Workshop Overview
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.