PDA EU00171 Optimize Your Freeze-drying Process
A successfully optimized freeze-drying cycle will provide reliable, safe processing in an efficient manner. Each stage of the process – freezing, primary drying and secondary drying – poses its own challenges. Many factors influence the design of the cycle, including the specific thermal characteristics of the product, the type and amount of product per batch or container, and the capabilities of the processing equipment to be used.
This training course provides an overview of how to develop an optimized freeze-drying process. It will go through each critical stage required to optimize a cycle including: an overview of the freeze drying process, formulation design of freeze dried products, characterization of the formulation in the frozen state prior to freeze drying, and cycle development, including the iterative approach, and the use of PAT (Process Analytical Technology) for monitoring the process.
Welcome, Opening Remarks and Introductions
Introduction to Freeze-Drying
Factors Effecting the Rate of Sublimation
Typical CQAs and Excipients in Freeze Dried Products
Frozen State Characterization
Overview of Process Analytical Technology Used in Monitoring Primary Drying
Cycle Development and Scale Up: Use of the Iterative Approach
Cycle Development and Scale up: Use of the Iterative Approach
Round-up Discussion and Questions
End of Course