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
The challenge: preventing tablet coating deviations caused by unreliable temperature data
Tablet coating requires stable drying conditions to produce a uniform coating and protect product quality. Exhaust air temperature indicates how effectively heat and moisture are being removed from the coater. If the temperature is too high, heat-sensitive active ingredients may degrade. If it is too low, insufficient evaporation can leave tablets wet, causing sticking, coating defects, rework, or batch loss.
Manufacturers therefore need reliable evidence that the temperature values used for process control remain accurate throughout production. Conventional calibration requires the thermometer to be removed from the process, calibrated, documented, and reinstalled. In GMP-regulated manufacturing, these interventions increase maintenance effort and can interrupt production. Undetected sensor drift between calibration intervals also reduces confidence in process data and can lead to investigations, audit concerns, or batch rejection.
Temperature measurement points in a pharmaceutical tablet coater
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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