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:

Process Modelling Goals
Conformity to Client Business Need Memorandum
Capability to Process 100% Biological Processes
Ability to Detect Bottlenecks

Model Capabilities – Process
Modelling Process
Maximising productivity
Sample generation
Equipment usage
Utilities
Instantaneous utility demand
Utility generator and storage sizing
Tracking Wastes

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

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

Confidential Client Business Need
Memorandum
Process Flexibility
Batch
Fed Batch
Various titters
Flexible DSP
Asset Utilization
Resources
Competition
Constraints

Models - How Do They Work
Plans Schedule
Takes account of activities
Coordinates Support Activities
Media preparation
Buffer preparation
Monitors Delays
Adjust operations

Detect Constraints
Equipment availability
Media preparation & hold
Buffer preparation & hold
CIP
WFI
Process utilities
Maximum supply rate
Maximum generation rate
Storage capacity

Typical Process Flow sheet

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

Input/Output
Tabular
Production data
Results summary
Utilities summary
Database tables
Graphical
Gantt charts
Utility flow profiles
Utility storage profiles
Equipment usage profiles

Gantt Charts – Production Schedule
Shift
Status
Throughput
Limiting
Operation

Utility Profiles – Flow rate
Max
Demand
Demand
Exceeds
Supply
Supply
Limit

Utility Profiles – Storage
Critical Tank Level

Equipment Usage Profiles