Portfolio
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.
Key facts
20%
only 20% of instruments are set up with an ideal calibration interval
Process overview
Optimize your calibration and cGMP compliance
Insights
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.
- Still wondering how exactly Heartbeat Technology can pass regulatory audits? Read our white paper "Heartbeat Technology authority recognition" on how in-situ verification technologies can be used even in GMP environments.
Insights
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.
Insights
Verification made simple and fast
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.
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.
Key facts
1.5 hours
time saved per verification
Key facts
500 - 1'000 Euro
saved annually on calibration depending on the device
Takeaway
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