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Protect tablet coating quality with verified temperature data

iTHERM TrustSens for reliable and traceable temperature measurement in GMP-regulated tablet coating

Iparág: Élettudományok
pill production pharmacy

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Összefoglaló

Stable drying conditions are essential for consistent tablet coating quality. However, conventional calibration can interrupt production, while undetected sensor drift puts batch reliability at risk. iTHERM TrustSens verifies measurement performance through automated in-situ self-calibration. The resulting records support traceable GMP documentation and can be associated with the corresponding production batch.

The benefits: lower calibration effort and reduced batch risk

Automated

in-situ calibration

Traceable

calibration evidence

Reduced

downtime risk

Three ways unreliable temperature data affects coating quality:

Temperature too high

Heat-sensitive active pharmaceutical ingredients may degrade, risking product stability and batch rejection.

Temperature too low

Reduced solvent evaporation leaves the coating wet, causing tablets to stick and coating defects.

Sensor drift or unverified data

Undetected drift between calibrations increases process risk and reduces confidence during audits.

Our solution: verifying temperature accuracy without interrupting production

iTHERM TrustSens TM371 (metric) / TM372 (imperial) verify measurement performance through automated in-situ self-calibration. An integrated physical reference provides a traceable calibration signal, helping identify sensor drift without removing the thermometer from the process. This reduces calibration-related intervention while maintaining confidence in the temperature data used to control tablet drying.

In the tablet coater, the thermometer can monitor critical temperatures such as exhaust air, inlet air, coater air, or product temperature. When the equipment cools after the coated tablets have been removed, a self-calibration can be performed and the resulting calibration record assigned to the corresponding production batch. This supports traceable GMP documentation, risk-based calibration strategies, and more reliable batch decisions.

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