Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes.
Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering.
1. Cover image - p. iv 2. Title page - p. iv 3. Table of Contents - p. iv 4. Copyright - p. iv 5. Contributors - p. xix 6. Preface - p. xxiii 7. Chapter 1: New Product Development and Supply Chains in the Pharmaceutical Industry - p. xxiv 8. Chapter 2: The development of a pharmaceutical oral solid dosage forms - p. 26 9. Chapter 3: Innovative process development and production concepts for small-molecule API manufacturing - p. 65 10. Chapter 4: Plantwide technoeconomic analysis and separation solvent selection for continuous pharmaceutical manufacturing: Ibuprofen, artemisinin, and diphenhydramine - p. 84 11. Chapter 5: Flowsheet modeling of a continuous direct compression process - p. 120 12. Chapter 6: Applications of a plant-wide dynamic model of an integrated continuous pharmaceutical plant: Design of the recycle in the case of multiple impurities - p. 139 13. Chapter 7: Advanced multiphase hybrid model development of fluidized bed wet granulation processes - p. 157 14. Chapter 8: Global sensitivity, feasibility, and flexibility analysis of continuous pharmaceutical manufacturing processes - p. 187 15. Chapter 9: Crystallization process monitoring and control using process analytical technology - p. 213 16. Chapter 10: BioProcess performance monitoring using multiway interval partial least squares - p. 242 17. Chapter 11: Process dynamics and control of API manufacturing and purification processes - p. 259 18. Chapter 12: PAT for pharmaceutical manufacturing process involving solid dosages forms - p. 292 19. Chapter 13: Model-based control system design and evaluation for continuous tablet manufacturing processes (via direct compaction, via roller compaction, via wet granulation) - p. 315 20. Chapter 14: Fast stochastic model predictive control of end-to-end continuous pharmaceutical manufacturing - p. 351 21. Chapter 15: Advanced control for the continuous dropwise additive manufacturing of pharmaceutical products - p. 378 22. Chapter 16: Control system implementation and plant-wide control of continuous pharmaceutical manufacturing pilot plant (end-to-end manufacturing process) - p. 401 23. Chapter 17: Automation of continuous pharmaceutical manufacturing process - p. 430 24. Chapter 18: Implementation of control system into continuous pharmaceutical manufacturing pilot plant (powder to tablet) - p. 446 25. Chapter 19: Monitoring and control of a continuous tumble mixer - p. 469 26. Chapter 20: Flexible continuous manufacturing—based on S88 batch standards and object-oriented design - p. 487 27. Chapter 21: Planning pharmaceutical clinical trials under outcome uncertainty - p. 515 28. Chapter 22: Integrated production planning and inventory management in a multinational pharmaceutical supply chain - p. 550 29. Chapter 23: Optimal production of biopharmaceutical manufacturing - p. 567 30. Chapter 24: Perspective on PSE in pharmaceutical process development and innovation - p. 595 31. Index - p. 657
Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes.
Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering.
1. Cover image - p. iv 2. Title page - p. iv 3. Table of Contents - p. iv 4. Copyright - p. iv 5. Contributors - p. xix 6. Preface - p. xxiii 7. Chapter 1: New Product Development and Supply Chains in the Pharmaceutical Industry - p. xxiv 8. Chapter 2: The development of a pharmaceutical oral solid dosage forms - p. 26 9. Chapter 3: Innovative process development and production concepts for small-molecule API manufacturing - p. 65 10. Chapter 4: Plantwide technoeconomic analysis and separation solvent selection for continuous pharmaceutical manufacturing: Ibuprofen, artemisinin, and diphenhydramine - p. 84 11. Chapter 5: Flowsheet modeling of a continuous direct compression process - p. 120 12. Chapter 6: Applications of a plant-wide dynamic model of an integrated continuous pharmaceutical plant: Design of the recycle in the case of multiple impurities - p. 139 13. Chapter 7: Advanced multiphase hybrid model development of fluidized bed wet granulation processes - p. 157 14. Chapter 8: Global sensitivity, feasibility, and flexibility analysis of continuous pharmaceutical manufacturing processes - p. 187 15. Chapter 9: Crystallization process monitoring and control using process analytical technology - p. 213 16. Chapter 10: BioProcess performance monitoring using multiway interval partial least squares - p. 242 17. Chapter 11: Process dynamics and control of API manufacturing and purification processes - p. 259 18. Chapter 12: PAT for pharmaceutical manufacturing process involving solid dosages forms - p. 292 19. Chapter 13: Model-based control system design and evaluation for continuous tablet manufacturing processes (via direct compaction, via roller compaction, via wet granulation) - p. 315 20. Chapter 14: Fast stochastic model predictive control of end-to-end continuous pharmaceutical manufacturing - p. 351 21. Chapter 15: Advanced control for the continuous dropwise additive manufacturing of pharmaceutical products - p. 378 22. Chapter 16: Control system implementation and plant-wide control of continuous pharmaceutical manufacturing pilot plant (end-to-end manufacturing process) - p. 401 23. Chapter 17: Automation of continuous pharmaceutical manufacturing process - p. 430 24. Chapter 18: Implementation of control system into continuous pharmaceutical manufacturing pilot plant (powder to tablet) - p. 446 25. Chapter 19: Monitoring and control of a continuous tumble mixer - p. 469 26. Chapter 20: Flexible continuous manufacturing—based on S88 batch standards and object-oriented design - p. 487 27. Chapter 21: Planning pharmaceutical clinical trials under outcome uncertainty - p. 515 28. Chapter 22: Integrated production planning and inventory management in a multinational pharmaceutical supply chain - p. 550 29. Chapter 23: Optimal production of biopharmaceutical manufacturing - p. 567 30. Chapter 24: Perspective on PSE in pharmaceutical process development and innovation - p. 595 31. Index - p. 657