Tempris a Powerful PAT Tool |
Real Time Product Temperature Monitoring with Tempris
The product temperature is the most important critical quality attribute in a freeze drying process. For example, product temperature above the critical formulation temperature during primary drying commonly results in severe damage to the product. The wireless and battery-free Tempris sensors can be applied on all scales of freeze dryers and thereby provide the most comparable and consistent data for this parameter in real time throughout development, transfer and production of a lyophilized product, even in combination with automatic loading systems. Tempris sensors were specifically designed for monitoring and optimization of freeze-drying processes, and have proven their reliability in many industrial and academic applications. Tempris has a variety of advantages over other temperature sensors applied in freeze drying:
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Skill OneTempris was developed for lyophilization in collaboration with leading pharma companies and universities in Europe and the USA.
Tempris sensors used in laboratory scale can also be used in pilot and production freeze-dryers under cGMP guidelines to obtain directly comparable data. Experience the new freedom of wireless, battery-free and real-time measurement of product temperature Tp during the freeze-drying process. As a PAT tool it provides the most important information about Tp in the freeze-drying process and thus amazing opportunities for process optimization and product quality improvement. |
SedSystemSedSystem Includes:
Up to 16 sensors with calibration certificates, external or internal antennae (CIP/SIP), accessories, TDS software, operating manual and installation guide. The measurement data is stored in real-time on the TLAB.transfer unit. The measurement system is mounted with a few simple steps and immediately ready to use. Options: Compliance with GAMP 5 and FDA 21 CFR Part 11, IQ/OQ documentation, engineering support for system adaptation (URS) and installation, training. |
TEmpris Lyophilization
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