New Generation: Digital High-End Temperature Sensor Rotronic RMS TCD-S-001

The digital sensors from Rotronic communicate with data loggers (wired or wireless), and all communication with the server and database is digital, ensuring there are no accuracy losses during data transmission. This means that, unlike analog sensors, no communication line verification is required during installation and device validation.

The new addition to the range is the digital high-end temperature sensor RMS TCD-S-001. Its major advantage is that it can be replaced, for example for calibrations, almost without downtime and without measurement interruption. Calibration and adjustment data are always stored securely on the sensor, and when replacing a sensor in the RMS Monitoring System, the new serial number is automatically recorded in the "Change Control."

Highlights:

– Excellent accuracy (±0.25 °C from -50 to 85 °C), reproducibility, and long-term stability (±0.5 °C/year)
– Compatible with RMS data loggers and RMS software
– Low power consumption
– Digital communication (Modbus RTU)
– Hot-swap capability ensures minimal or no downtime
– Automatic serial number replacement is documented in the RMS audit trail
– Monitoring compliant with GxP and FDA 21 CFR Part 11

What are the main advantages of using digital sensors in an EMS?

The digital sensors from Rotronic communicate with data loggers (wired or wireless), and all communication with the server and database is digital, so no accuracy losses occur during data transfer. This means that, unlike analog sensors, no loop check is necessary during installation and qualification/validation of the device.

A major advantage of using digital sensors in an EMS is the ability to utilize additional data and reduce downtime, especially during calibration phases or maintenance periods.

With analog sensors, calibration can be performed either in a calibration laboratory (internal or external) or on-site if the application permits. On-site calibration also includes loop testing. For laboratory calibration, the device must be removed from the system (causing a system shutdown). With Rotronic's digital sensors, a simple hot-swap can be performed that causes no downtime:

– Manual unscrewing of the existing sensor.
– Manual screwing in of a "new" pre-calibrated sensor.

The existing sensor can then be calibrated in a laboratory and either reinstalled at its original location or used elsewhere in the system. Another advantage is that RMS, thanks to the digital system and the requirements of FDA CFR 21 Part 11/EU Annex 11, automatically indicates when a sensor has been replaced, along with the audit trail showing the time, date, and serial number of the sensor before and after replacement.

Rotronic Monitoring System RMS

The new digital temperature sensor RMS TCD-S-001 complements the hardware range of the Rotronic Monitoring System (RMS). RMS is a GAMP©5 category 4 software combined with category 1 hardware, helping users monitor their GxP-compliant applications, verify critical quality attributes, and oversee critical process parameters. This allows you to focus on patient safety, product quality, and data integrity while ensuring compliance with EudraLex EU Annex 11 and FDA CFR 21 Part 11. Rotronic AG develops and manufactures RMS hardware and software based on GAMP©5 guidelines.