The recommended frequency for calibrating and verifying thermocouples (TCs) in thermal validation processes depends on several factors — including regulatory requirements, internal quality procedures, and the level of risk a company is willing to manage.
From a best-practice perspective — especially in GMP-/FDA-regulated industries such as pharmaceuticals, biotechnology, and medical device manufacturing — frequent thermocouple calibration is essential to ensure measurement accuracy and data integrity.
RISK-BASED APPROACH:
The decision whether to calibrate TCs before each qualification run and verify after each run or after multiple runs is ultimately a matter of risk management. The more frequently calibration and verification are performed, the lower the risk of undetected measurement drift or sensor failure.
• Some companies may choose to calibrate/ verify only after several qualification campaigns, based on historical stability and internal validation protocols.
• Others — especially those under strict oversight or with critical temperature-sensitive processes — may require calibration before every qualification and verification after each run.
Highest level of assurance:
To achieve the highest level of measurement confidence, regulatory traceability, and audit-readiness, the following calibration cycle is recommended:
1. Calibration & Adjustment before each validation run:
2. Post-calibrate after each validation run:
3. Documentation:
All calibration and verification data should be documented in the GMP calibration report and linked to the batch or qualification file