✅ How to Conclude Temperature Mapping (Step-by-Step)

 

✅ How to Conclude Temperature Mapping (Step-by-Step)

🔹 1. Verify Mapping Objectives Were Met

  • Were the defined monitoring conditions (duration, loading, door openings) followed?

  • Were the data loggers calibrated and placed as per the protocol layout?

🔹 2. Analyze Data from All Data Loggers

  • Review minimum, maximum, and average temperature values for each location.

  • Identify hot spots and cold spots (locations with highest and lowest recorded values).

  • Compare readings against the defined acceptance criteria in the protocol.

🔹 3. Evaluate Acceptance Criteria

Typical Criteria (based on storage requirement):

ConditionCriteria
Room Temperature15–25°C (typical)
Cold Room2–8°C
Freezer-15 to -25°C
Temperature ExcursionShould be < ±2°C for short duration (as per protocol)

Also confirm:

  • No logger exceeded temperature limits

  • All areas returned to normal quickly after door opening or power failure (if simulated)

🔹 4. Identify Out-of-Spec or Deviations (if any)

  • If any data logger recorded out-of-limit temperatures, assess:

    • Duration and severity of deviation

    • Location (e.g., near door or vent)

    • Root cause analysis

    • Risk to product

🔹 5. Document Key Observations

Include in the report:

  • Number of data loggers, calibration status

  • Mapping layout diagram

  • Environmental conditions (empty/loaded, door operations)

  • Hot and cold spot identification

  • Compliance with criteria

  • Summary graphs and tables

  • Deviations, CAPA if any

🔹 6. Conclude with Final Statement

✅ Example Conclusion Statement:

"Temperature mapping of the cold room was conducted over a 72-hour period under loaded conditions using 27 calibrated data loggers. The temperature was maintained within the specified range of 2–8°C throughout the study. No excursions beyond acceptable limits were observed. Based on the data analysis and mapping objectives, the area is qualified and suitable for storage of temperature-sensitive pharmaceutical products."

If deviations occurred:

"One data logger near the door recorded a temperature of 8.5°C for 6 minutes during door opening simulation, which was predefined in the protocol as acceptable. Therefore, the excursion is considered within risk-based limits, and the room is considered qualified with justification."

📄 Final Report Must Include:

  • Executive summary

  • Protocol reference

  • Mapping layout

  • Data tables and graphs

  • Hot/cold spot identification

  • Compliance assessment

  • Deviations and CAPA

  • Qualification status (Qualified / Not Qualified)

  • QA approval and sign-off

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