Standard Operating Procedure for Temperature Mapping in Drying Chambers in API Manufacturing

Department	API Manufacturing
SOP No.	SOP/API/072/2025
Supersedes	SOP/API/072/2022
Page No.	Page 1 of 10
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To establish a validated procedure for performing temperature mapping in drying chambers, including tray dryers, vacuum ovens, and fluid bed dryers, to confirm uniform temperature distribution during operation.

2. Scope

This SOP applies to all drying chambers used in API manufacturing that require temperature validation or requalification following installation, major maintenance, or at predefined intervals.

3. Responsibilities

• Validation/Engineering Team: Plan and execute temperature mapping protocol using calibrated sensors.
• QA Department: Review and approve the temperature mapping protocol and final report.
• Production Department: Provide equipment access and coordinate operations during mapping activity.

4. Accountability

The Validation Head is accountable for ensuring correct execution of temperature mapping. The QA Head is responsible for verifying compliance and approving validation documentation.

5. Procedure

5.1 Pre-Mapping Preparation

1. Develop and approve a validation protocol describing:
   • Number and location of sensors (minimum 9-point grid for small chambers, 15–21 for larger)
   • Duration of mapping
   • Acceptance criteria (±3°C unless otherwise justified)
   • Calibration details of sensors/data loggers
2. Ensure the chamber is clean and empty before mapping unless performing loaded qualification.
3. Label each sensor with location and record serial number.

5.2 Sensor Placement

1. Place temperature sensors:
   • Top-left, top-center, top-right
   • Middle-left, middle-center, middle-right
   • Bottom-left, bottom-center, bottom-right
2. In large chambers, additional sensors should be placed at airflow entry/exit and dead zones identified in prior studies.

5.3 Data Collection

1. Set chamber to standard operating temperature (e.g., 60°C for vacuum dryers).
2. Begin mapping when steady state is achieved (stabilization time ~30–60 minutes).
3. Record temperature readings at 1–5 minute intervals for a minimum of 2 hours or as per protocol.
4. Download and save data from each logger in electronic format.

5.4 Data Analysis and Reporting

1. Analyze temperature variation across all sensors.
2. Calculate maximum, minimum, and average temperature.
3. Identify cold/hot spots and verify all readings fall within acceptance limits.
4. Prepare and submit “Temperature Mapping Report” (Annexure-1) including graphs and summary.

5.5 Post-Mapping Activities

1. Remove all sensors and restore equipment to operational readiness.
2. Label equipment as “Validated” and update equipment validation status log.
3. If mapping fails, perform investigation and corrective actions before repeat mapping.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• FBD: Fluid Bed Dryer
• °C: Degree Celsius
• CSV: Computer System Validation

7. Documents

1. Temperature Mapping Report (Annexure-1)
2. Validation Protocol and Summary
3. Sensor Calibration Certificate

8. References

• WHO TRS 961 Annex 9 – Temperature Mapping of Storage Areas
• ICH Q8 – Pharmaceutical Development
• US FDA Guidance on Process Validation

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 Mapping Report Summary

Date	Equipment ID	Set Temp (°C)	Max (°C)	Min (°C)	Avg (°C)	Pass/Fail
13/04/2025	TRAY-DRY-01	60	62.1	58.3	60.2	Pass

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New Process Equipment Commissioning	QA Head
13/04/2025	2.0	Updated sensor layout and acceptance criteria	GMP Audit Compliance	QA Head