1.0 Purpose

To describe the standard procedure for the safe and effective operation of the Fogster-ULV (Ultra-Low Volume) Fogger Machine for disinfection of classified and controlled areas in the facility.

2.0 Scope

This SOP applies to all trained personnel responsible for using the ULV Fogger machine for environmental disinfection in sterile and controlled manufacturing areas.

3.0 Responsibility

• Production/Microbiology/Housekeeping Staff: Operate the fogger machine as per this SOP.
• Engineering Department: Maintain the fogger machine and perform preventive maintenance.
• QA Department: Ensure compliance and review fogging activity records.

4.0 Materials and Equipment

• ULV Fogster Fogger Machine
• Approved disinfectant/fumigant solution (e.g., Hydrogen Peroxide, QAC solution)
• Sterile water for dilution (if required)
• Personal Protective Equipment (PPE): sterile gown, gloves, goggles, mask/respirator
• Fogging logbook

5.0 Procedure

5.1 Pre-Operation Checks

1. Ensure the fogger machine is clean and in working condition.
2. Verify the disinfectant solution is within expiry and properly labeled.
3. Wear appropriate PPE before handling the disinfectant and machine.
4. Ensure the area to be fogged is clean and free of personnel.

5.2 Preparation of Disinfectant Solution

1. Prepare disinfectant solution in a clean container as per manufacturer’s recommended dilution.
2. Fill the fogger tank with the prepared solution under aseptic precautions.
3. Do not overfill the tank (maximum fill line must be respected).

5.3 Operation of ULV Fogger

1. Place the fogger in the designated area ensuring even distribution of fog.
2. Set timer or manual control as per area volume and required exposure time.
3. Switch on the fogger and allow uniform fogging of the area.
4. Exit the room immediately after fogging starts.
5. Ensure the room remains closed for the required contact time (minimum 30–60 minutes or as per disinfectant guidelines).

5.4 Post-Operation

1. After completion, switch off the fogger and remove remaining disinfectant solution safely.
2. Clean and dry the fogger tank with sterile water.
3. Store the fogger machine in a clean and designated storage area.
4. Record fogging details (date, time, disinfectant used, batch no., operator initials) in the logbook.

6.0 Safety Precautions

• Do not remain inside the area during fogging.
• Always use PPE while handling disinfectants.
• Avoid direct inhalation or skin contact with fog/mist.
• Ensure proper ventilation after contact time before re-entry.

7.0 Documentation

• Maintain records of fogging in the logbook.
• Attach disinfectant preparation and usage details.
• QA to verify and review periodically.

8.0 References

• Manufacturer’s Manual for ULV Fogger Machine
• Facility Disinfection Policy
• EU GMP Annex 1
• ISO 14644 Standards

🎓 Discover one of the best Pharmaceutical Microbiology course available —click below to explore the course that’s shaping future Microbiology course skills.

https://trcjw.on-app.in/app/oc/471801/trcjw