Miniaturization in freeze drying is a relevant topic due to the limited availability and costs of API, especially in early development phases. A mini-freeze dryer (LyoCapsule™) consists of a small cylindrical inner chamber intended to freeze dry a reduced number of vials (typically seven 20R vials) and utilizes wall temperature control to emulate heat and mass transfer conditions typically encountered in larger scale. It is equipped with a full suite of process analytical technology (PAT) tools facilitating process development and successful scale-up / scale-down. Manometric Temperature Measurement (MTM) has already been proven as a key technology for the monitoring of freeze drying processes and evaluation of critical process and product parameters. Therefore, it serves as a useful tool to facilitate transfer of cycles between different freeze dryers and scales.
This webinar focuses on the applicability of MTM and SMART™ in the LyoCapsule™ freeze dryer, illustrated by several examples (such as wall temperature adjustment, amorphous and crystalline formulations and minimum load required for reliable values). Finally, the development of a robust and reproducible cycle in the mini-freeze dryer supported by advanced PAT tools is exemplarily demonstrated and cycle transfer to larger units is discussed.
Presented by Dr. Alexandra Braun, PhD Scientist at GILYOS
Speaker
Alexandra Braun, PhD
Scientist, GILYOS