Wednesday 28 FEBRUARY, 2024

Session 1 Introduction to Freeze Drying & Equipment Design
Session 2 Formulation Development & Characterization
Session 3 Cycle Development
Session 4 Practical Advice, Troubleshooting and Cake Appearance Issues


Thusday 29 FEBRUARY, 2024

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Yossi Shapira

Founder – CLL

BSC in biology Tel Aviv University, A member of the ISLFD, bringing 43 active lyophilization years, most of them in Teva Pharmaceutical Industries. Yossi experienced a large variety of lyophilized products: vaccines, steroids, anticancer products, antibiotic parenterals, bulk API organic solvents, binary solutions, peptides, tissue culture, biological specimen for museal purpose etc.All the above was performed in a large variety of lyophilizers constructed by8357 different vendors, starting from the small benchtop through pilot size to commercial size to the largest pharmaceutical Ray con.

Within his functions FD processes: development, tech transfer, troubleshooting, optimization, lyophilizers installation and testing. Recently he founded the CLL Company. CLL offers lyophilization services and lyophilization training with customer’s equipment in customer’s premises.

Yossi occasionally presents in ISLFD, in lyotalk, in PDA conferences. He leads home lyophilization courses and workshops

Overview : 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, characterising, lling, loading and running a freeze drying cycle, and fnishing with a critical examination of the fnished 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.

Course Agenda : Introduction to lyophilisation

  • 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
  • Vapor fow pattern, sublimation rate, vapor trapping – the story which condenser tells. the condenser has different shapes and different efciency technical problems.

Secondary drying :

  • Pressure distribution, temperature distribution
  • Vapor flow pattern,
  • Vacuum control
  • RH distribution
  • What may go wrong?
  • Secondary drying end point determination.

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