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Process Modeling and Simulation
- 1. Process Qualification Ahmad Shahidi Years of Experience: 25 Active in ISPE baseline guide, PDA Education: MS Biochemical Engineering Functional Knowledge: Biological Centocor Manufacturing, Aseptic Filling, Critical Utility Systems Project Experience:
- 2. Process Modelling Goals Conformity to Client Business Need Memorandum Capability to Process 100% Biological Processes Ability to Detect Bottlenecks
- 3. Model Capabilities – Process Modelling Process Maximising productivity Sample generation Equipment usage Utilities Instantaneous utility demand Utility generator and storage sizing Tracking Wastes
- 4. Model Capabilities – Operations Tracking Costs (Activity and Allocated Costs) Logistics Stock usage Stock determination Intermediate product holding strategies Plant Activities Shift patterns Evaluate unscheduled events (contamination’s, equipment failures) Multi product manufacture
- 5. Design Assistance Fermentor Procurement Qualification Visits User Requirements Process Flow Diagrams Functional Specifications Review, Analyze, Correct and Augment Functional Specifications User Requirements Process Flow Diagrams
- 6. Confidential Client Business Need Memorandum Process Flexibility Batch Fed Batch Various titters Flexible DSP Asset Utilization Resources Competition Constraints
- 7. Models - How Do They Work Plans Schedule Takes account of activities Coordinates Support Activities Media preparation Buffer preparation Monitors Delays Adjust operations
- 8. Detect Constraints Equipment availability Media preparation & hold Buffer preparation & hold CIP WFI Process utilities Maximum supply rate Maximum generation rate Storage capacity
- 9. Typical Process Flow sheet
- 10. Automated Reactive Scheduling Delay Plan the Schedule Theoretical Minimum Times Run Simulation and Monitor Simulated Batch Cycle Times Adjust Production Schedule to Take Account of Delays Allow Manual Adjustment to Finish Optimisation
- 11. Input/Output Tabular Production data Results summary Utilities summary Database tables Graphical Gantt charts Utility flow profiles Utility storage profiles Equipment usage profiles
- 12. Gantt Charts – Production Schedule Shift Status Throughput Limiting Operation
- 13. Utility Profiles – Flow rate Max Demand Demand Exceeds Supply Supply Limit
- 14. Utility Profiles – Storage Critical Tank Level