1.0 Purpose

To describe the procedure for physical monitoring of the microbiology section to ensure compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and regulatory requirements.

2.0 Scope

This SOP applies to all physical parameters monitoring activities performed in the microbiology laboratory including temperature, humidity, differential pressure, and airflow.

3.0 Responsibility

• Microbiology Staff: Perform and record daily physical monitoring.
• Engineering Department: Maintain instruments/equipment used for monitoring.
• QA Department: Review monitoring records and ensure compliance.

4.0 Parameters for Monitoring

• Temperature: Incubators, refrigerators, freezers, and laboratory rooms.
• Relative Humidity (RH): Controlled rooms.
• Differential Pressure: Between classified cleanrooms (airlocks, gowning rooms, microbiology labs).
• Airflow/HEPA Integrity: Laminar Air Flow (LAF) units, Biosafety Cabinets.
• Light Intensity & Noise Levels: As per occupational health and safety requirements (if applicable).

5.0 Materials and Instruments

• Calibrated thermometers, hygrometers, digital data loggers
• Magnehelic gauge/differential pressure manometer
• Anemometer/Velometer for airflow velocity
• Monitoring logbooks/forms

6.0 Procedure

6.1 Temperature Monitoring

1. Record temperatures of incubators, refrigerators, freezers, and lab areas daily.
2. Compare with acceptance criteria:
   • Refrigerators: 2–8 °C
   • Freezers: -20 °C ± 5 °C
   • Incubators: As per test requirement (e.g., 20–25 °C, 30–35 °C, 37 °C, 55 °C).
3. Record deviations, if any, and report to QA immediately.

6.2 Humidity Monitoring

1. Record RH of controlled areas daily.
2. Acceptable range: 45–65% (or as per facility-defined limits).
3. Take corrective action if outside limits.

6.3 Differential Pressure Monitoring

1. Check and record differential pressures across cleanroom boundaries daily.
2. Acceptable limit: Not less than 10–15 Pa (or as per facility design).
3. Report abnormal readings immediately.

6.4 Airflow Monitoring

1. Verify airflow direction using smoke test (as per validation schedule).
2. Check velocity of LAF/Biosafety Cabinet using anemometer periodically.
3. Ensure HEPA filters are intact and certified.

6.5 General Physical Checks

• Ensure cleanliness and illumination levels are adequate.
• Verify noise level is within occupational health limits.

7.0 Documentation

• Record all physical monitoring data in logbooks or electronic systems.
• QA to review and sign monitoring records.
• Document any deviation and corrective action taken.

8.0 Precautions

• Use only calibrated instruments for monitoring.
• Do not alter or backdate records.
• Report any excursion immediately.

9.0 References

• WHO Technical Report Series on GMP for Sterile Pharmaceutical Products
• EU GMP Annex 1
• ISO 14644 Cleanroom Standards
• Internal Facility Validation Documents

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