Gea%2b%2bcontrolyo%2bflyer%2benglish%2blr%2br 1 0 tcm30 17484
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GEA Lyophil ControLyo ™ Nucleation On-Demand Technology engineering for a better world ControLyo™ nucleation on-demand technology licensed from Praxair can deliver improved product uniformity, quality, and yield, while reducing cycle times by up to 40%. This proprietary technology can control the nucleation temperature of a solution to within 1ºC of its freezing point, delivering exceptional control to a previously uncontrolled freezing process. Take control of your time, your costs, your product Until now, the freezing step of lyophilization was uncontrolled due to the random nature of the nucleation process. In a typical pharmaceutical lyophilization process, the contents of individual vials nucleate over a broad range of temperatures, usually spanning 5°-20°C below the formulation’s freezing point. Cooperation between Praxair and GEA Lyophil Today, Praxair‘s patent pending process technology implemented on GEA Lyophil’s freeze dryers, offers a novel and scalable method for controlling nucleation of the freezing step in commercial lyophilization without requiring any changes to existing drug formulations. Technology Benefits: Improved product quality • Improves vial-to-vial uniformity • More homogenous cake • Reduces protein aggregation • Aligned with FDA’s QbD initiative Increased lyophilization capacity • Reduces primary drying times by up to 40% • Lowers operating costs • Lowers capital costs Improved product yield • Reduces freeze damage for some APIs • Reduces vial cracking
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Transcript of Gea%2b%2bcontrolyo%2bflyer%2benglish%2blr%2br 1 0 tcm30 17484
GEA Lyophil ControLyo™
Nucleation On-Demand Technology
engineering for a better world
ControLyo™ nucleation on-demand technology licensed from Praxair can deliver improved product uniformity, quality, and yield, while reducing cycle times by up to 40%. This proprietary technology can control the nucleation temperature of a solution to within 1ºC of its freezing point, delivering exceptional control to a previously uncontrolled freezing process.
Take control of your time, your costs, your product
Until now, the freezing step of lyophilization was
uncontrolled due to the random nature of the nucleation
process. In a typical pharmaceutical lyophilization process,
the contents of individual vials nucleate over a broad
range of temperatures, usually spanning 5°-20°C below the
formulation’s freezing point.
Cooperation between Praxair and GEA Lyophil Today, Praxair‘s patent pending process technology
implemented on GEA Lyophil’s freeze dryers, offers a novel
and scalable method for controlling nucleation of the
freezing step in commercial lyophilization without requiring
any changes to existing drug formulations.
Technology Benefits:
Improved product quality
• Improves vial-to-vial uniformity
• More homogenous cake
• Reduces protein aggregation
• Aligned with FDA’s QbD initiative
Increased lyophilization capacity
• Reduces primary drying times by up to 40%
• Lowers operating costs
• Lowers capital costs
Improved product yield
• Reduces freeze damage for some APIs
• Reduces vial cracking
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Nucleation Comparison
Nucleation Temperature Impact on Drying Time
Uncontrolled Nucleation ControLyo™ Technology
Data provided by Praxair
Problems• Very cold nucleation• Widely varying product temp paths
Improvements• Warmer nucleation• More uniform product temp paths
GEA Pharma Systems – Lyophil™
GEA Lyophil GmbHKalscheurener Straße 92, 50354 Hürth, GermanyPhone: +49 (0) 2233 6999 [email protected] www.gea-ps.com
This technology is available for existing and new units
