Cleaning Validation Engineer

Cleaning Validation Engineer

to perform smoke studies

More about what the role is / what they are doing….

In a cleanroom validation environment , a smoke study (also called an airflow visualization study ) is a qualification test used to verify that clean, HEPA-filtered air moves through the room as intended and protects products from contamination.

What happens during a smoke study?

Validation engineers release a visible, non-contaminating smoke or fog into a cleanroom, isolator, biosafety cabinet, or manufacturing area and observe how the airflow behaves. The study is typically video-recorded for validation and regulatory documentation.

What are they looking for?

They evaluate whether the airflow:

• Remains unidirectional (laminar) where required
• Reaches critical product-contact areas with "first air"
• Avoids turbulence, eddies, or stagnant zones
• Prevents contamination from operators, equipment, or adjacent areas
• Maintains proper cleanroom protection during normal operations and interventions

Why are smoke studies important?

Smoke studies are commonly required as part of:

• Cleanroom qualification and requalification
• HVAC validation
• ISO 14644 compliance
• FDA and EU GMP inspections
• Aseptic processing validation in pharmaceutical, biotech, and medical device manufacturing

Example

If a pharmaceutical company fills sterile injectable products under an ISO 5 hood, a validation engineer may perform a smoke study to ensure the airflow sweeps particles away from open vials. If the smoke shows turbulence around an operator's hands or equipment, corrective actions might include repositioning equipment, adjusting airflow, or changing operator techniques.