Process understanding : for scale-up and manufacture of active ingredients /: for scale-up and manufacture of active ingredients. (2011)

• Record Type: Book
• Further Information: Note: Edited by Ian Houson.
• Other Names: Houson, I. N (Ian N.)
• Contents: Preface; ; QUALIT Y BY DESIGN; History; Defining Product Design Requirements and Critical Quality Attributes; The Role of Quality Risk Management in QbD; Design Space and Control Strategy; Quality Systems; ; ROUTE AND PROCESS SELECTION; Introduction; Route Evaluation; Factors to Consider; Route Selection; Process Selection; Summary; ; CRITICAL STAGES OF SAFETY ASSESSMENT IN PROCESS DESIGN AND SCALE-UP; Reaction Safety Concepts; Pre-Laboratory Safety Studies; The Synergies of Safety and Optimization -; Together; Establishing a Reliable Basis of Safety for Scale-Up; Flammability Hazards; Summary; ; UNDERSTANDING THE REACTION; Introduction; Process Complexity; Topics for Data Acquisition; Reaction Profiles; Reaction Pictures; Ionic Equilibria and Reaction Selectivity; Kinetics; Catalyzed Processes; The Rate-Determining Step; Mixing in Chemical Reactors; Mixing Theory; Multiphase Processes; Mass Transfer Theory; Mass Transfer and Mixing Requirements in Multiphase Systems; Concepts of Structure and Scale for Equipment Selection; Conclusion; ; USE OF MODELS TO ENHANCE PROCESS UNDERSTANDING; Introduction; The Process Characterization Elements of a Chemical Reaction; The Impact of Modeling; Understanding the Chemistry; Physical Rates (The Elements of Mass Transfer); Summary and Outlook; ; SCALE-UP OF CHEMICAL REACTIONS; Introduction; Case Study -; Batch Hydrogenation; Scale-Up of Stirred Tank Reactors (STRs); Stirred Tank Scale-Up; Chemistry Effects in Scale-Up; Achieving Process Understanding for Reactor Scale-Up; Reactor Selection; Exploiting Process Understanding in Scale-Up; Conclusions; ; PROCESS UNDERSTANDING -; CRYSTALLIZATION; Introduction; Crystallization Processes; Batch Crystallization Techniques; Process Control of Crystallization; Analytical Techniques for Product Characterization; Conclusions; ; KEY TECHNOLOGIES AND OPPORTUNITIES FOR INNOVATION AT THE DRUG SUBSTANCE -; DRUG PRODUCT INTERFACE; Introduction; Opportunities for Innovation; Crystallization; Selected Manufacturing Technologies at the Drug Substance -; Drug Product Interface; Analytical Techniques; Conclusions; ; PROCESS UNDERSTANDING REQUIREMENTS IN ESTABLISHED MANUFACTURE; Introduction; The Status Quo; Risk and Reward; Terms and Definitions; Process Understanding Requirements; Method Development and Installation; Statistical Process Control; Automation; Conclusion; ; PLANT DESIGN; Introduction; Developing Process Concept to Plant Concept; Regulations; Infrastructure Design; Portfolio Analysis and Asset Planning; ; CONTRACT MANUFACTURE; Introduction; Why Contract?; The Contractor; The Client; Technology Transfer; What Makes a Good Technical Package?; Client Process Understanding; Case Studies; Winning and Delivering the Project; Project Timing; Challenges of Multiproduct Plant Scheduling against an Uncertain Background; Conclusion; ; WHOLE PROCESS DESIGN; Process Understanding for Whole Process Design; Process Outcomes; Organization of the Design Activity; Risk and Uncertainty in WPD; Whole Process Representations; Decision Making in WPD; Summary;
• Publisher Details: Place of publication not identified : Wiley-VCH
• Publication Date: 2011
• Extent: 1 online resource (370 pages)
• Subjects: 660.28; Chemical processes
• Languages: English
• ISBNs: 9783527637157
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.