Articles and Publications
These articles of and related to Tempris section are a treasure trove of articles that delve into the intricacies of Tempris’ wireless temperature measurement technology for use in the freeze-drying process. These articles provide a deep dive into how the unique, wireless, battery-free, and real-time technology works and how it can be used to measure product temperature during lyophilization. They discuss how this technology can provide valuable data for process optimization and product quality improvement. In addition to articles written by Tempris, there are also articles about Tempris that offer an independent evaluation of the Tempris system. They discusse issues like lyo-cycle process verification, robustness studies and how the Tempris temperature profiles were in excellent agreement to thermocouple data when sensors were placed center bottom in a vial.
PAT Tool for Pharma 4.0
Freeze-drying: Real-time monitoring of product temperature
Hans-Jürgen Bittermann
The article addresses challenges in modern freeze-drying, such as the inability to directly measure product temperature. This limitation leads to longer cycles. However, Tempris, a PAT tool, offers real-time monitoring, ensuring targeted product quality. By accurately determining temperature endpoints, Tempris enhances stability, reduces errors, and enables agile freeze-drying operations. Its wireless, battery-free sensors, based on oscillating quartz technology, integrate seamlessly into existing freeze-dryers. Tempris’s effectiveness is demonstrated in pharmaceutical production, with Pfizer endorsing its robustness in large-scale trials.
Tempris Wireless Temperature Sensors – New Generation
Initial Evaluation Tests
‘Gilyos, February 2024’
This article compares two newly introduced Tempris sensor designs with conventional thermocouples for freeze-drying applications. The wireless temperature sensors are passive, sterilizable, and facilitate real-time monitoring. Testing involved prototypes of the new sensors, the prevailing design, and thin wire thermocouples, all conducted on a Lyostar 3 freeze dryer. The study validates the applicability of the novel Tempris sensor designs for varied freeze-drying scenarios.
Tempris GmbH – Transforming Lyophilization with Innovative Temperature Monitoring
published in ‘Pharma tech outlook, January 2024’
Tempris developed wireless, battery-free sensors for real-time monitoring of temperature during lyophilization process. This technology eliminates manual placement issues and ensures precise temperature assessment, enabling comprehensive traceability and batch-to-batch comparability. It sets a new gold standard for temperature measurement, empowering companies globally while safeguarding batch consistency and regulatory compliance.
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PAT Tool for Pharma 4.0
published in ‘Spinco Biotech CuttingEdge, November 2023’
Tempris is a wireless PAT tool that enables real-time product temperature monitoring during freeze-drying. It complies with industry standards and significantly enhances freeze-drying process control, shortening product time-to-market for pharmaceutical companies and ensuring consistent, high-quality pharmaceutical production.
“Operational Excellence“ in der Arzneimittel-Produktion – In-process control: Funkbasierter Echtzeit-Temperatursensor
published in ‘PharmaTEC publication; 02 March 2022; in German’
Dipl.-Ing. Hans-Jürgen Bittermann
“Pharma 4.0” uses sensors to monitor product quality and optimize processes. Tempris offers a contactless real-time measurement of product temperature in powder granulators, allowing for continuous control of the formulation. Hermes Pharma GmbH uses Tempris for real-time temperature monitoring in powder granulators to achieve operational excellence.
Lyocycle Optimization – “Hot” and “Cold” Spot Determination (HTC) using Tempris for Wireless Real-Time Temperature Measurement as Process Analytical (PAT) Tool
Presenting a Production Scale Performance Qualification Case Study
Performance Qualification (PQ) is vital for modern validation in aseptic lyophilization. PAT tools, like Tempris, monitor and optimize processes across all scales. A case study identified temperature variations in commercial lyophilization. Tempris, a real-time PAT tool, was used to define hot and cold spots (HCS) during PQ, aiding in process optimization.
Continued Process Verification of a Lyoproduct
Conference Paper February 2020; Conference: Freeze-Drying Technology Summit, Vienna, Austria
Dr. Andrea Weiland-Waibel
Critical Quality Attributes are linked to the critical formulation temperature and critical product parameters. Process robustness testing during development is explained and the implementation into the regulatory documents as well as an overview on cpv of the product analysing the lyocycle as well as the critical quality attribute residual moisture is shown.
Wireless Temperature Measurement in Lyo Process Development, Validation and Production
published in ‘Die Pharmazeutische Industrie 81(5):719, Mai 2019’
Dr. Andrea Weiland-Waibel
Wireless temperature measurement during lyo process development, validation and production with the aim to apply process control. This is performed by the determination of product temperature Tp in critical positions (“hot” and “cold” spots). Also it is explained how this approach was implemented into the Common Technical Document (CTD) regulatory submission and that it was successfully approved. How to use the Tp measurement as a key element of the continuous process verification is also demonstrated.