Lyostat Freeze Drying Microscope by Biopharma Process Systems

Lyostat Freeze Drying Microscope enables identification of 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 and solute structure. This information is vital for formulation and cycle development, scaling up to production, regulatory submissions and quality control.

Uniquely, as well as instructing correct use of the equipment, our training provides practical tuition on interpretation of results from scientists with practical knowledge of freeze drying and of using Lyostat for R&D.

Lyostat is supplied fully validated as a complete working system against a series of standard solutions. Full installation and training is offered as standard. Installation and operation qualification (IQ/OQ) packages are also available, and can be customised to bespoke specifications if required. The software is also available in a 21CFR11 compliant version.