How To Design And Implement Powder To Tablet Continuous Manufacturing Systems
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How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems
How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing. - Discusses the development of strategy blueprints in the design of continuous processes - Shows how to create process flowsheet models from individual unit operation models - Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases - Covers the evolving regulatory expectations for continuous manufacturing - Provides readers with ways to more effectively navigate these expectations
How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems
How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing. Discusses the development of strategy blueprints in the design of continuous processes Shows how to create process flowsheet models from individual unit operation models Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases Covers the evolving regulatory expectations for continuous manufacturing Provides readers with ways to more effectively navigate these expectations
Sustainable Pharmaceutical Product Development and Optimization Processes
This book offers unparalleled insight into the convergence of sustainability and pharmaceutical product development, with a specific focus on optimization processes. By addressing the urgent demand for more environmentally conscious and efficient strategies in the drug development industry, particularly in an era where the world faces the mounting challenges posed by climate change, the book provides a comprehensive guide for integrating sustainability principles throughout the pharmaceutical product lifecycle, directly contributing to the United Nations Sustainable Development Goals (SDGs), such as SDG 12 (Responsible Consumption and Production) and SDG 13 (Climate Action). The chapters cover key topics, including the application of green chemistry, eco-design principles, sustainable sourcing of raw materials, waste reduction strategies, and the use of renewable energy in pharmaceutical manufacturing processes. Throughout the book, case studies are integrated, offering practical insights and concurrently highlighting the economic and environmental advantages of sustainable practices, thereby addressing skepticism regarding the feasibility and profitability of such initiatives. The book also discusses regulatory considerations, ethical implications, and the challenges and opportunities associated with moving toward more sustainable practices in pharmaceutical development. Importantly, this book seeks to solve the problem of the knowledge gap and lack of practical resources for professionals in the pharmaceutical industry who aspire to implement sustainable and optimized processes. This work consolidates a network of professionals and scholars keenly focused on future sustainability challenges, developing enhancement methodologies, and sharing successful strategies for implementing eco-friendly practices in pharmaceutical sectors worldwide, ultimately contributing to the global effort to achieve the SDGs by 2030. With a focus on pharmaceutical professionals, researchers, academicians, and students, the book serves as a valuable reference for those involved in drug development and process optimization. Policymakers and regulatory bodies might also find it insightful, as it addresses current landscapes, challenges, and future directions in sustainable pharmaceutical product development.