Robust Process Development

The book introduces the reader to the concepts of Scientific Molding and Scientific Processing for Injection Molding, geared towards developing a robust, repeatable, and reproducible (3Rs) molding process. The effects of polymer morphology, thermal transitions, drying, and rheology on the injection molding process are explained in detail. The development of a robust molding process is broken down into two sections and is described as the Cosmetic Process and the Dimensional Process. Scientific molding procedures to establish a 3R process are provided. The concept of Design of Experiments (DOEs) for and in injection molding is explained, providing an insight into the cosmetic and dimensional process windows. A plan to release qualified molds into production with troubleshooting tips is also provided. Topics that impact a robust process such as the use of regrind, mold cooling, and venting are also described. Readers will be able to utilize the knowledge gained from the book in their day-to-day operations immediately. The second edition includes a completely new chapter on Quality Concepts, as well as much additional material throughout the book, covering fountain flow, factors affecting post mold shrinkage, and factor selections for DOEs. There are also further explanations on several topics, such as in-mold rheology curves, cavity imbalances, intensification ratios, gate seal studies, holding time optimization of hot runner molds, valve gated molds, and parts with large gates. A troubleshooting guide for common molded defects is also provided. With the purchase of this book, you also receive a free personal access code to download the eBook.

The approaches to design process plants described in this book lead to process designs which require 30-40% less capital than usual. The book is unique since it is the first comprehensive work addressing both the total process design and operational approach. Technological developments during the last decade made the design of really competitive processes possible. Mechanical developments have resulted in reliable and robust equipment. Process developments have created opportunities to minimize the amount of equipment; furthermore, different logistic approaches, integration of process functionality and intensification of the unit operations are possible. Computer and control technology allows remote-control operation and first pass prime production. In this work design philosophies are discussed and their implementation is shown as a structured approach for planned and existing plants. Numerous examples are presented to illustrate what simple design can create. The work is intended for experienced engineers and managers involved in process design, control design and operation, but is also interesting for students. Project engineers and managers have to apply these new approaches to achieve competitive processes. "A process plant should meet the simplicity and robustness of a household refrigerator." This book has been written to allow to achieve this aim. "Chairman of the Judges Award" from IChemE 2003

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

Powerful and elegantly simple. Achieve higher quality...lower costs...faster time to market Companies worldwide have used the methods of quality expert Genichi Taguchi for the past 30 years with phenomenal product development cost savings and quality improvements. Robust Engineering, by this three-time Deming Prize winner, along with Subir Chowdhury and Shin Taguchi, is the first book to explain and illustrate his newest, most revolutionary methodology, Technology Development. It joins Design of Experiments and Robust Design as the framework on which your company can build a competitive edge. Case studies of real-world organizations Ford, ITT, 3M, Minolta, NASA, Nissan, Xerox and 9 others show you how the techniques of all three methodologies can be successfully applied. You'll hammer flexibility into your manufacturing organization to minimize product development costs, reduce product time-to-market, and fully satisfy customers needs. Project Management is going to be huge in the next decade...--Fortune Busy managers single-source guide to planning, organizing and controlling projects At last there's a concise, compact (5Ó x 8Ó) hands-on guide that puts state-of-the-art management concepts and processes at your fingertips. Project Manager's Portable Handbook, by David I. Cleland and Lewis R. Ireland, is your step-by-step guide to the nuts-and-bolts details that spell project management success. YouÕre shown how to organize and manage everything from small to multiple projects...lead and coach project team members...and manage within a strategic context from project partnering to dealing with the board of directors and other stakeholders. You'll find out how to: Select and use PM software; Develop winning proposals; Handle legal considerations; Come out on top in contract

A practical overview of a full rangeof approaches to discovering, selecting, and producing biotechnology-derived drugs The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference: Provides an overview of biotechnology used in the drug development process Covers extensive applications, plus regulations and validation methods Features fifty chapters covering all the major approaches to the challenge of identifying, producing, and formulating new biologically derived therapeutics With its unparalleled breadth of topics and approaches, this handbook is a core reference for pharmaceutical scientists, including development researchers, toxicologists, biochemists, molecular biologists, cell biologists, immunologists, and formulation chemists. It is also a great resource for quality assurance/assessment/control managers, biotechnology technicians, and others in the biotech industry.

A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.