Process Understanding

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