What Are The Emergency Measures When ISO 5 To ISO 8 Cleanrooms Particle Partial Abnormalities Occur?

Emergency Response Levels

Responses are initiated based on the severity of particle size violations:

Level 1 Response (Alert)

• Particle concentration exceeds the alert threshold (e.g., particles ≥0.5μm exceed the standard by less than 50%).

• Action: Double the frequency of real-time monitoring and verify personnel operations and equipment status.

Level 2 Response (Intervention)

• Particle concentration exceeds the intervention threshold (e.g., particles ≥0.5μm exceed the standard by more than 50%, or particles ≥5μm exceed the standard for a sustained period).

• Action: Immediately suspend the production line, isolate the contaminated area, and initiate a root cause investigation.

Level 3 Response (Severe)

• Particle concentration continues to rise or is accompanied by microbial excess.

• Action: Complete production halt, evacuation, and environmental sterilization.

Emergency Measures

Source Control

• Personnel Actions: Check the tightness of Cleanroom clothing and compliance with hand sanitizer procedures, and restrict access to non-essential personnel.

• Equipment and Materials: Deactivate suspected dust-generating equipment and seal material transfer openings.

Environmental System Interventions

• Ventilation System: Increase air changes to ≥50 times/hour, check HEPA Filter tightness, and repair or replace leaks.

• Airflow and Pressure Differential: Correct airflow patterns to ensure a positive pressure of ≥10 Pa in the room.

Cleaning and Disinfection

• Immediate Cleaning: Wipe surfaces with 0.2% chlorhexidine or 2% phenol solution, then spray disinfectant and ventilate the room for 30 minutes.

• Severe Contamination: Perform formaldehyde fumigation (concentration 10g/m³), seal for 24 hours, then ventilate to a residual concentration of <0.5ppm.

Monitoring and Verification

• Particle Concentration: Perform three consecutive measurements (30-minute intervals) to restore to static standards (e.g., Class B ≥0.5μm particles ≤352,000/m³).

• Microbiology: ≤5 CFU/dish (90mm Ø dish, 4-hour exposure).

Responsibilities and Deadlines

Subsequent preventive measures

System optimization

• Monthly HEPA filter integrity checks, with an annual leakage rate of ≤0.01%.

• Quarterly airflow pattern tests to ensure unidirectional flow without dead spots.

Personnel management

• Semi-annual emergency procedures drills and cleanroom operating procedures review.

Record Requirements

• Real-time records: Time, concentration, actions taken, and responsible individuals when particles exceed the specified limit.

• Final Report: Root cause analysis, corrective and preventive actions (CAPA), and verification data.