LyoStat 5 Freeze Drying Microscope

Lyostat 5 from Biopharma Technology Ltd (BTL) is an advanced freeze drying microscope, with PC control for image and data capture and analysis functions.Freeze drying microscopy (FDM) was established in the 1960s as a technique for identifying critical formulation parameters and is the only method for reliably determining collapse temperatures. Historically FDM was used only for collapse / eutectic temperatures but the latest generation FDM can also enables identification of crystallization phenomena, the potential for skin/crust formation, and the effects of annealing on ice crystal growth and solute structure.

Lyostat 5 analysis uses just 2µl and is typically complete in under an hour. Lyostat 5 is supplied fully validated as a complete working system against a series of standard solutions . Lyostat 5 is PC controlled to provide sophisticated image and data capture and analysis functions, which also allows the user to make a video of their sample under analysis. The software is also available in a 21CFR11 compliant version.

BTL has expertise in the formulation of products, accounting for the lyophilisation(freeze drying) steps involved in the development and/or production process. To date BTL has worked with over 1800 products, from small molecules to proteins, organisms, whole cells , collagen products, blood and archaeological samples.

  • Real-time image, sample temperature and chamber pressure displayed on screen
  • Data archiving and profile plotting capability
  • Uses just 1 to 2µL sample
  • LED light source for 60,000 hours of illumination
  • Enables rapid observation of collapse, melting and eutectic event temperatures
  • ‘Image Gallery’ enabling comparisons of stored image sequences
  • High resolution camera provides sharp, clear visualization
  • Motorized vacuum control option, to enable specification of exact pressure
  • Pre-delivery testing includes validation of complete working system against a published series of standard solutions
  • IQ/OQ, service, maintenance and requalification packages
  • Over 1800 different formulations studied so far!
What the Technique / Instrument Is:

Thermal Analysis by Surface Characterisation (TASC) is a software addition to the Lyostat 5 that is used to analyse data files generated by the LINK software post-analysis. It is suited to the high resolution (2.3MP) of the PointGrey colour camera and to the fixed and reproducible focus on the Lyostat 5 imaging station.

How It Works:

TASC analyses incremental changes to successive images in the focus area by the brightness and colour of each pixel, to produce a normalised TASC trace overlay to the data graph. It then looks at changes in the selected area and shows a change in the line based on the degree of collapse. If the collapse temperature is roughly known (by visual inspection of the data file) TASC can then pinpoint the start of this collapse in this region.

Benefits:
  • Accurate and quantitative analysis
  • Reduces operator error in the analysis of the precise collapse temperature
  • Can retrofit to previous results to check validity
  • Flexible analysis useful for many other application outside of freeze drying using the Lyostat 5 – online resources available for more information
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