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, from freezing, primary and secondary drying to what is required to successfully move the cycle to scale-up for production. 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, cycle development and scale up for freeze drying process (including the iterative approach and also the use of “new” SMART software), and the use of PAT (Process Analytical Technology) for monitoring the process. We will be including a presentation of how to approach the submissions to regulatory authorities.
Microscopy and thermal analysis in formulation characterisation
Cycle development & scale-up
PAT in freeze-drying process
Analysing the freeze-dried product