Course Topics

11.17.20

Introduction to PCM: How to Adopt and Implement

• • • • Benefits in cost, robustness, integration, and faster product and process development
      • History of the revolution: Past, present and future
      • Capsule Direct Compression (CDC) and alternate methodologies
      • Twelve points to implementation

Introduction to the United States Pharmacopeia (USP) and a review of USP–NF Chapters impacting PCM Line

Material Properties

• Relevance of material properties in PCM: Failure modes
• Relevant material properties: Test methods
• Relations between different material properties
• Recommendations to construct useful material property databases

Unit Operations: Feeders, Blenders and Tablet Press

• Feeders and Blenders– types, operations, testing, evaluation and how material properties affect blending operations
• Feeder/Blender interactions
• Tablet Press compaction process and the effect of material properties on die filling and weight variability

Residence Time Distribution Considerations

• RTD concept, application and in-unit operations
• Effect on material properties
• Models and fitting for RTD

Process Analytical Technologies Considerations

• PAT essentials: Definition, types, benefits and limitations
• PAT necessary in a CDC: Architecture and considerations in assessment of blend uniformity
• Considerations for method development, models, calibration, validation and maintenance (segment includes PAT case study predicting dissolution)

Control Considerations

• Monitor process and controls and system benefits
• Design control systems

• Implement control systems - case studies: Model predictive control and RTD-based control

Flow Sheet Modeling and Line Integration

• Unit operation models, flow sheet modeling and integration
• Sensitivity and feasibility analysis
• Optimization