PDA 153 Scale-up and Robustness Testing of Lyophilization Cycles

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 live eLearning training course provides an overview of how to develop an optimized freeze-drying process as well as 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 to include:

• 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 the use of “new” SMART software)
• Use of Process Analytical Technology (PAT) for monitoring the process

1. Gain a basic understanding of the freeze-drying process, together with the factors that influence the product and process
2. Characterize to determine a product critical temperature prior to freeze-drying
3. Review formulation development to gain understanding of typical excipients and their purpose in a formulation
4. Explain typical CQAs in freeze-dried products, what factors influence these attributes, and methods of monitoring and controlling attributes
5. Develop a freeze-drying process using the traditional iterative (stepwise) approach and how this compares to the use of SMART software
6. Gain a basic understanding of typical PAT to monitor the freeze-drying process and when primary drying is complete