This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle.
This webinar will begin with a discussion of the physical properties of materials that are commonly used to formulate freeze-dried products, and the impact that these materials can have on how products freeze-dry (in regards to the physical and chemical integrity).
This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle. In the past, a "trial and error" approach was routinely used as the means of cycle design, often resulting in products that were substandard or cycles that were prohibitively long and expensive.
This webinar will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-died products in vials, to foods. Understanding the different techniques, their limitations, and proper execution will result in more accurate and precise moisture results, which translates into better quality products with longer shelf lives.
Monitoring and controlling residual moisture in powders, lyophilized solids, foods, etc can be a critical factor in achieving and maintaining quality products throughout their expected shelf life. Improper levels of moisture in products can result in poor powder flow properties, spoilage, polymorph changes, changes in compaction properties, microorganism growth promotion, higher degradation kinetics, and in the case of freeze-dried products, loss of physical structure and changes in reconstitution properties.
Optimized lyophilization cycle design can be an extremely difficult and daunting task for the scientist that is unskilled or under skilled in the process. This is becoming even more prevalent as many of the molecules coming out of discovery are more complex, unstable, and require a very specific, multi component formulation to impart not only good chemical stability and physical stability to the active ingredient, but also good physical stability to the dried solids themselves.