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.

Dipl.-Ing. Hans-Jürgen Bittermann
„Operational Excellence“ in der Arzneimittel-Produktion – In-process control: Funkbasierter Echtzeit-Temperatursensor

(PharmaTEC publication; 02 March 2022; in German)

“You can’t manage what you can’t measure” – quote from the management mastermind Peter F. Drucker.

Digitalisation in pharmaceutical production (“Pharma 4.0”) means above all equipping and networking production facilities with sensors to monitor product quality and optimise processes.

As a PAT tool, Tempris offers a solution for contactless real-time measurement of the product temperature in powder granulators during rotation in the product without interrupting the granulation process – and thus continuous control of the formulation.

Read this article to find out how Hermes Pharma GmbH uses the wireless and battery-free Tempris PAT tool for real-time temperature monitoring in powder granulators to achieve operational excellence (OPEX).

Dr. Andrea Weiland-Waibel
Continued Process Verification of a Lyoproduct

Abstract
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.

(Conference Paper February 2020; Conference: Freeze-Drying Technology Summit, Vienna, Austria)

Dr. Andrea Weiland-Waibel
Wireless Temperature Measurement in Lyo Process Development, Validation and Production

Abstract
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.

(May 2019; Die Pharmazeutische Industrie 81(5):719)