In the life sciences industry, performing regular, traceable calibrations on process instrumentation is necessary to maintain the accuracy and reliability of process measurements, whilst complying with all necessary legislative and regulatory requirements.
However, calibrations can be costly and usually result in process downtime, with a corresponding impact on manufacturing. Failure to calibrate at the correct intervals can result in errors that affect product quality or safety, with potentially major cost implications. To help end users overcome such issues, Endress+Hauser has introduced flowmeters with Heartbeat, an on-board verification technology offering a real alternative to calibration in regulated industries or any other industry in which regular calibration is required.
Whilst there are many instruments on the market today with self-diagnostic features that give the user some level of information about the health of the device, most of them fail to provide traceable evidence that the instrument is still operating in accordance to the original manufacturer’s specification. Heartbeat Technology overcomes this by providing a continuous healthcheck of the flowmeter, ensuring key device parameters remain within Endress+Hauser’s original specification. Any deviation from factory reference values will be displayed in easy-to-understand diagnostic data, highlighting that maintenance is required or a failure has occurred, in accordance with NAMUR NE 107 and NE 44.
Maintenance programmes Regulatory bodies and standards, including GMP and ISO 9001, define the need for process instrumentation to be periodically calibrated or verified against measurement standards that are traceable to national or international standards; it is the end user’s responsibility to determine the correct frequency for calibrating each and every process instrument. The decision on when to calibrate a device can be difficult, requiring the end user to find the right balance between saving operational costs (by extending intervals between calibrations) and ensuring the reliability of the process. The aim is always to minimise downtime whilst maximising plant productivity. To date, if an end user decided to extend the period between calibration cycles, they had to do so in the knowledge that the condition of the device in between calibrations could not be easily verified.
Embedded verification An alternative way to fulfil legislative requirements and massively increase confidence in the installed flowmeters is through on-board verification of the device. The device runs an independently verified on-board diagnostics program where all relevant components of the instrument are checked. This allows the user to confirm and document that the instrument still conforms to the original factory reference values. Verification of an instrument equipped with this self-diagnostic capability can be performed without removing the instrument from the process, therefore reducing the potential for process contamination and the risk of damage to the device during the reinstallation process. It may not even be required to interrupt the process as the verification tests can all be performed in the background. Pass or fail results are available immediately after the test, providing the user with clear information on whether the instrument is still operating according to specification.
Independent validation TÜV, an internationally respected certification body, has independently validated Endress+Hauser’s Heartbeat Technology and has concluded that the result of this on-board verification technology is every bit as valuable as a wet calibration. Utilising devices with Heartbeat allows users to significantly extend calibration cycles, reducing operating expenditure whilst ensuring the process remains fully compliant.
A key benefit of Heartbeat verification is that it can be initiated locally or remotely with minimal effort. The procedure is usually completed within a few minutes, which means that the verification can be easily performed on a daily or batch-by-batch basis, significantly increasing the confidence in the flowmeter and its ability to precisely measure necessary components. Following a Heartbeat verification, the device generates a report that can be downloaded in PDF format for storing or archiving, with the last eight verifications stored inside the flowmeter transmitter.
Verification report
The verification report is generated directly in the flowmeter and provided as a tamper-proof PDF file. The file can be accessed directly via a web server or downloaded remotely through a DCS or asset management control system.
For more information please email sales@uk.endress.com or call us on 0161 286 5050