The importance of product temperature during lyophilization of proteins, microorganisms and other active pharmaceutical ingredients is not in doubt, as it determines the quality of the product as long as the formulation-specific maximum product temperature is not exceeded. The great challenge lies in lyophilization cycle optimization in order to keep the lyophilization process time as short as possible, since even an increase in product temperature by 1°C means a reduction of the primary drying time by approximately 13%.
In order to run the lyophilization process at the highest possible temperature, it is essential to maintain the critical formulation temperature.
Product temperature monitoring during a freeze-drying cycle is traditionally performed using a single-point sensor such as thin wire thermocouples in a lab environment. Variations across freeze dryers as well as the spatial distribution of vials inside a given freeze dryer often result in substantial differences in the vials heat transfer coefficients and temperature profiles. While such differences may be tolerable in laboratory-scale experiments, they can cause considerable complications in production-level machines.
The demand by pharmaceutical manufacturers for a replacement of the thermocuoples usually used is therefore understandable, as these cannot be used in a sterile environment (isolators) and with automatic loading and unloading systems, limiting the use of thermocouples only for non-sterile engineering runs.
Tempris presents its wireless and battery-free sensor, which enables new possibilities in validation and process data monitoring.
Wireless and battery-free operation
Real time data
Sensors for all vial sizes and batch trays
Sterilizable and easy to clean
cGMP, GAMP5 and 21 CFR Part 11 compliant
Sensor calibration on site
Flexible sensor positioning
One technique for all lyo applications
The Tempris technology is applicable on all scales of lyophilizers, even in production units with automatic loading and unloading systems, and thereby allows comparison of consistent product temperature profiles over the scale-up and transfer process. A process developed in laboratory scale can be directly correlated to subsequent pilot scale batches used for clinical supply, up to validation and routine batches in manufacturing scale equipment. This way, Tempris sensors supply data for the most important critical quality attribute, product temperature, throughout the product life cycle with the identical measurement technology. In addition, the product temperature profiles allow early detection of equipment-related differences between lyophilizers, including extension of freezing and primary drying times which require compensation. This way, process conditions can be more easily adapted to achieve acceptable product with a high degree of assurance in product quality.