Developing a Transferable Lyophilization Protocol Using a Micro Freeze Dryer with Processing Analytical Technology
Abstract: This webinar will demonstrate how the MicroFD with LyoPAT can be used to both develop an optimized lyophilization protocol and then transfer the protocol to a pilot or production scale system. The MicroFD is an advanced, small-scale research and development freeze dryer that is capable of using as few as 7 vials to develop an optimized lyophilization protocol and facilitating the transfer of the developed cycle to a pilot or production scale freeze dryer.
Using a heat flux sensor, the LyoPAT software on the MicroFD is able to determine the critical process parameters that are relevant in developing and transferring a lyophilization protocol, such as Kv, Rp, and sublimation rate. The MicroFD is integrated with three LyoPAT optimization features, FreezeBooster controlled nucleation, AccuFlux post-nucleation heat flux control, and AutoDry closed-loop primary drying optimization, which collectively allow for the optimization of both the freezing and primary drying phases of a freeze-drying cycle.
- Remove the guesswork out of protocol development
- Use less of your valuable product for R&D
- Enables analysis and optimization with as few as 7 vials
- Determine Kv, Sublimation Rate, Rp and other critical process parameters
About Our Speaker:
Spencer Holmes is an Applications Engineer at Millrock Technology, where he works with the engineering team to continually develop and improve new tools for both analyzing the thermal dynamics of freeze-drying and optimizing lyophilization protocols. Spencer’s main area of focus is the MicroFD and LyoPAT, and he also instructs lyophilizer operators in how to use these technologies to analyze and optimize their lyophilization cycles. Spencer graduated from Northeastern University in 2017 with a BS in Chemical Engineering.
The critical process parameters that are determined by the LyoPAT software can then be used to transfer an optimized protocol to a larger pilot or production scale system.