Compliant GMP calibration with Heartbeat Verification
Built-in verification for optimized calibration and cGMP compliance in life sciences
Calibration program intervals depend on process criticality and the long-term stability of measurement instrumentation. When it's time for calibration, process interruption is inevitable and seals must be broken to apply a calibration fluid to the instrument. The latest generation of mass flowmeters are so reliable that calibration cycles of two years or longer are possible. However, with extended intervals comes an increased risk of a random failure going undetected in the meantime.
20%
only 20% of instruments are set up with an ideal calibration interval
How we can help
Inbuilt verification technology such as Heartbeat Technology by Endress+Hauser provides security between each calibration program and can even be used in strictly regulated industries according to certification by TÜV. The increased availability and measuring point reliability that Heartbeat Technology offers are just two of the many benefits driving life sciences industry users to optimize their calibration procedures. Combining wet calibrations with Heartbeat Verification helps you to:
Decrease calibration frequency and increase intervals between wet calibrations
Increase confidence in your measurements between wet calibrations
Fulfil the traceability requirements according to ISO 9001 - third-party certified
Ensure measurement accuracy without process interruption
Applications
Combining wet calibration with Heartbeat Verification
Tested and independently certified by TÜV, Heartbeat Verification fulfils all requirements specified by DIN EN ISO3 and can be used interchangeably with traditional wet calibration for traceable instrument checks. Reliability is increased, and uncertainties between calibrations are significantly reduced. In contrast to wet calibration, Heartbeat Verification does not use a primary fluid but relies on redundant internal references to verify the device functionality.
Our expertise in the field
A baseline of values is established during the original factory calibration and permanently stored both in the non-volatile, secure memory of the flowmeter, and on file at the factory. When Heartbeat Verification is performed on site the test data is compared with this baseline to detect any electronic component drift or mechanical deterioration of the instrument. Critical electronic circuits are implemented redundantly allowing the detection of hardware failures.
In comparison to wet calibration, integrated verification functions in measuring devices such as Promass 100/300/500 Coriolis flowmeters lead to a time saving of at least 80% and extended calibration cycles.
Extend calibration cycles with Heartbeat Technology
Instruments with Heartbeat Technology deliver consistent and reliable measuring values for years and years of operation. Calibration frequency can in many cases be significantly reduced without jeopardizing regulatory compliance. Fewer wet calibrations reduce the expenses for the calibration program which lead to a better overall equipment effectiveness (OEE) as it increases plant availability.
Our expertise in the field
Less downtime for instrument calibration and fewer unexpected shutdowns will improve operations efficiency and operational excellence. Reliable data, and certified proof that the measured process value is correct, reduce the risk for product quality issues and therefore supports the goal of reaching highest possible patient safety.
Micropilot FMR63B can extend calibration cycles by means of Heartbeat Technology with Radar Accuracy Index, which allows the radar accuracy of the device to be verifies without process interruption.
The iTHERM TM371 represents the world’s first RTD sensor capable of fully automated in-situ self-calibration. The patented innovation has been extensively tested and verified in lab and field trials. Read more in our white paper.
Heartbeat Verification is simple. The instrument does not need to be taken out of service, nor the process stopped. The instrument will continue to deliver measuring results throughout. Taking around 30 seconds Heartbeat Verification is also fast. It can be started remotely from the safety of the control room, and flexibly, for example on a daily basis or before a batch. A full Heartbeat Verification report is generated internally in the device every time a device verification is performed.
Our expertise in the field
This report comes in a tamper-proof PDF format and is easily accessible directly from within the instrument. It can be downloaded through any asset management system or via the integrated web server. Using Heartbeat Verification during the lifecycle provides traceable and audit-safe test documentation ready for inspection.
Optimize your calibration and cGMP compliance
Heartbeat Technology with Radar Accuracy Index (RAI): Level measurement accuracy verification with the new generation Micropilot 80 GHz radar sensor.
Heartbeat Technology Radar Accuracy Index (RAI) is a patented technology that assesses the reference accuracy of a Micropilot without process interruption.
Increase your plant performance with Heartbeat Technology for diagnostics, verification and monitoring
Benefits
Instruments with Heartbeat Technology are designed to deliver consistent and reliable measuring values for many years of operation. The Heartbeat Verification capabilities allow for wet calibrations to be significantly reduced without jeopardizing compliance. Fewer calibrations also lead to better overall equipment effectiveness and increases plant availability. The reliable data and certified proof that process values are correct between calibration events reduces the risk of quality issues.
1.5 hours
time saved per verification
500 - 1'000 Euro
saved annually on calibration depending on the device
This white paper shows how instrumentation with integrated verification functionalities facilitates the implementation of “Quality by Design” (QbD) and provides full regulatory compliance. Learn more!
This white paper will explain how in-situ verification technologies such as Heartbeat Technology can be used
even in strictly regulated industries and be a part of a compliant system. Learn more!
This white paper explains how self-calibrating thermometers can be used in hygienic process engineering. It details theory and practice as well as application examples. Learn more!
Water, beverages, dairy products, chemicals or pharmaceuticals have to be analyzed every day. Choose the device best suited to your process needs from our comprehensive product portfolio.
Flowmeter
Flowmeter
Water, natural gas, steam, mineral oil, chemicals are some of the fluids that have to be measured day in, day out. Select the flowmeter best suited to your process needs.
Level
Level
Continuous level measurement and point level detection in liquids and bulk solids
Pressure
Pressure
Powerful instruments for process pressure, differential pressure, level and flow.
Software
Software
Apart from all relevant measuring and system technologies, we also offer appropriate software for all branches of industry that provide to run your operating processes at its full potential.
System products
System products
Applicator
Temperature measurement
Temperature measurement
Thermometers and transmitters for the process industry
Instrumentation Services
Instrumentation Services
Maximize plant performance, minimize OPEX, increase uptime, all with compliance. Partner with Endress+Hauser instrumentation services.
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