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.
GUIDELINES ON USEFUL FORMS IN FREIGHT FORWARDING (F) Danny Diep Toh MBA.pdf
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
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
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