A rational, knowledge-based approach to designing and developing successful freeze drying formulations and cycles requires information about how the product responds to different processing conditions. Candidate formulations should be analyzed in terms of their visible physical structure, thermal characteristics and frozen state mobility, in order to gain a sufficient understanding of its behaviour throughout the freeze drying process. This ensures that cycles can be developed that are tailored to the specific needs of every product, making them efficient, safe, robust and reproducible.
Analytical Lyo Instruments
Biopharma Group specialists have designed and developed three advanced analytical instruments – the Lyostat freeze-drying microscope, the Lyotherm DTA and impedance analyser and the MicroPress specifically to aid those employing freeze drying technologies within their production or research projects as well as being involved in the development of a compatible DSC imaging stage. Since the first model was developed and sold, these instruments have been improved and updated to give the current instruments which are described and the in the overview brochure below:
Lyostat Freeze Drying Microscope
Lyostat identifies critical formulation parameters including collapse temperature (Tc), eutectic melting temperature (Teu), crystallisation phenomena, the potential for skin/crust formation, and the effects of annealing on ice crystal growth, solute structure and critical temperature. The Lyostat freeze drying microscope is PC controlled to provide sophisticated image and data capture along with analysis functions, which allows the user to determine the failure point of their formulations.
Lyotherm Frozen State Analysis
Lyotherm provides information about the behavior of your formulation in the frozen state, identifying changes in molecular mobility and giving an indication of thermal events such as glass transitions, crystallisation events and eutectic melting.
The MicroPress was designed and developed by the Biopharma Group specialists as a solution for determining the robustness (Young’s Modulus) and strength (max stress at failure) of lyophilized cakes. MicroPress uses a linear actuator to gently compress the cake while a load cell accurately measures the force applied. The resulting stress-strain profile captured by the integrated software is then exportable to Microsoft Excel for further interpretation and analysis.
By performing this analysis, the user can determine how the cake will behave during storage and shipment.
The application notes below can help with how MicroPress can be used with your products: