The Lyostar3 operates a cutting edge R&D system, moving users away from the ‘trial-and-error’ elements during the development processes, toward unique SMART technology that enables fast and easy optimisation of cycles, and ensure the smooth transfer from laboratory- to production-scale.
Independent studies have confirmed the use of SMART Freeze Drying Technology™ software from SP Scientific (available with the Lyostar), has offered a time reduction on an average cycle development in the order of 78%. The technology reduces the average cycle development to one or two runs, rather than the conventional series of six to eight runs – thereby not only reducing development time, but also lowering materials costs by at least one third.
Difficulties involved within the freezing parameter of the overall process is a stage that many agree remains the only portion of freeze drying that is largely uncontrolled due to ice nucleation. This is because ice nucleation is generally a stochastic process, so the degree of super-cooling varies both inter and intra-batch.
To combat this, the Lyostar3, utilises Praxair Control-Lyo Nucleation technology with its sudden decrease in pressure that causes each vial to nucleate at the same time; this is very important when considering batch to batch reproducibility.
Another technique at the forefront of freeze drying science is TDLAS (Tunable Diode Laser Absorption Spectroscopy), that enhances process performance understanding using non-intrusive measures, such as water vapour presence, flow velocity, & water mass flow (dm/dt) measurements – this too is available with the Lyostar3.
Therefore, given its adaptability to a range of contemporary tools for monitoring pharmaceutical freeze drying, R&D scientists have made the Lyostar3 their preferred developmental freeze dryer, to ensure the capture of these critical data-sets.
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>>Pages 62-63 – Article as featured in IPI Magazine (Spring 17) on ‘Controlled Nucleation utilising ControLyo™ & SMART technology enables streamlining of your product and cycle development processes.‘