How is plasma and blood fractionation performed in laboratories?
Endress+Hauser's iTHERM TrustSens TM371 and TM372 help blood fractionation facilities strengthen confidence in critical temperature measurements through automated self-calibration and traceable verification compliance
Summary
Blood fractionation facilities rely on accurate temperature measurement to transform human plasma into therapies like albumin, immunoglobulins and clotting factors. Because these products directly impact patient health, the manufacturing process must be tightly controlled. Temperature is a critical process variable that influences product quality, process consistency and validation activities, but traditional calibration can leave uncertainty between scheduled checks. Endress+Hauser iTHERM TrustSens TM371 and TM372 provide an advanced solution using self-calibration technology.
The benefits:
Self-calibration technology turns manual maintenance into continuous measurement confidence. Automated verification reports provide quality teams clear, traceable evidence of sensor performance, allowing them to spend less time collecting documentation and more time focusing on data analysis.
With real-time access to device health, TrustSens can help detect sensor drift sooner than traditional calibration schedules. Earlier visibility supports proactive maintenance and helps teams address potential issues before they become quality or compliance risks. In blood fractionation, this can help reduce unnecessary costs, downtime and disruption to high-value batches.
The technology also supports life sciences compliance by equipping operators with time stamped, complete and easy-to-trace data for product quality verification and operational decision-making.
Endress+Hauser iTHERM TrustSens TM371 and TM372 provide a complete solution by shifting temperature measurement from a manual, periodic activity to an automated source of evidence that supports validation, reduces risk and improves audit readiness.
What are self-calibrating thermometers?
A self-calibrating thermometer is a temperature sensor that can automatically verify its own accuracy while it is still operating in the process, rather than waiting for a technician to perform a scheduled calibration.
Why is temperature important in blood fractionation?
Temperature measurement is important in blood fractionation because it helps ensure the quality, consistency and safety of plasma-derived therapies such as albumin, immunoglobulins and clotting factors. Accurate temperature monitoring supports process validation, regulatory compliance, batch integrity and reliable product manufacturing.
The challenge:
Blood fractionation processes operate in a highly regulated manufacturing environment where quality teams must demonstrate that critical instruments are performing as intended. GMP, FDA 21 and Annex 15 requirements emphasize reliable records and process control, making accurate temperature measurement essential to compliance and product integrity.
Many facilities rely on scheduled calibration to verify sensor performance, but each check only proves accuracy at that moment. If a sensor drifts afterward, the issue may go unnoticed until the next scheduled calibration, increasing uncertainty and audit preparation effort. If an issue is found, traditional calibration may also require removing the sensor or stopping production.
For blood fractionation operations, this uncertainty creates added risk because products are high value and batch integrity is crucial. Manufacturers need reliable data without extended periods of uncertainty, process disruption or facility downtime.
Our solution:
Endress+Hauser iTHERM TrustSens TM371 and TM372 are temperature measurement devices, equipped with self-calibration technology, used in hygienic applications. In addition to a standard Pt100 sensing element, they incorporate a built-in reference point that allows the devices to automatically verify measurement accuracy during operation. When conditions are met, the sensors compare measured values to the internal reference, permitting in-situ calibration and verification without removing the sensor removing the sensor from service or interrupting production.
iTHERM TrustSens TM371 and TM372 can now support more Life Sciences processes. A 102°F (39°C) calibration point extends self-calibration benefits into lower temperature hygienic processes where traditional calibration may be less practical. This technology helps blood fractionation facilities improve confidence in temperature measurement and documentation throughout production.
In applications with strict regulatory oversight, TrustSens devices, equipped with Heartbeat Technology, simplify compliance documentation by automatically generating records that include the device ID, time stamp and verification result. These reports give quality and validation teams readily accessible evidence that assets are operating as intended, reducing manual documentation effort and supporting audit preparation.
By providing real-time verification of sensor performance, TrustSens increases visibility into sensor health, supports data integrity and reduces uncertainty between calibration events.
