Operation and Calibration of Thermo-Hygrometer

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Operation and Calibration of Thermo-Hygrometer

1. Purpose

To define the standard procedure for operation, monitoring, and calibration of thermo-hygrometers used for measuring temperature and relative humidity in pharmaceutical controlled areas, ensuring accuracy, reliability, and compliance with regulatory guidelines and GMP requirements.

2. Scope

  • QC Laboratories
  • Stability Storage Areas
  • Warehouses and controlled storage areas

3. Responsibilities

Role Responsibility
QC Analyst / User Routine operation, monitoring, and recording of readings
QC Supervisor Review monitoring logs and ensure compliance
Quality Assurance Oversight, deviation handling, and audit readiness
Engineering / Calibration Personnel Perform instrument calibration and maintenance

4. Equipment & Materials

  • Digital Thermo-Hygrometer
  • Reference Thermo-Hygrometer (ISO/IEC 17025 traceable)
  • Humidity chamber / salt solution kit (for RH calibration)
  • Authorized Log Sheets / Calibration Records
  • Valid Calibration Certificates

5. Operation Procedure

  • Check instrument for physical damage, clean sensor, and verify battery/power supply.
  • Ensure instrument has a valid calibration and label attached.
  • Place the thermo-hygrometer at a representative location in the controlled area, away from direct sunlight, doors, HVAC vents, or walls.
  • Switch ON the device and allow stabilization for 10–15 minutes or as per manufacturer manual.
  • Check display units: Temperature (°C) and Relative Humidity (%RH).
  • Record readings on authorized log sheet:
    • Date & Time
    • Temperature (°C)
    • Relative Humidity (%RH)
    • Operator Name / Signature
  • Monitor readings at defined frequency (continuous via data logger preferred, otherwise at least twice per shift).
  • If readings are outside acceptable limits, immediately notify QC Supervisor and initiate corrective actions (adjust HVAC, relocate samples, etc.).
  • Maintain log sheets as per GDP and audit requirements.

6. Calibration Procedure

6.1 Pre-Calibration Checks

  • Inspect instrument for damage, cleanliness, and proper function.
  • Ensure reference standard is valid, traceable, and within calibration due date.
  • Allow both instruments to stabilize in controlled environment (30–60 minutes).
  • Record instrument details: ID, serial number, model.

6.2 Calibration Frequency

  • Routine: Every 6–12 months.
  • After repair, battery replacement, or abnormal readings.

6.3 Calibration Method – Temperature

  • Use controlled environment or reference thermometer.
  • Measure at minimum three points: Low, Mid, High within operating range.
  • Allow stabilization at each point for at least 5 minutes.
  • Record readings and calculate deviation: Deviation = Instrument – Reference
  • Deviation must be within ±2.0°C (or as per manufacturer manual).

6.4 Calibration Method – Relative Humidity

  • Use humidity chamber or saturated salt solutions.
  • Check at minimum three RH points: Low, Mid, High (30–75%).
  • Equilibrate instrument for 20–30 minutes per point.
  • Record RH readings and calculate deviation.
  • Deviation must be within ±5% RH.

6.5 Post-Calibration Activities

  • Affix calibration label with calibration date and next due date.
  • Attach calibration certificate to instrument file.
  • If any point fails, mark instrument as OUT OF CALIBRATION and remove from use.
  • Notify QC Supervisor and QA, perform impact assessment and initiate deviation report.

7. Area-Specific Environmental Limits

Area Temperature Relative Humidity
QC Lab 20–25°C 40–60% RH
Stability Area 25±2 / 30±2 / 40±2°C 60±5 / 65±5 / 75±5%
Warehouse 15–30°C ≤65% RH

8. References

  • WHO Technical Report Series – GMP
  • ICH Q7, Q9, Q10
  • USP <659> and USP <1079>
  • EU GMP Guidelines – EudraLex Volume 4
  • ISO 9001
  • ISO/IEC 17025
  • Manufacturer’s Instruction Manual (Thermo-Hygrometer)

© 2026 sopnest.blogspot.com. All rights reserved. This content is independently written and intended for educational purposes. References to regulatory guidelines are for compliance guidance only.

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