Make your Work Easier
Enhance your laboratory freeze-dryer with cutting edge measurement technology combined with a novel method for determining the endpoint of primary drying.
Your well-designed and robust formulation is the key to achieving in-process and long-term stability of the active pharmaceutical ingredient (API). Tempris provides innovative and reliable solutions to support customers in the pharmaceutical and biopharma industry, aiming to achieve specified quality and maximum efficiency, ultimately reducing costs and ensuring the availability of vital medicines.
Sensor Technology
• Battery-free and wireless real-time transmission
• High accuracy due to quartz crystal
• No heat input into the product
• Suitable for all common types of primary packaging
• Usable in an automated sterile GMP environment
Digital Twin
• Digitalization of sensor measurement positions (HCS)
• Interface for importing process parameters
• 3D product temperature (Tp) and process visualization
• Time stamp comments on the lyo run
• Enhanced process understanding and root cause analysis
Lyo CLC
• Determining the end point of primary drying
• Application of inferential statistics for reliable product outcome
• Statistical evaluation of standard deviation parameters
• Reporting with probabilities
• Reporting with acomparison of lyo run results
Main Benefits
• Achieve correctness by design first-time.
• Lyo CLC software predicts the primary drying end point, reducing safety margins and costs.
• In-process control improves scaling and process transfer, saving time and costs.
• Accelerate drug approval by several months within-process control.
• Advanced sensors ensure reliable data comparability overall scales.
Digital Twin
The digital twin of your freeze-drying system visualizes complex process sequences, enables faster development of solutions, shortens process transfer time, and maintains quality through data analysis. It also helps to scale processes using wireless and battery-free sensor technology or to optimize them for approval processes.
Lyo CLC (Beta Version)
The Tempris technology, in combination with the Lyo CLC software, enables precise compliance with the critical formulation parameters (CFT), such as pressure and product temperature overtime, and for the first time know also the exact calculation of the end point of primary drying in advance, thanks to a specially developed algorithm to determine the heat power transfer into the vial during the end of primary drying.
The following in put signals are supported by the internal modeling and can be displayed with the Tempris software: Pirani, Capacitive Manometer (CM), other temperature sensors such as shelf temperature (TS) and condenser temperature (TC).
Process Development and Process Optimization
The chart illustrates value-adding steps you can take using Tempris technology at all levels of scaling.
According to the report “A Regulatory Perspective on Manufacturing Processes Pertaining to Lyophilized Injectable Products ”by Steve Y. Rhieu, David D. Anderson, and Kumar Janoria, more than half of the deficiencies in regulatory approvals are due to inadequate development of the freeze-drying cycle.
Abandon non-scalable technologies and adopt a forward-thinking solution for your development, delivering greater efficiency and economic benefits right from the start.
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