Tempris for
product-centric lyophilization
Tempris for Lyophilization
Product-Level Visibility and Product-Centric Process Intelligence
From Data Connection to Process Intelligence
Tempris enables true product-level visibility in lyophilization by wirelessly and continuously connecting real-time vial-level temperature data with process and freeze-dryer context. At the core of this approach is LyoCONNECT, which creates a unified, product-centric data layer from development through engineering runs to GMP production. By linking product temperature to sensor identity, vial position, process parameters, and equipment conditions, LyoCONNECT establishes a robust digital twin foundation for both product and equipment levels.
Building on this LyoCONNECT data foundation, LyoINSIGHT powered by LyoCLC® transforms raw data into actionable process intelligence. Within the digital twin environment, LyoINSIGHT enables advanced interpretation to support endpoint determination, cycle optimization, scale-up, technology transfer, continued process verification (CPV), and deviation assessment.
From Equipment Parameters to True Product Understanding
Traditional lyophilization monitoring relies on equipment-based parameters such as shelf temperature, chamber pressure, Pirani and capacitance manometer readings, and recipe steps. While essential, these signals primarily describe the behavior of the freeze dryer – not the actual conditions experienced by the product in each vial.
Tempris closes this critical gap by directly measuring and contextualizing product temperature at the vial level. This integration of product and process data provides a comprehensive, data-driven understanding of lyophilization, enabling more informed decisions and improved process control.
LyoCONNECT
The Product Data Layer for Lyophilization
LyoCONNECT captures and connects real-time product temperature data at the vial level, including sensor ID, measurement position, process data, and visualization.
This provides transparency into actual product behavior – from research and development through engineering runs to technology transfer.
LyoINSIGHT powered by LyoCLC®
Process Intelligence from Product Data and Digital Twin Context
LyoINSIGHT interprets LyoCONNECT data within the digital twin, including API, formulation, vial type, fill volume, sensor position, load configuration, freeze-dryer characteristics, CPPs, and CQAs.
It supports endpoint assessment, residual moisture interpretation, safety margin review, cycle optimization, scale-up, transfer comparison, CPV, and deviation support.
Why Tempris?
Tempris specializes in wireless in-process product temperature measurement for pharmaceutical freeze-drying.
For more than 20 years, Tempris has supported development, MSAT, engineering, and production teams in understanding, scaling, and transferring lyophilization processes from a product-centric perspective.
The decisive advantage: the same measurement principle can be applied across different process phases – from lab and development through engineering runs to GMP production.
This creates comparability, reduces interpretation gaps and strengthens the data basis for robust process decisions.
Pharma and biotech companies use Tempris to:
The Result:
For pharma and biotech companies, this means less process uncertainty, greater confidence in transfers, and better use of available lyophilization capacity.
Tempris Testimonials
Pfizer’s Experience with Tempris
„Tempris wireless sensors allow placement of temperature sensors in any location within a freeze-dryer. They are also the sensor of choice if product temperatures of edge vials are monitored. Tempris sensors do not release heat while thermocouples or data loggers can transfer some heat into the product (very notable for edge vials), obscuring the actual product temperature. It is especially important if small fill volumes are used as readings of thermocouples and data loggers from the edge vials produce uncertain temperature profiles.”
Want to Make Better Use of Your Lyophilization Data?
Begin with a non-binding expert discussion
Together with Tempris specialists, you can clarify how LyoCONNECT can generate representative product temperature data, which product, vial, process, and equipment data should be included in the digital twin, and how LyoINSIGHT can derive a structured process evaluation from this connected data foundation.
Typical starting points include endpoint assessment, residual moisture interpretation, safety margin review, cycle optimization, scale-up, technology transfer, CPV or deviation assessment.