Process systems engineering for pharmaceutical manufacturing
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| Other Authors: | , |
|---|---|
| Format: | eBook |
| Language: | English |
| Published: |
Amsterdam, Netherlands :
Elsevier,
2018.
|
| Series: | Computer-aided chemical engineering ;
41. |
| Subjects: | |
| ISBN: | 9780444639660 0444639667 9780444639639 |
| Physical Description: | 1 online resource |
Cover
Table of contents
| LEADER | 11330cam a2200445 i 4500 | ||
|---|---|---|---|
| 001 | kn-on1029054898 | ||
| 003 | OCoLC | ||
| 005 | 20240717213016.0 | ||
| 006 | m o d | ||
| 007 | cr cn||||||||| | ||
| 008 | 180320s2018 ne o 001 0 eng d | ||
| 040 | |a N$T |b eng |e rda |e pn |c N$T |d OPELS |d N$T |d UAB |d MERER |d OCLCF |d D6H |d OCLCQ |d OCLCA |d ESU |d U3W |d LVT |d YDX |d UMR |d STF |d KNOVL |d S2H |d OCLCO |d OCLCQ |d OCLCO |d K6U |d OCLCQ |d SFB |d OCLCQ |d OCLCO |d OCLCL |d SXB |d OCLCQ | ||
| 020 | |a 9780444639660 |q (electronic bk.) | ||
| 020 | |a 0444639667 |q (electronic bk.) | ||
| 020 | |z 9780444639639 |q (print) | ||
| 035 | |a (OCoLC)1029054898 | ||
| 245 | 0 | 0 | |a Process systems engineering for pharmaceutical manufacturing / |c edited by Ravendra Singh and Zhihong Yuan. |
| 264 | 1 | |a Amsterdam, Netherlands : |b Elsevier, |c 2018. | |
| 300 | |a 1 online resource | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 490 | 1 | |a Computer aided chemical engineering ; |v volume 41 | |
| 500 | |a Includes index. | ||
| 505 | 0 | |a Front Cover -- Process Systems Engineering for Pharmaceutical Manufacturing -- Copyright -- Contents -- Contributors -- Preface -- Chapter 1: New Product Development and Supply Chains in the Pharmaceutical Industry -- 1. Introduction -- 2. Typical Features of Pharmaceutical Industry -- 2.1. Analysis of the Product Development Process -- 2.2. Life Cycle of a Drug -- 2.3. Drug Market Features -- 2.4. Supply Chain Management -- 2.4.1. Typical features of pharmaceutical supply chains -- 2.4.2. Process systems engineering contribution -- 3. Management of Product Development Pipeline -- 3.1. Methodological Approaches -- 3.2. Related Optimization Works -- 3.2.1. Optimization of early-phase testing -- 3.2.2. Optimization of portfolio management -- 3.2.3. Clinical trial supply chain management (CTM) -- 4. Capacity Planning -- 5. Management of the Whole Pharmaceutical Supply Chain -- 6. Conclusions -- References -- Chapter 2: The development of a pharmaceutical oral solid dosage forms -- 1. Introduction -- 2. Pharmaceutical Preformulation and Its Significance in the Development of Solid Dosage Forms -- 2.1. Solid-State Properties -- 2.2. Solubility -- 2.2.1. pKa -- 2.2.2. Partition coefficient (log P) -- 2.3. Dissolution Studies -- 2.4. Stability Studies -- 2.5. Drug-Excipient Compatibility Studies -- 2.6. Physical Properties of Pharmaceutical Solids -- 3. Drug Product Manufacturing -- 3.1. Diluents -- 3.2. Binders -- 3.3. Disintegrating Agents -- 3.4. Lubricant -- 3.5. Coating Materials -- 3.5.1. Sugar coating -- Sealing -- Subcoating -- Smoothing -- Coloring -- Polishing -- 3.5.2. Film coating -- 4. Manufacturing Methods for Oral Solid Dosage Form -- 4.1. Direct Compression (Shangraw et al., 1989) -- 4.2. Granulation -- 4.2.1. Dry granulation -- 4.2.2. Wet granulation -- High shear mixture granulation (Gokhale et al., 2005). | |
| 505 | 8 | |a Fluidized Bed Granulation (Parikh and Mogavero, 2005) -- 5. Type of Unit Operation -- 5.1. Pharmaceutical Process Design Methodology -- 5.2. Unit Operation Design -- 5.2.1. Crystallization -- 5.2.2. Filtration and drying -- 5.2.3. Screening and size reduction -- 5.2.4. Blending -- 5.2.5. Tabletting process -- 6. Batch Versus Continuous Processing -- 7. Process Analytical Technology -- 8. Conclusions -- References -- Chapter 3: Innovative process development and production concepts for small-molecule API manufacturing -- 1. Introduction -- 2. Pharmaceutical Production Processes -- 2.1. Production of High-Molecular-Weight Pharmaceutical Products -- 2.2. Production of Low-Molecular-Weight Pharmaceutical Products -- 3. Innovative Solutions to Accelerate the Development of API Production Processes -- 3.1. Virtual Experimentation -- 3.2. Databases and Property Prediction -- 3.3. Template Processes -- 3.4. Summary -- 4. Innovative Solutions to Improve API Production Processes -- 4.1. Process Analytical Technology -- 4.2. Process Integration and Intensification -- 4.3. Solvent Selection -- 4.4. Biocatalysis -- 4.5. Flow Chemistry -- 5. Example: Sitagliptin -- 6. Future Perspectives -- References -- Chapter 4: Plantwide technoeconomic analysis and separation solvent selection for continuous pharmaceutical manufacturing ... -- 1. Introduction -- 2. CPM of Ibuprofen, Artemisinin, and Diphenhydramine -- 2.1. Continuous-Flow Syntheses -- 2.2. Batch and Continuous Separation Schemes -- 3. Economic Analysis -- 4. Results and Discussion -- 4.1. API Recoveries and Material Efficiencies -- 4.1.1. Ibuprofen (IBU) -- 4.1.2. Artemisinin (ART) -- 4.1.3. Diphenhydramine (DPH) -- 4.2. Economic Analysis -- 4.2.1. CapEx and OpEx Savings -- 4.2.2. Sensitivity Analyses: NPV, ROI, and PBP -- 5. Conclusions -- Acknowledgments -- Appendix A. API Recoveries and PMIs. | |
| 505 | 8 | |a Appendix B. CapEx, OpEx and Sensitivity Analyses -- References -- Chapter 5: Flowsheet modeling of a continuous direct compression process -- 1. Introduction -- 1.1. Flowsheet modeling -- 2. Continuous Direct Compression -- 2.1. Powder Feeding -- 2.2. Methods of Modeling for Powder Feeding -- 2.2.1. Perfect feeding -- 2.2.2. Perfect feeding with random variation -- 2.2.3. Feeding with control strategy -- 2.2.4. Feeding with process parameters and material properties -- 2.3. Powder Blending -- 2.3.1. Convective blenders -- 2.3.2. Gravity-driven blenders -- 2.4. Modeling Methods for Powder Blending -- 2.4.1. Population balance equation -- 2.4.2. Convolution -- 2.4.3. Tanks in series -- 2.5. Tablet press -- 2.6. Modeling methods for the Tablet Press -- 2.6.1. Feed frame -- 2.6.2. Tablet compaction -- References -- Further Reading -- Chapter 6: Applications of a plant-wide dynamic model of an integrated continuous pharmaceutical plant: Design of the rec ... -- 1. Introduction -- 2. Process Description -- 3. Plant-Wide Model -- 4. Results and Discussions -- 4.1. Impact of Wash Factors -- 4.2. Impact of Purge Ratio -- 5. Conclusions -- References -- Chapter 7: Advanced multiphase hybrid model development of fluidized bed wet granulation processes -- 1. Introduction to Granulation Modeling -- 1.1. Fluid Bed Model Development: Multiphase Flow and Granulation -- 1.2. Different Modeling Techniques -- 1.2.1. Population balance modeling -- 1.2.2. Discrete element modeling -- 1.2.3. Computational fluid dynamics -- 1.2.4. Coupled CFD-DEM modeling -- 2. Multiphase Model Development and Implementation: Fluidized Bed Wet Granulation -- 2.1. CFD-DEM: Model Development -- 2.1.1. Flow and energy models -- 2.1.2. Lagrangian multiphase models -- 2.1.3. Implicit unsteady-state model -- 2.1.4. Lagrangian passive scalar model -- 2.2. PBM: Compartmental Model Development. | |
| 505 | 8 | |a 2.2.1. Aggregation -- 2.2.2. Breakage -- 2.2.3. Liquid addition -- 2.2.4. Consolidation -- 2.2.5. Particle flux between compartments -- 2.3. CFD-DEM-PBM: Model Implementation -- 3. Results and Discussion -- 3.1. CFD-DEM Simulation Results -- 3.1.1. Effect on particle velocities -- 3.1.2. Effect on particle temperatures -- 3.1.3. Effect on collision frequency and circulation of particles -- 3.1.4. Effect on the particles residence time in spray zone -- 3.2. PBM Results and Validation of Hybrid Model -- 4. Summary -- References -- Chapter 8: Global sensitivity, feasibility, and flexibility analysis of continuous pharmaceutical manufacturing processes -- 1. Introduction -- 2. Global Sensitivity Analysis -- 2.1. Methods -- 2.1.1. Screening methods -- 2.1.2. Regression-based methods -- 2.1.3. Variance-based methods -- Sobol' method -- FAST and eFAST method -- 2.1.4. Metamodel-based methods -- 2.2. Visualization of Sensitivity Results -- 3. Feasibility and Flexibility Analysis -- 3.1. Methods -- 3.1.1. Traditional simulation-based approach -- 3.1.2. Surrogate-based adaptive sampling approach -- Kriging-based adaptive sampling approach -- RBF-based adaptive sampling approach -- 3.2. Visualization of Results -- 3.3. Extensions -- 4. Software -- 5. Conclusion and Future Perspectives -- Acknowledgments -- References -- Chapter 9: Crystallization process monitoring and control using process analytical technology -- 1. Introduction -- 2. QbD and PAT -- 3. Liquid- and Solid-Phase Monitoring -- 3.1. ATR-FTIR and Ultraviolet-Visible Spectroscopy -- 3.2. Conductivity Measurements -- 3.3. Refractive Index Measurement -- 3.4. Turbidity Measurement -- 3.5. FBRM -- 3.6. PVM and Endoscopy -- 3.7. Raman Spectroscopy -- 3.8. Acoustic Spectroscopy (Ultrasound) -- 4. Monitoring and Control of Batch Crystallization Processes. | |
| 505 | 8 | |a 4.1. Optimal Switching Between Nucleation and Seed Ripening Using Control Charts -- 4.2. Concentration Feedback Control -- 4.3. ADNC -- 4.4. Polymorphic Feedback Control -- 4.5. Polymorphic Control by Optimal Solvent Selection -- 5. Monitoring and Control of Continuous Crystallization Processes -- 5.1. ADNC of Continuous Crystallization Processes -- 5.2. Polymorphic Control in Continuous Crystallization -- 5.3. Encrustation Monitoring in Continuous Crystallization -- References -- Further Reading -- Chapter 10: BioProcess performance monitoring using multiway interval partial least squares -- 1. Motivation and Background -- 2. Combining data Unfolding and Interval Splicing Techniques -- 2.1. Three-Dimensional Data Unfolding -- 2.2. Combining Data Unfolding and Interval Splicing -- 3. Fed-Batch Penicillin Simulator Prediction and Fault Monitoring -- 3.1. Fed-Batch Penicillin Production Process Simulator Overview -- 3.2. Prediction and Process Monitoring -- 4. Prediction and Monitoring Results -- 4.1. Predictive Model Performance -- 4.2. Process Performance Monitoring -- 5. Conclusions -- Funding Sources -- References -- Chapter 11: Process dynamics and control of API manufacturing and purification processes -- 1. Introduction, Objectives, and Background -- 2. Integrated Process -- 3. Model Development -- 3.1. Population Balance Model -- 3.2. Crystallizer -- 3.3. Filter -- 3.4. Dryer -- 3.5. Mixer -- 3.5.1. DEM simulation -- 3.6. Principal Component Analysis-Based ROM -- 3.7. Numerical Technique -- 4. Design Strategy of the Hybrid MPC-PID and PID Only Control System -- 4.1. Hybrid MPC-PID Design -- 4.2. PID Only Design -- 4.3. Design of Controller -- 4.4. MPC-PID Controller Equations -- 5. Performance of the Hybrid Control System -- 5.1. Comparison of Hybrid MPC-PID Scheme With PID Only Scheme -- 6. Conclusions -- Acknowledgments -- References. | |
| 506 | |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty | ||
| 590 | |a Knovel |b Knovel (All titles) | ||
| 650 | 0 | |a Systems engineering. | |
| 650 | 0 | |a Pharmaceutical industry |x Management. | |
| 650 | 0 | |a Manufacturing processes. | |
| 655 | 7 | |a elektronické knihy |7 fd186907 |2 czenas | |
| 655 | 9 | |a electronic books |2 eczenas | |
| 700 | 1 | |a Singh, Ravendra |c (Research assistant professor), |e editor. |1 https://id.oclc.org/worldcat/entity/E39PCjK3FH8TpBykc4mhRGpbgq | |
| 700 | 1 | |a Yuan, Zhihong |c (Assistant professor of chemical engineering), |e editor. |1 https://id.oclc.org/worldcat/entity/E39PCjvft3fpyxdybPjDt3KcRq | |
| 830 | 0 | |a Computer-aided chemical engineering ; |v 41. | |
| 856 | 4 | 0 | |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpPSEPMVC1/computer-aided-chemical?kpromoter=marc |y Full text |
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