Developing a Transferrable Lyophilization Protocol using a MicroFD with LyoPAT
February 27, 2020
Presenter: Spencer Holmes, Application Engineer, Millrock Technology, Kingston, NY
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 seven 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. 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.
Learn about the 2 ½ day Lyophilization Process Development Workshop offered by Hooke College of Applied Sciences, a member of The McCrone Group.