Cleanroom Validation (ISO 14644)

Cleanroom Validation (ISO 14644)

Cleanrooms and controlled environments are critical to maintaining product integrity during the manufacture of sterile medical devices. IETQAN conducts comprehensive HVAC and cleanroom validation in full compliance with ISO 14644, ensuring that your controlled environment consistently meets the specified particulate cleanliness classification and environmental conditions. Our cleanroom validation scope includes:

• Airborne particulate cleanliness classification testing.
• HEPA filter integrity testing (DOP/PAO testing).
• Airflow volume and velocity measurement.
• Air pressure differential testing.
• Temperature and humidity uniformity mapping.
• Recovery and containment testing.
• Microbial environmental monitoring.

IETQAN’s validation protocols and reports are prepared in accordance with ISO 14644-1/-2 and the requirements of applicable GMP guidelines, providing documentation that satisfies both initial qualification and ongoing requalification requirements.