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Author: Maik W. Jornitz
Publisher: CRC Press
Published: 2020-04-15
Total Pages: 648
ISBN-13: 1000083233
DOWNLOAD EBOOKThis 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
Published: 2020-04-15
Total Pages: 640
ISBN-13: 1420030094
DOWNLOAD EBOOKThis 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
Published: 2006-01-14
Total Pages: 211
ISBN-13: 3540330186
DOWNLOAD EBOOKAuthor: KennethE. Avis
Publisher: Routledge
Published: 2018-03-29
Total Pages: 428
ISBN-13: 1351413872
DOWNLOAD EBOOKSterile 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
Published: 2008-07-07
Total Pages: 1210
ISBN-13: 0849395496
DOWNLOAD EBOOKThe 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
Published: 2007-11-28
Total Pages: 816
ISBN-13: 0849379547
DOWNLOAD EBOOKFiltration 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
Published: 2016-04-19
Total Pages: 517
ISBN-13: 1420020560
DOWNLOAD EBOOKSterile 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
Published: 2021-07-04
Total Pages: 148
ISBN-13: 1000406121
DOWNLOAD EBOOKThis 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: Parag Kolhe
Publisher: Springer Science & Business Media
Published: 2013-10-12
Total Pages: 590
ISBN-13: 1461479789
DOWNLOAD EBOOKThis 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: Christian E. Butzke
Publisher: Elsevier
Published: 2010-07-19
Total Pages: 425
ISBN-13: 0857090186
DOWNLOAD EBOOKWhat is the best way to cold settle my white juices? How do I sample for Brettanomyces? What’s the best procedure to clean or store a used barrel? How do I care for the winery pump? My wine is too astringent - what do I do? When can I skip filtering my wine? When will it re-ferment and push the corks? How do I best store and ship my bottled wine?Expert answers to these and further questions that arise during winemaking can be found in this convenient reference book. Arranged in practical question and answer format, Winemaking problems solved provides brief, quickly accessible solutions to more than one hundred issues of frequent concern to winemaking professionals.Chapters review issues associated with grape analysis, juice and must preparation, yeast and malolactic fermentation, wine clarification and stabilisation, filtration, packaging and storage. Sections on winery equipment maintenance and troubleshooting, wine microbiology and sanitation are also included. The final part of the book focuses on particular wine quality issues, such as hazes and off-odours.With expert contributions from a diverse team of international enologists, Winemaking problems solved is an essential, hands-on reference for professionals in the winemaking industry and students of enology. Provides solutions to a variety of issues of frequent concern to wine making professionals Reviews issues related to grape analysis, filtration, packaging and microbiology A hands-on reference book written by a diverse team of international enologists
