Advances In Sterile Manufacturing And Aseptic Processing
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Advances In Sterile Manufacturing And Aseptic Processing
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Author :
language : en
Publisher:
Release Date : 2008
Advances In Sterile Manufacturing And Aseptic Processing written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with categories.
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
Aseptic Pharmaceutical Manufacturing Ii
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Author : Michael J. Groves
language : en
Publisher: CRC Press
Release Date : 1995-05-31
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 1995-05-31 with Medical 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.
Aseptic Pharmaceutical Manufacturing
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Author : Michael J Groves
language : en
Publisher: CRC Press
Release Date : 2019-08-30
Aseptic Pharmaceutical Manufacturing 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 2019-08-30 with 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.
Aseptic Pharmaceutical Manufacturing
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Author : Wayne P. Olson
language : en
Publisher: Interpharm Press Incorporated
Release Date : 1987
Aseptic Pharmaceutical Manufacturing written by Wayne P. Olson and has been published by Interpharm Press Incorporated this book supported file pdf, txt, epub, kindle and other format this book has been release on 1987 with Medical categories.
Containment Technology
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Author : Hans-Jürgen Bässler
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-10-01
Containment Technology written by Hans-Jürgen Bässler 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 2013-10-01 with Science categories.
This book covers all aspects of containment technology in depth and the latest developments in this exciting field are introduced. This book is a key publication to planning engineers, production managers and those interested in getting a picture of the different applications of the isolator technology. References on literature, laws, norms and guidelines will support the reader to become acquainted with the containment technology.
Aseptic Processing And Packaging Of Particulate Foods
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Author : E.M. Willhoft
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Aseptic Processing And Packaging Of Particulate Foods written by E.M. Willhoft 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 2012-12-06 with Technology & Engineering categories.
Publications in food technology proliferate; however, noticeable by its absence of coverage is the subject of processing and packaging of particulates in foods. Recent years have seen significant advances which will almost certainly result in substitution of existing and conventional retorting. In addition, when com bined with high temperature/short time (HTST) processing, we can expect substantial further growth, reflecting quality and convenience advantages over products processed from yesterday's technologies. The anticipated growth in particulates is driven by both materials and packaging advances and only requires modest marketing of the organoleptic advantages to establish their place on menu options. The directions taken in packaging developments, especially those interfacing with the latest and established methods of processing, are increasingly influ enced by the need to design packaging on a cradle-to-grave basis. Time was when multi-laminated films on board satisfied the total needs of consumers of aseptic products. The problems of recycling combustible, i.e. energy generating mate rials laminated with aluminium foil, are becoming sensitive issues in a world preoccupied with recycling, and are creating openings for alternative and envi ronmentally friendly material combinations. This book brings together advanced technologies in the field, to provide information for professionals with interests in aseptic processing on how to go about selecting a system appropriate to their commercial needs and constraints.
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
Advances In Aseptic Processing Technologies
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Author : Rakesh K. Singh
language : en
Publisher: Elsevier Science & Technology
Release Date : 1992-01-01
Advances In Aseptic Processing Technologies written by Rakesh K. Singh and has been published by Elsevier Science & Technology this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992-01-01 with Technology & Engineering categories.
A three year research program on advancing the use of aseptic processing and packaging of foods has recently been completed. The Nordic project "Aseptic Processes" has involved 8 laboratories and has had a budget of more than 2 million US dollars. A group of 34 industry sponsors has participated actively in the project. The project objective has been to develop knowledge as well as measuring methods for ensuring the safety and quality of complex, high viscosity foods with special emphasis on particle containing foods. The projetc has been divided into three subprojetcs; methods for microbiological control of aseptic products and systems, methods for controlling the processing of particles e.g. RTD, TTD and mechanical integrity and methods for testing ...the integrity of aseptic packages. These methods will be discussed and their use exemplified. The project has also included a program for extensive information and knowledge transfer.
