1.0 Purpose

To describe the procedure for performing a heat distribution study in a depyrogenation oven using multiple temperature probes connected to a data logger, ensuring uniformity of heat throughout the chamber.

2.0 Scope

This SOP applies to all heat distribution studies conducted in depyrogenation ovens installed in the pharmaceutical facility.

3.0 Responsibility

• Validation/Engineering Department: Perform heat distribution study and ensure calibration of probes and data logger.
• Microbiology/Production: Support study execution and provide access to equipment.
• QA Department: Review and approve study protocol, data, and report.

4.0 Materials and Equipment

• Calibrated data logger with multiple probes
• Calibrated temperature probes (as per mapping plan)
• Depyrogenation oven (clean and qualified)
• Computer with validated software for data analysis
• Logbook/study protocol documentation

5.0 Procedure

5.1 Pre-Requisites

1. Ensure the depyrogenation oven is clean and ready for study.
2. Verify calibration status of all probes and data logger.
3. Prepare study protocol including probe locations, acceptance criteria, and run details.
4. Wear required PPE while performing study.

5.2 Placement of Probes

1. Place probes at predetermined locations as per mapping plan, covering:
   • Corners (all 4)
   • Center (1)
   • Middle shelves (front, middle, back)
   • Top and bottom levels
   • Door side and rear side
2. Secure probes properly to avoid displacement during operation.
3. Connect probes to the data logger.

5.3 Execution of Heat Distribution Study

1. Set the depyrogenation oven cycle as per validated operating parameters.
2. Start the data logger and ensure continuous recording at set intervals (e.g., every 1–2 seconds).
3. Allow the oven to complete the full cycle (heating, holding, and cooling).
4. Monitor critical phases such as heating rate, attainment of set temperature, hold time, and cooling rate.

5.4 Data Collection and Analysis

1. After cycle completion, stop the data logger and download data to the computer.
2. Generate graphical trends and tabulated data for each probe.
3. Compare probe readings to verify uniformity across chamber.
4. Acceptance criteria:
   • All probes should achieve and maintain the required depyrogenation temperature (e.g., ≥ 250°C for specified hold time).
   • Temperature variation between probes should be within ±15°C (or as per protocol).
5. Document results in study report.

5.5 Post-Study

1. Remove probes carefully and clean if required.
2. Store data logger and probes in designated storage.
3. Archive all raw data, analyzed reports, and reviewed documents.

6.0 Safety Precautions

• Handle probes and wires carefully to avoid burns after oven operation.
• Use PPE (heat-resistant gloves, goggles, gown).
• Do not open the oven door during operation unless in emergency.

7.0 Documentation

• Record study details in protocol and report.
• Maintain electronic and hard copies of data for audit purposes.
• QA to review and approve final report.

8.0 References

• EU GMP Annex 1
• ISO 17665 and ISO 13408
• Manufacturer’s Manual for Depyrogenation Oven
• WHO Technical Report Series (TRS)#DepyrogenationOven

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