Tempris for
product-centric lyophilization
Tempris for Lyophilization
From Real Product Data to Better Lyophilization Decisions
Tempris makes the actual thermal response of the product visible inside the vial and connects it with spatial process context, physical models, and expert methodology.
This provides a reliable basis for understanding, scaling, transferring, and improving lyophilization processes – from laboratory development and engineering runs to PPQ, GMP production, and CPV.
How Does Process Knowledge Create Sustainable Business Value?
Every lyophilization run generates data. But data create value only when the insight from the current run improves the next industrial decision.
The Tempris Perspective explains why the economic value of a pharmaceutical product is shaped not only by drug innovation, but also by the quality of its industrial process development, scale-up, transfer and manufacturing.
From Experiment to Industrially Applicable Process Intelligence
More data does not automatically yield more process knowledge.
Product-temperature data become industrially useful when they are representative, spatially and temporally contextualized, physically interpretable, and comparable across runs, equipment, and scales.
Tempris connects four clearly defined layers:
Two Connected Pathways — One Product-Centric Approach
LyoCONNECT
Make Real Product Behavior Visible
LyoCONNECT wirelessly measures and structures real-time product-temperature data directly inside the vial.
By linking product temperature with sensor identity, vial position, shelf, process parameters, and equipment conditions, LyoCONNECT creates a representative product-data foundation from development through engineering runs to GMP production.
Use LyoCONNECT when you need to:
- make actual product behavior visible rather than relying on equipment signals alone;
- identify critical vial positions, hot and cold spots and thermal variability;
- compare product-temperature profiles across runs, scales or equipment;
- create a reliable data basis for development, transfer, PPQ and CPV.
LyoINSIGHT powered by LyoCLC®
From Product Data to a Technically Justified Next Step
Every lyophilization challenge begins differently: a cycle is too long, a laboratory cycle must be scaled, a transfer to another site or CDMO is planned, or a production batch shows defects.
LyoINSIGHT helps structure the question, identify the data that matter, and define the technically appropriate next step.
Tempris combines representative LyoCONNECT measurement, Digital Twin context, and LyoCLC® analysis with expert consulting. Depending on the project objective, this can support:
- endpoint assessment;
- Kv and Rp interpretation;
- evaluation of positional and process variability;
- model-based residual-moisture estimation as an additional endpoint parameter;
- Design Space scenarios;
- cycle optimization;
- scale-up and technology transfer;
- engineering runs, PPQ and CPV.
The result is not another isolated data set, but a project-specific pathway toward process understanding, product quality and an appropriate cycle time.
Why Tempris?
For more than 20 years, Tempris has supported pharmaceutical development, MSAT, engineering, and manufacturing teams in measuring actual product temperature directly inside the vial.
The decisive advantage is not measurement alone. The same product-centered measurement principle can be applied across different process phases – from laboratory development through engineering runs to GMP production.
This creates comparability between runs, equipment and scales and provides a reliable basis for reusable process knowledge.
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.