Tempris – An Overview

Based in Holzkirchen, Bavaria, Tempris GmbH is rapidly establishing itself as an innovation leader in real time temperature measurement and monitoring in lyophilization. This is due to its development of unique wireless and battery-free quartz-based sensors of unparalleled accuracy and reliability that enable real-time monitoring in vials, dual-syringe systems, and bulk materials during the whole freeze-drying process.

Collaborating with leading names in the industry, Tempris sensors are revolutionizing process control in biotechnological and pharmaceutical lyophilization/freeze-drying, where measurement of actual product temperature is pivotal in ensuring pharmaceutical product quality. Tempris is working with leading partners to apply this technological advance to unlock full automation and major productivity gains in lyophilization processes.

Easify Your Process

Tempris wireless and battery-free product temperature sensors change the conventional narrative for process control, putting an end to the problem of ‘flying blind.’ In lyophilization monitoring, with little data on actual product temperature during the lyophilization process.

The Tempris brand strapline: ‘Easify your Lyo Process’ encapsulates its mission to automate and optimize freeze-drying processes by enabling real-time product temperature monitoring while freeze drying is in progress in the lyophilization chamber.

The company’s vision is to extend this real-time data connectivity with products to extend Pharma 4.0 ‘smart factory’ functionality, robotics, and digital integration into challenging pharma processes such as lyophilization.

Products & Services

Tempris is a Process Analytical Technology (PAT) tool that streamlines lyophilization processes by providing real-time, accurate, and reliable temperature data. One of the fundamental advantages of the technology is the same sensors can be used at every process stage of lyophilization from laboratory development through to full scale industrial process.

Tempris has developed four main product and service streams:

• Development & Manufacturing of a real-time product temperature measurement system using wireless and battery-free sensors that enable real-time product temperature measurement in the laboratory and production. Tempris quartz-based sensors are specifically designed for monitoring product temperature and optimizing freeze-drying processes and have already proven their reliability in many industrial and academic applications.
• Process Control: Application of Tempris technology as a PAT tool for monitoring product temperature and process control in freeze-drying. The Tempris technology harmonizes with the FDA’s Process Analytical Technology (PAT) initiative designed to expedite drug approvals via in-process monitoring and streamline process transfers to new freeze-drying facilities. This transformation presents significant time and cost advantages and also a shorter time to market compared to traditional approval methods, creating new prospects for the industry.
• Software: Development of TLM Tempris Lyophilization Monitoring Software as a software platform that interfaces with the Tempris TIRU3 interrogation unit to record data, set all parameters, and visualize and export data.
• Implementation: Tempris supports its end users with qualified installation, system qualification, training, and technical assistance, including system maintenance and calibration.

Connected with these product focus areas are activities such as development of automated loading and placing of sensors. Tempris is collaborating with partners such as HOF Sonderanlagenbau, Merck International, Pfizer, and robotic specialist Stäubli to devise automated solutions for the computer-controlled insertion of sterile sensors. This single improvement could improve the efficiency and precision of pharmaceutical manufacturing to release an estimated overall 20% time and cost reduction through Continuous Process Verification (CPV). This automation solution is compliant with Annex 1 aseptic process regulations while also facilitating streamlined reporting, enhancing product quality, and protecting patient safety.

Origins

Tempris was originally founded as iQ-mobil in 2002 to develop Anton Mangold’s invention of a wireless and battery-free sensor to measure tire pressures in Formula 1 and NASCAR motor racing. After some years, it was recognized that the same basic technology of quartz-based sensors could also be applied to process temperature measurement, particularly in the extremes of lyophilization/freeze-drying.  From 2019, the renamed Tempris company began developing and marketing a second-generation sensor adapted to robotic placement.

From its headquarters south of Munich, Tempris has added distribution partners in Europe, Asia and the USA.

The company is certified under the ISO 9001 international standard for quality management systems, as well as ISO 14001 for environmental management and sustainability, with all products designed and engineered to comply with applicable regulations, and continually improve their environmental performance, such as Good Automated Manufacturing Practice (GAMP 5) guidelines and FDA 21 CFR Part 11 / EU GMP Annex 11 for compliance of IT systems and electronic records.

Resources

Click on Tempris – Product Temperature Measurement in Lyophilization for further information.
Click on Tempris Sensor Technology  to watch video.