Advanced Aseptic Processing Technology
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Advanced Aseptic Processing Technology
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Author : James Agalloco
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Advanced Aseptic Processing Technology written by James Agalloco 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.
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
Validation Of Pharmaceutical Processes
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Author : James P. Agalloco
language : en
Publisher: CRC Press
Release Date : 2007-09-25
Validation Of Pharmaceutical Processes written by James P. Agalloco and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-09-25 with Medical categories.
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Practical Aseptic Processing
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Author : Jack Lysfjord
language : en
Publisher: Parenteral Drug Association
Release Date : 2009
Practical Aseptic Processing written by Jack Lysfjord and has been published by Parenteral Drug Association this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009 with Drugs categories.
Handbook Of Validation In Pharmaceutical Processes Fourth Edition
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Author : James Agalloco
language : en
Publisher: CRC Press
Release Date : 2021-10-28
Handbook Of Validation In Pharmaceutical Processes Fourth Edition written by James Agalloco and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-28 with Medical categories.
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
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
Aseptic Pharmaceutical Manufacturing Ii
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Author : Michael J. Groves
language : en
Publisher: CRC Press
Release Date : 2020-08-26
Aseptic Pharmaceutical Manufacturing Ii written by Michael J. Groves and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-08-26 with Business & Economics categories.
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.
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.
Handbook Of Aseptic Processing And Packaging
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Author : Jairus R. D. David
language : en
Publisher: CRC Press
Release Date : 2012-11-15
Handbook Of Aseptic Processing And Packaging written by Jairus R. D. David and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-11-15 with Technology & Engineering categories.
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
Extracellular Matrix Derived Implants In Clinical Medicine
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Author : Daniel L Mooradian
language : en
Publisher: Woodhead Publishing
Release Date : 2016-05-18
Extracellular Matrix Derived Implants In Clinical Medicine written by Daniel L Mooradian and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-05-18 with Technology & Engineering categories.
Extracellular Matrix-Derived Implants in Clinical Medicine comprehensively covers the emergence of tissue engineering and regenerative medicine over the past few decades, along with discussions of continuous funding and research. The book provides a state-of-the-art review of this increasingly important technology and how it is translating from bench to bedside. Part One of the book looks at the historical use of human and animal tissues, focusing on the main application areas, including cardiovascular, hard and soft tissue engineering, and neurological, while Part Two examines the challenges in harvesting, processing, and manufacturing of extracellular matrices, with a final section reviewing the international regulatory environment and economics of tissue-based products. - Addresses issues of tissue engineering and regenerative medicine from a biomaterials industry perspective - Looks at the historical use of human and animal tissues, focusing on the main application areas, including cardiovascular, hard and soft tissue engineering, and neurological - Examines the challenges in harvesting, processing, and manufacturing of extracellular matrices - Reviews the international regulatory environment and economics of tissue-based products
Pharmaceutical Dosage Forms Parenteral Medications
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Author : Sandeep Nema
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Pharmaceutical Dosage Forms Parenteral Medications written by Sandeep Nema 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.
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the