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
- 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
- Ensure the chamber is clean and empty before mapping unless performing loaded qualification.
- Label each sensor with location and record serial number.
5.2 Sensor Placement
- Place temperature sensors:
- Top-left, top-center, top-right
- Middle-left, middle-center, middle-right
- Bottom-left, bottom-center, bottom-right
- In large chambers, additional sensors should be placed at airflow entry/exit and dead zones identified in prior studies.
5.3 Data Collection
- Set chamber to standard operating temperature (e.g., 60°C for vacuum dryers).
- Begin mapping when steady state is achieved (stabilization time ~30–60 minutes).
- Record temperature readings at 1–5 minute intervals for a minimum of 2 hours or as per protocol.
- Download and save data from each logger in electronic format.
5.4 Data Analysis and Reporting
- Analyze temperature variation across all sensors.
- Calculate maximum, minimum, and average temperature.
- Identify cold/hot spots and verify all readings fall within acceptance limits.
- Prepare and submit “Temperature Mapping Report” (Annexure-1) including graphs and summary.
5.5 Post-Mapping Activities
- Remove all sensors and restore equipment to operational readiness.
- Label equipment as “Validated” and update equipment validation status log.
- 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
- Temperature Mapping Report (Annexure-1)
- Validation Protocol and Summary
- 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 |