1.0 Purpose

To describe the procedure for the operation, monitoring, and data handling of data loggers used in the microbiology laboratory, controlled areas, warehouses, and cold storage rooms.

2.0 Scope

This SOP applies to all data loggers used for monitoring environmental conditions such as temperature, humidity, and pressure in pharmaceutical facilities.

3.0 Responsibility

• User Department (Microbiology/Production/Stores): Operate and maintain the data logger as per this SOP.
• Engineering Department: Calibrate and maintain the data loggers.
• QA Department: Review and verify recorded data for compliance.

4.0 Materials and Equipment

• Data logger (calibrated)
• Data logger software (if applicable)
• Computer system for data retrieval
• Logbook/records

5.0 Procedure

5.1 Pre-Use Checks

1. Verify calibration status of the data logger.
2. Ensure the battery/power supply is sufficient for operation.
3. Confirm logger is clean and free from damage.

5.2 Installation/Placement

1. Place the data logger at the designated location (e.g., incubator, refrigerator, cleanroom, warehouse).
2. Ensure it is not placed directly near vents, doors, or windows to avoid false readings.
3. Secure placement to prevent accidental movement.

5.3 Operation

1. Switch on the data logger.
2. Set parameters such as logging interval, date, and time as per requirement.
3. Start data recording by pressing the appropriate function key or through software.
4. Ensure the logger is continuously running during the monitoring period.

5.4 Data Retrieval

1. Connect the data logger to a computer using USB/cable or wireless connection.
2. Download recorded data using the approved software.
3. Save the data in secured electronic folders with proper naming convention (e.g., Equipment Name_Date).
4. Take a printout of the data if required and paste it in the respective logbook.

5.5 Post-Use

1. After data download, clear the memory (if applicable) and reset for next use.
2. Store the data logger in a designated storage cabinet when not in use.
3. Record usage details in the data logger usage logbook.

6.0 Safety Precautions

• Handle data loggers with care; avoid dropping or exposing to moisture.
• Do not use expired or non-calibrated devices.
• Ensure only trained personnel operate the logger and software.

7.0 Documentation

• Maintain a logbook for data logger usage.
• Archive downloaded data for future reference and audits.
• QA to review periodically.

8.0 References

• Manufacturer’s User Manual for Data Logger
• WHO Technical Report Series on GMP
• 21 CFR Part 11 (for electronic records compliance, if applicable)

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