Process Qualification

    Ahmad Shahidi
        Years of Experience: 25
        Active in ISPE baseline
        guide, PD...
Process Modelling Goals

    Conformity to Client Business Need Memorandum

    Capability to Process 100% Biological Proc...
Model Capabilities – Process

   Modelling Process
         Maximising productivity
         Sample generation
         Eq...
Model Capabilities – Operations

   Tracking Costs (Activity and Allocated Costs)
   Logistics
          Stock usage
     ...
Design Assistance

   Fermentor Procurement
        Qualification Visits
        User Requirements
        Process Flow Di...
Confidential Client Business Need
Memorandum

   Process Flexibility
        Batch
        Fed Batch
        Various titte...
Models - How Do They Work


    Plans Schedule
         Takes account of activities
    Coordinates Support Activities
   ...
Detect Constraints

    Equipment availability
           Media preparation & hold
           Buffer preparation & hold
  ...
Typical Process Flow sheet
Automated Reactive Scheduling
                                Delay

   Plan the Schedule
  Theoretical Minimum
         T...
Input/Output

   Tabular
      Production data
      Results summary
      Utilities summary
      Database tables
   Grap...
Gantt Charts – Production Schedule



                                       Shift
                                      S...
Utility Profiles – Flow rate

                                 Max
                               Demand

                ...
Utility Profiles – Storage




             Critical Tank Level
Equipment Usage Profiles
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Process Modeling and Simulation

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Process modeling helps to Plan a Operation, takes account of all theoretical activities, coordinates support activities such as, media preparation or buffer preparation. It also monitors delays and adjust operations to random events such as contamination or equipment failure.

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Process Modeling and Simulation

  1. 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. 2. Process Modelling Goals Conformity to Client Business Need Memorandum Capability to Process 100% Biological Processes Ability to Detect Bottlenecks
  3. 3. Model Capabilities – Process Modelling Process Maximising productivity Sample generation Equipment usage Utilities Instantaneous utility demand Utility generator and storage sizing Tracking Wastes
  4. 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. 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. 6. Confidential Client Business Need Memorandum Process Flexibility Batch Fed Batch Various titters Flexible DSP Asset Utilization Resources Competition Constraints
  7. 7. Models - How Do They Work Plans Schedule Takes account of activities Coordinates Support Activities Media preparation Buffer preparation Monitors Delays Adjust operations
  8. 8. Detect Constraints Equipment availability Media preparation & hold Buffer preparation & hold CIP WFI Process utilities Maximum supply rate Maximum generation rate Storage capacity
  9. 9. Typical Process Flow sheet
  10. 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. 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. 12. Gantt Charts – Production Schedule Shift Status Throughput Limiting Operation
  13. 13. Utility Profiles – Flow rate Max Demand Demand Exceeds Supply Supply Limit
  14. 14. Utility Profiles – Storage Critical Tank Level
  15. 15. Equipment Usage Profiles

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