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Author: James Agalloco
Publisher: CRC Press
ISBN: 1439825440
Category : Medical
Languages : en
Pages : 495
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Book Description
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
Author: James Agalloco
Publisher: CRC Press
ISBN: 1439825440
Category : Medical
Languages : en
Pages : 495
Get Book Here
Book Description
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
Author: Jack Lysfjord
Publisher: Parenteral Drug Association
ISBN: 9781933722283
Category : Drugs
Languages : en
Pages : 405
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Book Description
Author: Jairus R. D. David
Publisher: CRC Press
ISBN: 1439807205
Category : Technology & Engineering
Languages : en
Pages : 389
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Book Description
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
Author: Michael J. Akers
Publisher: CRC Press
ISBN: 1420020560
Category : Medical
Languages : en
Pages : 517
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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
Author: E.M. Willhoft
Publisher: Springer
ISBN: 0751400106
Category : Technology & Engineering
Languages : en
Pages : 192
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Book Description
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.
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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Book Description
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Author: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062
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Book Description
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
Author: Parag Kolhe
Publisher: Springer Science & Business Media
ISBN: 1461479789
Category : Medical
Languages : en
Pages : 590
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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: James P. Agalloco
Publisher: CRC Press
ISBN: 1420019791
Category : Medical
Languages : en
Pages : 762
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Book Description
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
Author: Suvendu Bhattacharya
Publisher: John Wiley & Sons
ISBN: 111840632X
Category : Technology & Engineering
Languages : en
Pages : 754
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Book Description
Food processing technologies are an essential link in the food chain. These technologies are many and varied, changing in popularity with changing consumption patterns and product popularity. Newer process technologies are also being evolved to provide the added advantages. Conventional and Advanced Food Processing Technologies fuses the practical (application, machinery), theoretical (model, equation) and cutting-edge (recent trends), making it ideal for industrial, academic and reference use. It consists of two sections, one covering conventional or well-established existing processes and the other covering emerging or novel process technologies that are expected to be employed in the near future for the processing of foods in the commercial sector. All are examined in great detail, considering their current and future applications with added examples and the very latest data. Conventional and Advanced Food Processing Technologies is a comprehensive treatment of the current state of knowledge on food processing technology. In its extensive coverage, and the selection of reputed research scientists who have contributed to each topic, this book will be a definitive text in this field for students, food professionals and researchers.
