Lyophilization Technology - Practical Application of the Scientific Principles

This course is designed to provide attendees with a practical approach to understanding the scientific and engineering principles of lyophilization. The topics discussed during the course will be presented to explain the physical, physicochemical, biochemical, and engineering principles of the science and engineering behind modern freeze-drying. The practicality of the course allows the attendees to get a firm understanding of the theoretical applications of freeze-drying and how these can be easily used and applied to their day to day lyophilization projects.

Topics covered will include:

• History of lyophilization
• Properties of water and ice
• Supercooling and supersaturation
• Phase behavior during freezing
• Thermal characterization
• Annealing
• Visco-elastic properties of amorphous phases
• Collapse phenomena
• Vacuum physics
• Product formulation
• Heat and mass transfer
• Cycle development
• End point determination
• Residual moisture
• Process scale-up and sonic water vapor flow
• IQ/OQ/PQ
• Process control and optimization
• Fault finding and problem solving of systems and formulations
• Freeze dryer mechanical and control systems
• Recipe development
• Following the process

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Edward W. Sunbery, R.Ph. is a pharmaceutical technology consultant. His fields of expertise include product development, engineering and technical management experience with such organizations as Merck, Onco Therapeutics, Warner Lambert and Wyeth Laboratories.

Mr. Sunbery’s product-development experience includes the design and execution of pre-formulation studies, analytical methods development and product evaluations from pre-clinical studies through scale-up – including process and cleaning validation. This experience includes both oral and topical forms – as well as injectable forms of liposomes, solutions/suspensions and lyophilized products.

His engineering experience includes facility/equipment design, start up, trouble shooting and qualification. In addition, he has technical-management experience in the preparation and execution of validation master plans, factory-acceptance tests and equipment-qualification protocols. Mr. Sunbery also holds multiple patents for the detection of product tampering.