Now, obviously the sample forms a solid, but which type of solid it forms is extremely critical in how we design the cycle both in primary and secondary drying because the different phases that can form can behave, and do behave, very differently, so generally what happens is as we freeze the sample down, an aqueous sample-again, sometimes we may be working with co-solvent-but if we’re working with an aqueous system, when we start to freeze the sample, we’re going to hit a certain temperature where we’re going to get a phase change: meaning, ice is going to start crystallizing out of our product. Now when we talk about characterizing a system, basically, we’re doing a couple of things.
So what we’re going to do is kind of walk through-over the next fifteen minutes or so for my part-talking to you about why we would do the thermal characterization why we do the microscopy, and how it can really benefit us not only in how we develop the cycle and optimize the cycle, but also, down the road, if we have problems with a cycle, how this really good tool-set of tools-for diagnosing and correcting failed cycles or failed products. And one of those pieces of equipment that we use is the freeze dry microscopy system.
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It’s not the trial and error guesswork that we used to do. Now, you know within the past twenty years-maybe in fifteen to twenty years-there’s been a lot of new technologies that have been developed that are putting the science into freeze drying. Now for those of you who maybe have been working in lyophilization for a number of years, you know, in the earlier days, the method for optimizing a cycle was just pretty much open the door to the freeze dryer, put your product in, and push a button, and hope that at the end of the day you get something that at least works, and again, you may burn through 20 to 30 runs, and a lot of product. This is just kind of a general overview of how we incorporate a freeze dry microscopy system as part of complete thermal characterization. Okay, thank you Chuck, and like Chuck said, I’d like to welcome everybody to the webinar. Without further ado, I’d like to turn the program over to Dr. If you’re interested in freeze dry services or freeze dry microscopy equipment, there will be a contact information slide provided at the end of this presentation, and today’s webinar will be available on The McCrone Group’s website-it will be recorded so you can reference that at your leisure at a later date. They’re also developing a hands-on course on lyophilization cycle development and optimization, which will be offered later in the year at Hooke College of Applied Sciences (HCAS). For more than a decade, Ruben has installed microscope systems all over the world, and he also specializes in the installation and use of Linkam thermal equipment, including what he’s going to talk about today-the Linkam FDCS196 freeze dry system.īoth Jeff and Ruben will field questions from the audience immediately following today’s presentation.
Our other speaker that we have with us is Ruben Nieblas, of McCrone Microscopes & Accessories. He’s available for speaking engagements and consulting services on these topics that he is going to discuss today.
Jeff specializes in formulation development, lyophilization cycles, and thermal characterization studies, including freeze dry microscopy and DSC. He’s the founder and CEO of AB Bio Technologies. Thanks, everybody, for attending today’s webinar on utilizing Freeze Dry Microscopy as Part of a Complete Thermal Characterization Study for Optimizing Lyophilization Development.