Who Should Attend
This course is designed for personnel in the pharmaceutical, diagnostic, biomedical engineering and biotechnology industries responsible for the specification, development and production of lyophilized products, including:
• Biochemists
• R & D Personnel
• Chemists
• Pilot Plant Operations
• Chemical Engineers
• Production Supervisors
• Microbiologists
• Managers
• Pharmacists
• QA/QC
Those new to the industry and those with previous experience will find the course beneficial.
Description
This course is designed to provide participants with an up-to-date understanding of the theory and practice of lyophilization. Freeze-drying (lyophilization) will be presented and explained in physical, physicochemical, biochemical and engineering terms. Theory and practice will be interrelated and biotechnological and pharmaceutical applications will be emphasized. Participants should acquire a comprehension that transcends common disciplinary boundaries.
Topics covered will include vacuum physics, properties of water and ice, supercooling and supersaturation, phase behavior during freezing, differential thermal analysis, electrical resistance, glassy state behavior, collapse phenomena, desorption phenomena, product formulation, heat and mass transfer, development of freeze-drying cycles, end point determination, residual moisture, product stability, process scale-up, process control and optimization, Current Good Manufacturing Practice (cGMP), and validation. Fault finding and problem solving will be presented using case studies.