How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems

Oka, Sarang; Muzzio, Fernando

Elsevier Science Publishing Co Inc

04/2022

442

Mole

Inglês

9780128134795

15 a 20 dias

450

1. Introduction - Current State of the Technology 2. Conceptual Design 3. Material Characterization 4. Loss-in-weight feeding 5. Continuous powder mixing 6. Roller compaction 7. Wet granulation 8. Continuous Drying 9. Continuous tableting and coating 10. Role of Process Analytical Technology in Continuous Manufacturing 11. Process modeling 12. Integrated process control 13. Real Time Release and Testing 14. Risk Analysis, Sensitivity, and Optimization 15. Regulatory Expectations 16. The future of continuous processing
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AccPro II; Active pharmaceutical ingredient; Analysis of variance; Batch processing; Blend; Clustering analysis; Compaction pressure; Continuous manufacturing; Continuous processing; Continuous tableting; Control strategy; Critical quality attributes; Cystic fibrosis; Data-driven models; Design of experiment; Development and launch rig; Direct compaction; Dry granulation; Drying; Elastoplastic particles; Engineering toolbox; Equipment vendors; Feed factor; Film coating; Flowsheet model; Fluidized bed dryer; Fluidized bed; Granule characterization; High shear granulator; Hydrophobicity/wettability; In-process controls; KT35 feeder; Laws and regulations; Loss-in-weight feeders; Lubrication; Material properties; Milling; Model predictive control; Near-infrared spectroscopy; NSF funding; Optimization methods; Orkambi; Pharmaceutical applications; Pharmaceutical manufacturing; Pharmaceutical; Population balance modeling; Powder bed; Powder mixing; Principal component analysis; Process analytical technology; Process control; Process modeling; Product key; Quality by design; Quality; Real-time release testing; Relative density; Relative standard deviation; Residence time distribution; Rheometer; Roller compaction; Sampling; Simulation; Solid oral dose; Tablet presses; Throughput; Twin-screw granulator; US FDA; Wet granulation