Elimination of Microbial Contamination from Classified Areas

1. Root Cause Identification

Before elimination, identify why contamination occurred:

• Breach in personnel gowning or behavior.

• Ineffective cleaning/sanitization.

• HEPA filter leakage or improper airflow.

• Uncontrolled material movement.

• Defective pass boxes or transfer procedures.

• High particle load from adjacent areas.

• Stagnant water or condensation in the area.

2. Immediate Containment Actions

• Stop aseptic operations in the affected area.

• Quarantine materials, equipment, and in-process batches.

• Inform QA and initiate deviation/CAPA.

• Increase environmental monitoring frequency.

3. Elimination & Remediation Steps

1. Deep Cleaning & Sanitization

   • Perform thorough cleaning using validated disinfectants (e.g., quaternary ammonium, hydrogen peroxide, isopropyl alcohol).

   • Alternate disinfectants to prevent resistance.

   • Apply sporicidal agents (e.g., peracetic acid, chlorine dioxide) if spore-formers are suspected.

2. HEPA Filter & HVAC Checks

   • Perform smoke studies/airflow visualization to confirm laminarity.

   • Conduct HEPA integrity testing (DOP/PAO).

   • Check differential pressures between rooms.

3. Personnel Control

   • Retrain operators on aseptic techniques and gowning.

   • Verify gowning integrity (glove, mask, hood checks).

   • Requalify personnel if repeated failures occur.

4. Material & Equipment Control

   • Review transfer procedures (via pass boxes, airlocks).

   • Ensure all materials are disinfected/sterilized before entry.

   • Use dedicated, cleanroom-graded equipment only.

5. Environmental Decontamination

   • Perform fumigation or VHP (Vaporized Hydrogen Peroxide) cycle for high contamination cases.

   • Use UV light exposure in pass boxes and airlocks as supportive measure.

6. Water System & Utilities Check

   • Test purified water and compressed air lines used in the area.

   • Eliminate stagnant points or leaks that may harbor microbes.

4. Verification of Effectiveness

• Perform follow-up environmental monitoring (air, surface, glove prints).

• Compare results against alert/action limits.

• Document trend analysis to ensure contamination is eliminated.

5. Preventive Measures (CAPA)

• Establish robust cleaning & sanitization schedule.

• Rotate disinfectants periodically.

• Conduct routine HVAC and HEPA filter maintenance.

• Enforce strict gowning discipline and personnel monitoring.

• Review and revalidate classified areas periodically (smoke study, recovery test).

• Implement a contamination control strategy per Annex 1 (EU GMP).

✅ In short:
To eliminate microbial contamination from classified areas, identify the root cause, perform deep cleaning with validated disinfectants, check HVAC/HEPA systems, retrain personnel, and verify effectiveness through enhanced environmental monitoring. Long-term prevention requires a strong contamination control strategy.

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