Key Topics Covered
Who Should Attend
This course is a Hands-on Training and Practical Workshop in Freeze Drying/Lyophilization.
It will cover theoretical and practical elements of Freeze Drying. We will be demonstrating the practical aspects of the course covering: formulating, characterizing, filling, loading and running a freeze drying cycle, and finishing with a critical examination of the finished product. The Participants will spend time on practical Freeze Drying (Sample Preparation, loading, checking primary, secondary drying) and Analytical Techniques in the Laboratory. We shall discuss secondary drying micro events, physics events, comparing between primary drying to secondary drying, vacuum control, and the most important topic is secondary drying end point determination. Participants will be working on the Live Freeze Dryer/Lyophiliser and Several Real-time case studies will be discussed.
Introduction to lyophilization:
- Freezing event – exothermic phase transfer
- Eutectic solutions freezing, measuring freezing temp.
- Freeze dried plugs structure
- Commercial lyophilizer operating and yearly output
Primary drying 2
- Critical parameters
- Freezing and primary drying in nature and at home
- What can go wrong? Case sharing
- Temperature distribution and correct design of PD
- Vapor flow pattern, sublimation rate, vapor trapping – the story which condenser tells. the condenser has different shapes and different efficiency technical problems.
- Vacuum control primary drying endpoint determination.
- Energy flow
- Pressure distribution, temperature distribution
- Vapor flow pattern,
- Vacuum control
- RH distribution
- Facilitating secondary drying
- What may go wrong?
- Professional involved in Freeze Drying/Lyophilization of Pharma/Biopharma Products
- Research and Development
- Process and analytical validation