Continuous Process
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We are changing the way
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OUR APPROACH
We’ve built a solution for inline freeze-drying that greatly reduces
We’ve built a solution for inline freeze-drying that greatly reduces
processing time and increases sterility assurance.
Using a continuous process approach, we’ve achieved a greater than 10X throughput capacity. Processing and filling both occur in a closed, sterile environment which minimizes the possibility of contamination.
ADVANTAGES
ContinuousProduct flows automatically from formulation, drying, and optionally to filling. Process about 1 kg of freeze-dried powder per hour.
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Lower CAPEXOverall costs are less than about 40% of conventional shelf/tray equipment.
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Lower OPEXAbout 40% to 70% less energy used than existing systems. Labor and maintenance are also lower than shelf-type systems.
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Smaller FootprintCombined formulation, processing and filling installation ranges from 20% to 40% smaller production floorspace. System is designed to form an inline work center vs. isolated island or work room.
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Higher QualitySterile, closed system for processing and filling that requires less interaction, which minimizes the possibility of contamination. Result is higher assurance of final product sterility and process consistency. Less wasted product and manufacturing time.
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ReconstitutionConsistency in the shape and final particle size of about 50 to 250 micrometers can result in a more rapid reconstitution for use.
Example: Benchmark tests indicated a time to reconstitute for Mannitol of 15 seconds or less. |
OPERATIONAL FEATURES
Operations managers and production teams can both achieve their targets: increased throughput plus faster access to fully compiled GMP run data.
Initial output in as little as 5 hours from start, depending on formulations. Process condition data is instantaneously available. Self-correcting process adjustments optimize the lyophilization cycle without special machine setups, multiple cycles, wasted ingredients, or relying on complex equations.
1 kg
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Speed of processing is somewhat dependent on the formulation being used, but in general, the freeze-drying process will become shorter in the production critical path.
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Output
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Increases product release rate.
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Control |
If needed, the automated controls for temperature and retention can be adjusted during optimization of process variables.
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FINAL PRODUCT ATTRIBUTES
Sublime lyophilization delivers expected final product metrics.
We’re also helping you create additional possibilities with a few new ones.
Low residual moisture content requirements can be met to assure stability and shelf-life.
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Sublime process is within the industry standard range for bulk density.
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Small particle size versus 'vial cake' greatly increases the surface area available for reconstitution.
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Nearly spherical shape is realized during the initial freeze-drying stage of production. Consistency, ease of product flow, and final esthetics benefit from this process outcome. It’s how we roll.
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