• • • ENVIRONMENTAL MONITORING • • •
The advantages of digital sensors within an environmental monitoring system
Environmental parameters are critical to product quality and as such are controlled and monitored within the pharmaceutical industry, says James Pickering, director of environmental monitoring systems at Rotronic
W
hen certain products are exposed to incorrect temperatures or relative humidity levels the product quality is no
longer guaranteed. In the pharmaceutical, cosmeceutical and food industry, this is even more important as consumers’ lives can be put at risk due to environmental effects on the products/ingredients such as decomposition, diminished effects/taste, and spoilage. In the pharmaceutical industry, regulations have
been put in place to protect the patients and to deliver quality-assured, safe, and effective products. The temperature range, along with other parameters, to ensure product quality is defined during the product risk assessment. When a facility is designed, an integral part of
the design is the building management system (BMS). The BMS manages many services within a facility including the heating, ventilation, and air conditioning (HVAC) of a building with the help of sensors located throughout the facilities. In order to ensure that the BMS is controlling
the HVAC system correctly, an environmental monitoring system (EMS) can be installed. The EMS will monitor all the critical control parameters defined during the product risk assessment at critical locations defined during the facility qualification. The GxP quality guidelines, developed by the
regulatory authorities, are designed to cover the product quality over the complete life cycle of the product. The GxP guidelines state that the area used
must be qualified, the temperature should be monitored, and monitoring devices must be calibrated to meet the guidelines.
What is a digital sensor? A digital sensor is a measurement device that sends out a digital signal. The main advantage of a digital sensor compared to an analogue sensor is the information sent. Whereas the analogue sensor will only send an mA or voltage value (that is converted into a measurement value), a digital sensor can send much more data such as:
• Measurement value(s); • Device serial number; • Device status; • Calibration data; and • Adjustment data.
The Rotronic digital sensors all have onboard memory and can be user-calibrated/adjusted.
The main advantages of using digital sensors within an EMS? The Rotronic digital sensors communicate to data loggers (wired or wireless) and all communication to the server and database is done digitally as such there is no loss in accuracy during data transmission. This means, unlike analogue sensors, no loop check is required during device installation and qualification/validation. A major advantage of using digital sensors
within an EMS is the possibility to use the additional data and reduce the amount of downtime, this is especially valid during the calibration period or during service periods. With analogue sensors, a calibration can be
done either in a calibration laboratory (internal or external) or in situ if the application permits. If the
calibration is carried out in situ, then then the loop check is also done at the same time. For calibrations carried out in a laboratory, the device needs to be dismounted (leading to system downtime).
How does the RMS allow for
third-party device integration? Rotronic offers a few environmental parameters. However, within the pharmaceutical industry, other parameters also require monitoring. Another parameter that is also measured within cleanrooms is particle monitoring. Rotronic has developed a tool, the RMS-CONVERTER-100 to import third-party devices via their MODBUS TCP communication interface.
What is the PST Calibration
Portfolio? Michell Instruments and Rotronic, both part of the Process Sensing Technology (PST) Group, and market leaders in the field of humidity and trace moisture measurements, offer a full range of temperature and humidity calibration equipment and systems. These include transportable humidity
generators for simple verification of relative humidity and temperature probes, pressure swing dryers and low dew-point generators for calibrating trace moisture sensors and instruments. As well as building custom-designed humidity and dew- point calibration systems, we also provide ISO/IEC 17025 accredited relative humidity and temperature calibrations in six locations around the world.
20 ELECTRICAL ENGINEERING • NOVEMBER 2021
electricalengineeringmagazine.co.uk
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