Sterile Product Development
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Sterile Product Development
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Author : Parag Kolhe
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-10-12
Sterile Product Development written by Parag Kolhe and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-12 with Medical categories.
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.
Sterile Drug Products
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Author : Michael J. Akers
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Sterile Drug Products written by Michael J. Akers and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
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
Sterile Product Facility Design And Project Management
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Author : Jeffrey N. Odum
language : en
Publisher: CRC Press
Release Date : 2004-03-29
Sterile Product Facility Design And Project Management written by Jeffrey N. Odum and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-03-29 with Medical categories.
Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provid
Sterile Product Facility Design And Project Management Second Edition
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Author : Jeffrey N. Odum
language : en
Publisher: CRC Press
Release Date : 2004-03-29
Sterile Product Facility Design And Project Management Second Edition written by Jeffrey N. Odum and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-03-29 with Medical categories.
Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.
Sterile Product Design Preparation
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Author : Laura Thoma
language : en
Publisher:
Release Date : 2003
Sterile Product Design Preparation written by Laura Thoma and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with categories.
Sterile Product Design, Preparation and Management is the fifth module in the Home Infusion Pharmacy Program. The entire program comprises seven self-study modules. Learners will earn CE as each individual module is completed and the Home Infusion Pharmacy Certificate will be awarded once all seven modules are completed.
Sterile Pharmaceutical Products
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Author : KennethE. Avis
language : en
Publisher: Routledge
Release Date : 2018-03-29
Sterile Pharmaceutical Products written by KennethE. Avis and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-29 with Medical categories.
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.
Quality By Design For Biopharmaceutical Drug Product Development
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Author : Feroz Jameel
language : en
Publisher: Springer
Release Date : 2015-04-01
Quality By Design For Biopharmaceutical Drug Product Development written by Feroz Jameel and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-01 with Medical categories.
This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
Assurance Of Sterility For Sensitive Combination Products And Materials
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Author : Byron Lambert
language : en
Publisher: Academic Press
Release Date : 2019-06-15
Assurance Of Sterility For Sensitive Combination Products And Materials written by Byron Lambert and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-15 with Technology & Engineering categories.
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. Introduces sterilization principles at the material selection and design stages Addresses the industry need for new sterilization processes for new medical devices and biomaterials Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies
Sterile Processing Of Pharmaceutical Products
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Author : Sam A. Hout
language : en
Publisher: John Wiley & Sons
Release Date : 2022-01-26
Sterile Processing Of Pharmaceutical Products written by Sam A. Hout and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-26 with Technology & Engineering categories.
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.
Handbook Of Pharmaceutical Manufacturing Formulations
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Author : Safaraz K. Niazi
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Handbook Of Pharmaceutical Manufacturing Formulations written by Safaraz K. Niazi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster