Tempris Downloads

(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).

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)

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)