This course serves as an introduction to the basics of freeze drying as it relates to the pharmaceutical, biological and diagnostic industries. The session will begin with a brief discussion of the scientific principles of freeze-drying and how these relate to modern equipment and component design. This will be followed by a discussion of the thermal properties of formulated products including the physical properties of the different materials routinely used for freeze-dried products (eutectic and glassy phases), and the modern methods used to characterize these different phases to determine glass transition temperatures and eutectic melting temperatures. Finally, the session will conclude with a discussion of how these thermal properties affect not only the choices made for developing a stable formulation, but also in how these properties drive cycle design and optimization.
By understanding the basics of freeze-drying and properly characterizing the thermal properties of each product, the development scientist can ensure that a quality product – meeting both chemical and physical quality specifications – can be produced in the shortest amount of time possible.