This course will cover manufacturing operations for freeze-dried pharmaceuticals, as well as instruct attendees about the equipment, systems, subsystems, and instrumentation utilized in a commercial lyophilizer. Performance limitations will be described, as well as techniques to optimize equipment capability and freeze-dry cycles.

Learning Objectives:-

• Understanding of manufacturing process
• Identification of all systems and subsystems within a freeze dryer
• Proper use of freeze dryer instrumentation
• Understanding and examples of Process Analytical Technologies
• Characterization of process control limitations
• Use of design space for primary and secondary drying

Areas Covered:-

Unit operations for freeze-dried pharmaceuticals

• Formulation
• Component prep
• Filling
• Lyon /capping
• Inspection
• Labeling and packaging

Freeze-Drying equipment

• Basic components 
• Systems and subsystems
• Sequence of operations

Instrumentation

• Temperature and pressure measurements
• Process Analytical Technology (pressure, moisture, gas flow, TDLAS, FM spectroscopy, NIR)

Performance

• Sources for process control imprecision (variables affecting heat and mass transfer)
• Choked flow
• Measurement of equipment capability
• Freezing Optimization via controlled nucleation
• Cycle optimization via design spaces for primary and secondary drying

The course will also benefit those in other departments who find lyophilization among their responsibilities.

Who Should Attend:-

• Professionals in Quality Control
•  Quality Assurance
• Validation
• R&D Groups
• Biochemists
• Pilot Plant Operators
• Chemical Engineers
• Production Supervisors
• Chemists
• Equipment Maintenance
• Mechanical Engineers