Author: Maik W. Jornitz
Publisher: CRC Press
ISBN: 1000083233
Category : Medical
Languages : en
Pages : 648
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Book Description
This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals. Addresses the complexities of globalizing redundancy in filtration!
Author: Maik W. Jornitz
Publisher: CRC Press
ISBN: 1420030094
Category : Business & Economics
Languages : en
Pages : 640
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Book Description
This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals. Addresses the complexities of globalizing redundancy in filtration!
Author: Maik W. Jornitz
Publisher: Springer
ISBN: 3540330186
Category : Science
Languages : en
Pages : 211
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Book Description
Author: KennethE. Avis
Publisher: Routledge
ISBN: 1351413864
Category : Medical
Languages : en
Pages : 286
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Book Description
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: Anil K. Pabby
Publisher: CRC Press
ISBN: 0849395496
Category : Science
Languages : en
Pages : 1210
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Book Description
The Handbook of Membrane Separations: Chemical, Pharmaceutical, and Biotechnological Applications provides detailed information on membrane separation technologies as they have evolved over the past decades. To provide a basic understanding of membrane technology, this book documents the developments dealing with these technologies. It explores chemical, pharmaceutical, food processing and biotechnological applications of membrane processes ranging from selective separation to solvent and material recovery. This text also presents in-depth knowledge of membrane separation mechanisms, transport models, membrane permeability computations, membrane types and modules, as well as membrane reactors.
Author: Maik J. Jornitz
Publisher: CRC Press
ISBN: 0849379547
Category : Medical
Languages : en
Pages : 816
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Book Description
Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, in
Author: Michael J. Akers
Publisher: CRC Press
ISBN: 1420020560
Category : Medical
Languages : en
Pages : 516
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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 book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.
Author: K. Scott
Publisher: Elsevier
ISBN: 9780080532899
Category : Technology & Engineering
Languages : en
Pages : 904
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Book Description
This manual contains necessary and useful information and data in an easily accessible format relating to the use of membranes. Membranes are among the most important engineering components in use today, and each year more and more effective uses for membrane technologies are found - for example: water purification, industrial effluent treatment, solvent dehydration by per-vaporation, recovery of volatile organic compounds, protein recovery, bioseparations and many others. The pace of change in the membrane industry has been accelerating rapidly in recent years, occasioned in part by the demand of end-users, but also as a result of the investment in R&D by manufacturers. To reflect these changes the author has obtained the latest information from some of the leading suppliers in the business. In one complete volume this unique handbook gives practical guidance to using selected membrane processes in individual industries while also providing a useful guide to equipment selection and usage.
Author: Parag Kolhe
Publisher: Springer Science & Business Media
ISBN: 1461479789
Category : Medical
Languages : en
Pages : 585
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Book Description
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: Sam A. Hout
Publisher: CRC Press
ISBN: 1000406121
Category : Technology & Engineering
Languages : en
Pages : 148
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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.
