Standard Operating Procedure for Calibration of Temperature Probes in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/130/2025 |
| Supersedes | SOP/ELX/130/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standardized procedure for the calibration of temperature probes used in elixir manufacturing to ensure accurate and reliable temperature measurements during critical production processes.
2. Scope
This SOP is applicable to all digital, RTD, thermocouple, and infrared temperature probes installed on vessels, pipelines, and process control systems in the Elixir Department.
3. Responsibilities
- Engineering Department:
- Perform calibration using traceable standards and maintain calibration records.
- Production Supervisor:
- Ensure only calibrated temperature probes are used for batch operations.
- QA Officer:
- Review calibration certificates and verify traceability to national/international standards.
4. Accountability
The Engineering Head is accountable for calibration accuracy, and the Production Head is accountable for the implementation of calibrated devices in processing areas.
5. Procedure
5.1 General Guidelines
- Calibration shall be performed:
- At defined intervals (e.g., every 3 months)
- Before first use after
installation
After maintenance or suspected deviation in readings
Calibration shall be conducted using a standard thermometer or dry block calibrator traceable to a national standard.
5.2 Calibration Procedure
- Switch off power to the equipment and disconnect the probe if necessary.
- Clean the probe tip with lint-free cloth and ensure it is free from residue.
- Immerse the probe in a temperature calibrator set at three points (e.g., 25°C, 60°C, 80°C) relevant to operational range.
- Allow readings to stabilize for at least 3 minutes at each temperature point.
- Record the displayed temperature and compare with standard value.
- Calculate deviation:
- If within ±0.5°C, mark as PASS.
- If outside, recalibrate or replace probe.
- Label probe with calibration status, due date, and reference ID.
5.3 Documentation
- Record calibration data in the Temperature Probe Calibration Log (Annexure-1).
- Attach calibration certificate if external service is used.
- Update the Equipment Master Calibration Register.
5.4 Post-Calibration Handling
- Reinstall the probe and test for connectivity before initiating batch operation.
- Inform QA for verification if calibration was done mid-batch or during critical operation.
5.5 Safety and Precautions
- Always wear gloves when handling probes to avoid contamination or burns.
- Handle dry block calibrators carefully; allow cooling before storing.
- Use only approved buffer/medium and never force a probe into a blocked port.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- RTD: Resistance Temperature Detector
- GMP: Good Manufacturing Practice
7. Documents
- Temperature Probe Calibration Log (Annexure-1)
- Calibration Certificate
- Equipment Master Calibration Register
8. References
- 21 CFR Part 211.68 – Automatic, Mechanical, and Electronic Equipment
- WHO GMP Guidelines – Equipment Calibration
- ICH Q9 – Quality Risk Management
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Temperature Probe Calibration Log
| Date | Equipment ID | Set Temp (°C) | Observed Temp (°C) | Deviation | Status | Calibrated By |
|---|---|---|---|---|---|---|
| 11/04/2025 | TP-ELX-03 | 60.0 | 59.7 | -0.3°C | Pass | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added 3-point calibration instructions | Regulatory Compliance | QA Head |