Overview
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.
Why Should You Attend
To learn about the equipment and systems utilized in the freeze dry process, as well as ways to identify problems and optimize performance
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
4.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 4.0 credits towards a participant's RAC recertification upon full completion.
Agenda
Unit operations for freeze-dried pharmaceuticals
- Formulation
- Component prep
- Filling
- Lyo / 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
Speakers
Lisa Hardwick Thompson,
Pharmaceutical Lyophilization Expert ,
Lyo Blackboard LLCLisa Hardwick Thompson is a pharmaceutical technology consultant and educator with quality, regulatory, product/process development, and technical management experience at Cook Medical, Baxter, Catalent, and start-up businesses. During her career based in the pharmaceutical CMO sector, her expertise has been dedicated to the creation and/or transfer of clinical and commercial formulations and processes, specifically focused on lyophilized parenteral drug products. Her current role at Lyo Blackboard is devoted to consultation and education in the field of lyophilization.
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
The course will also benefit those in other departments who find lyophilization among their responsibilities.
