The key to successful freeze drying is pre and post process analysis.
Lyostat freeze drying microscope
Freeze drying microscopy is the standard technique for identifying many key temperatures such as melting and freezing point and collapse temperature. This information is vital for effective freeze drying cycles to be be developed quickly, without time-consuming trial and error. The data provided by freeze drying microscopy is also invaluable for regulatory submissions.
Biopharma’s Lyostat freeze drying microscope is PC controlled to provide sophisticated image and data capture and analysis functions. Uniquely, installation and training is conducted by a scientist familiar with use of the system on a day-to-day basis. Questions about operation and interpretation can therefore be answered by someone with first-hand experience.
Lyotherm frozen state analysis
Biopharma’s Lyotherm is an analytical instrument unique to Biopharma. Freeze drying formulations combine many elements and can exhibit complex freeze drying behaviour that can impact on long-term stability but may not be visually apparent. By using a combination of DTA and impedance analysis, Lyotherm provides information about the behaviour of your formulation in the frozen state, identifying changes in molecular mobility and giving an indication of thermal events such as crystallisation. This information is vital to ensure that your product is not undergoing any unseen adverse changes during the freeze drying process.
Headspace Moisture Analysis
Frequency Modulated Spectroscopy (FMS) is a non-destructive analysis for the pressure and moisture content within the headspace of a sealed vial.
Light from a near-infrared diode laser is tuned to match an internal absorption frequency of the water molecule and passed through the empty container headspace above the product. The amount of laser light absorbed is proportional to the moisture concentration in the headspace and the width of the absorption profile gives the total headspace pressure. The measurement method is rapid and non-destructive. This makes FMS ideal for monitoring large amounts of product for complete-batch quality monitoring, or analysing the same product repeatedly over time, for example for stability studies or moisture degradation studies.
Lighthouse Instrument’s FMS analyzer is a robust solid state device and is straightforward to use. Operators do not require special expertise to run the system meaning the accuracy of the measurements does not depend on operator skill.
Lyostat and Lyotherm analyses can be provided on a contract basis – for more information see freeze drying product & process development.