Description
This course is designed to provide participants with an up-todate
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.<br><br>
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.
