In order to ensure successful freeze drying, thorough analysis of the product must be carried out pre and post lyophilisation. Information about the characteristics of the wet and frozen product is vital for formulation and process design, while studies on the final dried product ensure stability, activity and shelf life.
Freeze Drying Microscopy
Freeze drying microscopy is an established technique for identifying key temperatures such as melting, freezing and collapse temperature. The Lyostat freeze drying microscope from BTL is PC controlled to provide sophisticated image and data capture and analysis functions. Lyostat also provides information on other important events, such as crystallisation, skin/crust formation and the effects of annealing on ice crystal formation.
Frozen State Analysis
Lyotherm is a thermal and impedance analysis instrument unique to us. Lyotherm analysis provides information about the behaviour of your formulation in the frozen state, identifying changes in molecular mobility such as glass transitions and eutectic melting and giving an indication of thermal events such as crystallisation. This information is vital to ensure that your formulation is not undergoing any adverse changes during the freeze drying process.
Headspace Pressure / Moisture Analysis
Frequency Modulated Spectroscopy (FMS) is a non-destructive gas analysis technique that provides information about residual moisture content and pressure within a sealed container (vial) post-freeze drying. Residual moisture content is an important indicator of the success of a batch and is used to validate cycles or help with formulation and cycle development. FMS also allows changes in residual moisture content and pressure within vials to be monitored over time for long-term stability studies and end-of-shelf life determination. FMS is invaluable for product and process development and quality control.
All of these systems are used in our own on-site freeze drying laboratory, and analyses or trials can be provided on a contract basis – for more information see freeze drying product & process development.