Scaling Up Your Freeze Drying Protocol
Here at Millrock Technology, we often speak with research professionals eager to explore new ways to save time and money in their pharmaceutical and biotech freeze drying processes. Millrock Tech responded with a new patented innovation: the MicroFD® with LyoSim and LyoPAT®— a small-batch protocol development freeze dryer that uses between 3 and 37 vials to produce fully transferrable lyophilization protocols.
In this video webinar, Millrock’s T.N. Thompson demonstrates how the MicroFD with LyoSim and LyoPAT pharmaceutical freeze dryer system has built-in process analytical technology that allows you to collect all the critical process parameter information, and use that information to determine the best freeze drying protocol for your needs. One key feature of this is the LyoSIM ring, which can be used to track the product temperature in order to create center vials or edge vials. The ring’s heat flux sensor is mounted on the shelf itself and provides continuous, direct measurement of the heat flow going into the vials to determine critical process parameters such as mass flow and cake resistance. Unlike other measures, it’s done continuously and directly, eliminating the need to rely on calculations.
The MicroFD is designed to achieve several objectives in biotech and pharma freeze drying while using fewer vials: to develop a robust transferrable protocol, to determine the optimized product thermal history, and to determine critical process parameters like heat flow, mass flow, thermal conductivity of the vial, and cake resistance. This system allows us to monitor and control the lyophilization process unlike any other technology available.
Recently, the Journal of Pharmaceutical Sciences published an article entitled Representative Scale-down Lyophilization Cycle Development using a Seven Vial Freeze Dryer (MicroFD). The authors implemented and analyzed the use of a MicroFD with seven vials, focusing on its capability to accurately control heat transfer during lyophilization so that its Kv matches the Kv of vials in a larger laboratory scale unit — the Lyostar III. They concluded that “The ability to develop lyophilization cycles on the MicroFD that are representative of larger scales enables tremendous material and time savings, while supporting speed and convenience for current lyophilization development.”
Typically, use of the MicroFD micro freeze dryer would take you through an “Analyze” mode to determine your baseline, an “Optimize” mode to customize various parameters, and a “Transfer” mode to actually transfer the protocol using several different methods, such as extending the primary dry by 30% and, as used by one major pharmaceutical company, adjusting the LyoSIM temperature to simulate larger systems— another unique alternative to simply relying on calculations.
New features of the MicroFD micro freeze dryer include a mounted glove box that minimizes particle contamination and enables lower levels of supercooling during freeze drying, simulating a production environment.
T.N. Thompson offers a more detailed overview in this video. We at Millrock Technology welcome questions and feedback from our colleagues in the pharmaceutical and biotech freeze drying industry: phone 845-339-5700 or sales@millrocktech.com.
