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Unique in the world of

Unique in the world of temperature measuring technology Authors: Giovanni Colucci, Marketing Manager for Temperature, Endress+Hauser Group, Germany, Philipp Garbers, Sector Manager for Life Sciences, Endress+Hauser Group, Germany AUTOMATION Smooth-running processes are essential for high process reliability and system availability in countless industries. In this article, we will provide an overview of a new self-calibrating temperature sensor, which will revolutionize the world of temperature measurement technology. This innovative technology will enable a rethink within the life sciences industry which will reduce costs, modernize workflows and significantly increase process reliability. Measuring devices in the Life Sciences and Food & Beverage industries often require pluri-annual calibrations. Removing and reinstalling probes is a time-consuming and costly step, especially in large plants. TrustSens is the world’s first sensor capable of selfcalibration, making process disruption a thing of the past. Fully traceable, cyclical and during the active process, reducing the risk of undetected nonconformities to a minimum. Now, Endress+Hauser is launching the iTherm TrustSens TM37x. Specially developed for hygienic and aseptic applications, the thermometer enables seamless and traceable calibration in the ongoing process. Full automation makes very short calibration cycles without additional costs possible, which reduces the risk of unknown measured errors to a minimum (self-calibration before every batch). Plant downtimes will also drop significantly. The result is more output with simultaneously less effort, reduced costs and minimized risk thanks to seamless process verification. Physical principle of the sensor At the heart of the temperature probe is a highly developed sensor unit consisting of a primary Pt100 temperature sensor and a highly accurate integrated reference. It uses a physical fixed point on the basis of the Curie temperature and therefore serves to regularly The iTherm TrustSens will represent an essential component of our concepts for calibration optimization. Simone Erath, Marketing Manager for Services, Endress+Hauser, Germany calibrate the primary sensor. That means every time the process temperature drops below 118 °C / 239 °F (Curie point of reference), the reference triggers the recalibration of the primary sensor. Manual intervention is only necessary when the TrustSens sensor reports a malfunction. This ensures that the constantly high measuring accuracy of the temperature sensor is achieved throughout its entire service life. After self-calibrating, the iTherm TrustSens supplies audit-compliant calibration data for complete documentation. A valid calibration certificate can be prepared at any time with a simple mouse click (for example with the Endress+Hauser FieldCare software). 22 WORLD OF INDUSTRIES 2018

Importance for the life sciences industry The self-calibrating TrustSens technology is a major innovation in the regulated GMP environment. However, innovations also raise questions about change management since we currently work with established SOPs and validated processes. TrustSens sensors have fully automated self-calibration or they can be used as a classic temperature sensor and re-calibrated manually. In the long term, both mean a significant increase in process reliability through self-calibration for every steam sterilization above 118 °C before every batch. View into the future The fact that the integrated reference no longer needs to be sent in paves the way for a future in which trusting the measurement technology used and the manufacturer is still of key importance. The new TrustSens technology will enable new workflows and SOPs The self-calibrating thermometer is also designed for installation in small pipe nominal diameters Contiguous process verification is already recommended in the Good Manufacturing Practice regulations (GMP – Annex 15). Full traceability The Sensor is supplied ex-works with a calibration certificate for the fixed-point reference integrated in the sensor. The DAkkS- accredited calibration laboratory of Endress+Hauser thus ensures full traceability of the calibration chain to the ITS-90 International Temperature Scale. Years of extensive load tests over many thousands of calibration cycles, both in the lab and with the customer under GMP conditions have confirmed that the solution is well developed. Long device and process history at any time The integrated smart electronics contain varied diagnostic functions, which are categorized in accordance with the NE107 Namur recommendation and transmitted via Hart communication. Furthermore, status signals are displayed locally by means of the LED integrated in the device. In addition to the automated calibration, and therefore verification of the thermometer’s measuring accuracy, data from the last 350 calibrations is stored directly in the device. This makes it possible to access a long device and process history at any time, which can be used as a basis for the early determination of trends. These functions, known as “Heartbeat Technology”, guarantee continuous, fully autonomous device self-diagnostics. Meet the highest international standards The thermometer for sterile applications is made from high-grade SS 316L/1.4435 stainless steel. The device is available in various surface qualities and can be configured with electropolishing as standard for particularly low germ adhesion. In addition to the current standard approvals for use in professional hygiene applications, the iTherm TrustSens TM37x has been developed and designed fully in accordance with ASME BPE and thus meets the highest international standards. The innovations behind the iTherm TrustSens are the result of around 10 years of research and development along with close cooperation with the customers and partners from the life sciences and food industries. as well as reducing the load on staff in the long term. Against this background, the risk analysis may also receive new impetus in the future. Endress+Hauser is happy to assist you in this transition as part of your change management process so that you can continue to be audit-compliant in the future using the best technology. Photographs: Endress+Hauser, Nordmark Highlights: short-and-sweet summary n Maximized process safety through self-calibration and Heartbeat Technology n No production downtime due to fully automated and traceable inline self-calibration n Fully automated documentation - audit-proof n Highest measuring accuracy through characteristic adjustment n International certifications and approvals To be able to put a great innovation through its paces before market launch – now that’s what creates trust. Dr. Christian Groth, Technical manager, Nordmark Arzneimittel GmbH & Co. KG, Germany n Measuring range: - 40 to + 160 °C (- 40 to + 320 °F) n More than 50 hygienic process connections as standard for industry applications: Life Sciences, Food & Beverage WORLD OF INDUSTRIES 2018 23