & Sons
ISBN 13 : 1119356075
Total Pages : 594 pages
Book Rating : 4.1/5 (193 download)
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
