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Author: David Ganderton
Publisher: Elsevier
ISBN: 1483141748
Category : Medical
Languages : en
Pages : 259
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Book Description
Pharmaceutical Monographs, Volume 7: Unit Processes in Pharmacy provides a survey of the industrial processes used in the large-scale preparation of pharmaceuticals. This book examines the movement of fluids, the transfer of heat, mass transfer, and the properties of powers. Organized into two parts encompassing 14 chapters, this book begins with an overview of the analysis of the flow of fluids through a permeable bed of solids that is widely applied in filtration, leaching, and several other processes. This text then examines the transfer of heat from one fluid to another across a solid boundary. Other chapters consider the movement of relatively large units of gas, called eddies, from one region to another that causes mixing of the components of the gas. This book discusses as well the principle of filtration. The final chapter deals with the scale of segregation and the intensity of segregation. This book is a valuable resource for undergraduate students of pharmacy and allied subjects.
Author: David Ganderton
Publisher: Elsevier
ISBN: 1483141748
Category : Medical
Languages : en
Pages : 259
Get Book Here
Book Description
Pharmaceutical Monographs, Volume 7: Unit Processes in Pharmacy provides a survey of the industrial processes used in the large-scale preparation of pharmaceuticals. This book examines the movement of fluids, the transfer of heat, mass transfer, and the properties of powers. Organized into two parts encompassing 14 chapters, this book begins with an overview of the analysis of the flow of fluids through a permeable bed of solids that is widely applied in filtration, leaching, and several other processes. This text then examines the transfer of heat from one fluid to another across a solid boundary. Other chapters consider the movement of relatively large units of gas, called eddies, from one region to another that causes mixing of the components of the gas. This book discusses as well the principle of filtration. The final chapter deals with the scale of segregation and the intensity of segregation. This book is a valuable resource for undergraduate students of pharmacy and allied subjects.
Author: Preetanshu Pandey
Publisher: Woodhead Publishing
ISBN: 0081001800
Category : Medical
Languages : en
Pages : 465
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Book Description
The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. - Explains the commonly used modeling and simulation tools - Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing - Practical examples of the application of modeling tools through case studies - Discussion of modeling techniques used for a risk-based approach to regulatory filings - Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points
Author: Kenneth E. Avis
Publisher: CRC Press
ISBN: 9781574910827
Category : Medical
Languages : en
Pages : 368
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Book Description
This book is a complete, authoritative resource on the coating of tablets, capsules, and other solid dosage forms of therapeutic agents. Fourteen authors cover the industry's technologies. The book begins with a full discussion of the primary processes -- sugar coating, film coating, and microencapsulation -- as well as the rationale for coating, methodologies, formulations, processing methods, and equipment and cleaning. Then it explores automation of the coating process, including hardware and software requirements. Finally, the book examines major stability and quality control issues. Regulations underlie all discussions.
Author: Nozari, Hamed
Publisher: IGI Global
ISBN: 1522559221
Category : Business & Economics
Languages : en
Pages : 399
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Book Description
In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy.
Author: Peter Kleinebudde
Publisher: John Wiley & Sons
ISBN: 1119001323
Category : Science
Languages : en
Pages : 645
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Book Description
A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259809
Category : Science
Languages : en
Pages : 1386
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Book Description
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Author: Bhavishya Mittal
Publisher: Academic Press
ISBN: 0128047321
Category : Medical
Languages : en
Pages : 192
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Book Description
How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. - Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more - Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin - Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309487811
Category : Medical
Languages : en
Pages : 69
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Book Description
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Author: Kate McCormick
Publisher: Routledge
ISBN: 1317081404
Category : Business & Economics
Languages : en
Pages : 289
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Book Description
A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.
Author: Krist V. Gernaey
Publisher: MDPI
ISBN: 303928424X
Category : Technology & Engineering
Languages : en
Pages : 188
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Book Description
The Special Issue on “Model-Based Tools for Pharmaceutical Manufacturing Processes” will curate novel advances in the development and application of model-based tools to address ever-present challenges of the traditional pharmaceutical manufacturing practice as well as new trends. This book provides a collection of nine papers on original advances in the model-based process unit, system-level, quality-by-design under uncertainty, and decision-making applications of pharmaceutical manufacturing processes.
