Download or read book Water Activity in Foods written by Gustavo V. Barbosa-Cánovas and published by John Wiley & Sons. This book was released on 2020-05-12 with total page 636 pages. Available in PDF, EPUB and Kindle. Book excerpt: This second edition of Water Activity in Foods furnishes those working within food manufacturing, quality control, and safety with a newly revised guide to water activity and its role in the preservation and processing of food items. With clear, instructional prose and illustrations, the book’s international team of contributors break down the essential principles of water activity and water–food interactions, delineating water’s crucial impact upon attributes such as flavor, appearance, texture, and shelf life. The updated and expanded second edition continues to offer an authoritative overview of the subject, while also broadening its scope to include six newly written chapters covering the latest developments in water activity research. Exploring topics ranging from deliquescence to crispness, these insightful new inclusions complement existing content that has been refreshed and reconfigured to support the food industry of today.
Download or read book Water activity applications in the pharmaceutical industry written by Anthony J. Fontana and published by . This book was released on 2009 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Water Activity in Foods written by Gustavo V. Barbosa-Cánovas and published by John Wiley & Sons. This book was released on 2020-05-14 with total page 864 pages. Available in PDF, EPUB and Kindle. Book excerpt: This second edition of Water Activity in Foods furnishes those working within food manufacturing, quality control, and safety with a newly revised guide to water activity and its role in the preservation and processing of food items. With clear, instructional prose and illustrations, the book’s international team of contributors break down the essential principles of water activity and water–food interactions, delineating water’s crucial impact upon attributes such as flavor, appearance, texture, and shelf life. The updated and expanded second edition continues to offer an authoritative overview of the subject, while also broadening its scope to include six newly written chapters covering the latest developments in water activity research. Exploring topics ranging from deliquescence to crispness, these insightful new inclusions complement existing content that has been refreshed and reconfigured to support the food industry of today.
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 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
Download or read book Physicochemical Principles of Pharmacy written by Alexander T Florence and published by Pharmaceutical Press. This book was released on 2015-12-01 with total page 665 pages. Available in PDF, EPUB and Kindle. Book excerpt: This 6th edition of the established textbook covers every aspect of drug properties from the design of dosage forms to their delivery by all routes to sites of action in the body.
Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-09-29 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Download or read book Emergence of Pharmaceutical Industry Growth with Industrial IoT Approach written by Valentina Emilia Balas and published by Academic Press. This book was released on 2019-09-24 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: Emergence of Pharmaceutical Industry Growth with Industrial IoT Approach uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches, create efficiencies and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Pharmaceutical manufacturing companies are no exception to this, as IoT has the potential to revolutionize aspects of the pharmaceutical manufacturing process, from drug discovery to manufacturing. Using clear, concise language and real world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety of topics presented offers readers multiple perspectives on a how to integrate the Internet of Things into pharmaceutical manufacturing. - Covers efficiency improvements of pharmaceutical manufacturing through IoT/Big Data approaches - Explores cutting-edge technologies through sensor enabled environment in the pharmaceutical industry - Discusses the systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing
Download or read book Accelerated Predictive Stability APS written by Fenghe Qiu and published by Academic Press. This book was released on 2018-05-14 with total page 514 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product's stability and predict drug expiry more accurately and quickly. - Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS) - Presents the scientific basis of different APS models - Includes the applications and utilities of APS that are demonstrated through numerous case studies - Covers up-to-date regulatory experience
Download or read book Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry written by Carrillo-Cedillo, Eugenia Gabriela and published by IGI Global. This book was released on 2022-03-18 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality control in pharmaceutical products and medical devices is vital for users as failing to comply with national and international regulations can lead to accidents that could easily be avoided. For this reason, manufacturing a quality medical product will support patient safety. Microbiologists working in both the pharmaceutical and medical device industries face considerable challenges in keeping abreast of the myriad microbiological references available to them and the continuously evolving regulatory requirements. Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry presents the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards to not cause problems to the health of patients. It reinforces and updates the knowledge of analytical, instrumental, and biological methods to demonstrate the correct quality control and good manufacturing practice for pharmaceutical products and medical devices. Covering topics such as pharmaceutical nano systems, machine learning, and software validation, this book is an essential resource for managers, engineers, supervisors, pharmacists, chemists, academicians, and researchers.
Download or read book Pharmaceuticals and Personal Care Products Waste Management and Treatment Technology written by Majeti Narasimha Vara Prasad and published by Butterworth-Heinemann. This book was released on 2019-04-04 with total page 507 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals and Personal Care Products Waste Management and Treatment Technology: Emerging Contaminants and Micro Pollutants provides the tools and techniques for identifying these contaminates and applying the most effective technology for their remediation, recovery and treatment. The consumption of pharmaceuticals and personal care products (PPCPs) has grown significantly over the last 35 years, thus increasing their potential risk to the environment. As PPCPs are very difficult to detect and remove using conventional wastewater treatment methods, this book provides solutions to a growing problem. - Includes sampling, analytical and characterization methods and technology for detecting PPCPs in the environment - Provides advanced treatment and disposal technologies for the removal of PPCPs from wastewater, surface water, landfills and septic systems - Examines the pathways of PPCPs into the environment
Download or read book Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry written by Eugenia Gabriela Carrillo-Cedillo and published by . This book was released on 2022 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: "This book gives the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations highlighting the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards so as not to cause problems to the health of patients"--
Download or read book Drying Technologies for Biotechnology and Pharmaceutical Applications written by Satoshi Ohtake and published by John Wiley & Sons. This book was released on 2020-02-10 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.
Download or read book Water Stress in Biological Chemical Pharmaceutical and Food Systems written by Gustavo F. Gutiérrez-López and published by Springer. This book was released on 2015-07-23 with total page 666 pages. Available in PDF, EPUB and Kindle. Book excerpt: Water Stress Management contains the invited lectures and selected oral and poster presentations of the 11th International Symposium on the Properties of Water (ISOPOW), which was held in Queretaro, Mexico 5-9 September 2010. The text provides a holistic description and discussion of state-of-the-art topics on the role of water in Biological, Chemical, Pharmaceutical and Food systems within a frame of an integrated approach and future trends on the subject. Different points-of-view about the state of water and phase transitions in a variety of substrates are presented. ISOPOW is a non-profit scientific organization whose activities aim at progressing the understanding of the properties of water in food and related biological systems and the exploitation of this understanding in improved raw materials, products and processes in the food, agro food or related industries. The first Symposium was organized in Glasgow, Scotland in 1974. Since then, ISOPOW meetings have promoted the exchange of knowledge between scientists involved in the study of food materials and scientists interested in water from a more basic point of view and the dialogue between academic and industrial scientists/technologists.
Download or read book Development and Validation of Analytical Methods written by Christopher M. Riley and published by Elsevier. This book was released on 1996-05-29 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
Download or read book Moisture Sorption written by Leonard N. Bell and published by . This book was released on 2000 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This manual explains water activity in foods and shows why commonly held ideas about free and bound water are often inaccurate. It demonstrates how moisture sorption isotherms are created and how they are used to solve real-world problems such as the change in rate of moisture gain for individual packaged products over time, or the amount of sugar needed to lower the water activity of a product to make it shelf stable.The authors emphasize the physical chemistry of water in biological systems. For every equation provided they furnish examples from practical experience. These examples will help food scientists understand thermodynamics (equilibrium processes and water activity), dynamics (rate processes such as mass transfer of moisture between ingredients), and structure (weeping, swelling, droplets, and edible barriers). Using this manual will help solve product development problems and improve the quality of the foods brought to the market.
Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-09 with total page 690 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
Download or read book Pharmaceutical Industry Practices on Genotoxic Impurities written by Heewon Lee and published by CRC Press. This book was released on 2014-08-29 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text: Explores the safety, quality, and regulatory aspects of GTIs Provides an overview of the latest FDA and EMEA guidelines Explains the how and why of various GTI control tactics and practices Describes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testing Includes real-life examples of GTI control in drug substance and drug product development processes Containing case studies from large and small pharmaceutical firms in multiple geographical regions, Pharmaceutical Industry Practices on Genotoxic Impurities supplies an overview of—and a current framework for—GTI control in the pharmaceutical industry, demonstrating how proper management of GTIs can occur with the appropriate guidance, a firm grasp of the practical implications, and effective information sharing between disciplines.
