Biopharma Technology Ltd

Freeze Drying Microscopy

A rational approach to designing and developing freeze drying formulations and cycles requires information about how the product responds to different processing conditions. Understanding the behavior of a product throughout the freeze drying process ensures that cycles can be developed that are tailored to the specific needs of each product, making them efficient, safe, robust and reproducible.  Characterization also provides data which is useful for quality control and regulatory submissions. BTL uses a range of analyses to thoroughly characterize their product, including Freeze Drying Microscopy, DTA and Impedance Analysis, modulated DSC, Karl Fischer, and Frequency Modulated Spectroscopy.

Critical Temperatures for Freeze Drying
In crystalline solutions this is the eutectic point (Teu) and in amorphous products this is the collapse temperature (Tc). Information on how the product behaves as temperature increases is vital for successful freeze drying. Product that collapses during freeze drying can suffer from a range of problems including reduced shelf life, reduced activity and poor reconstitution.

Lyostat FDM
Lyostat FDM analysis uses just 2µl and is typically complete in under an hour. Lyostat is supplied fully validated as a complete working system against a series of standard solutions. full installation and training of the lyostat freeze drying microscope is offered as standard. Uniquely, as well as instructing correct use of the equipment, our training provides practical tuition on interpretation of results from scientists with in-depth knowledge of freeze drying. Installation and operation qualification (IQ/OQ) packages are also available, and can be customised to bespoke specifications if required.