An In Situ Air Pattern Analysis—commonly called a Smoke Study (or Airflow Pattern Test / AFPT)—is a visualization test performed in GMP cleanrooms and aseptic processing areas. It uses visible tracer smoke to confirm airflow directionality and behavior, helping verify unidirectional flow, assess contamination control, and demonstrate performance consistent with ISO 5 / Grade A expectations.
In GMP-regulated environments, airflow is a primary contamination-control mechanism. Pharma, biotech, and sterile manufacturing operations rely on smoke studies to verify airflow performance in:
- Cleanrooms (ISO 5 / Grade A critical zones)
- Biosafety cabinets (BSCs)
- Isolators and RABS
- Aseptic processing and sterile manufacturing areas
Smoke studies help substantiate that airflow supports product protection—especially around critical operations, interventions, and equipment layouts.
Our Smoke Study service for GMP facilities includes:
- Onsite airflow visualization using tracer smoke in critical areas
- High-definition video capture for review, training, and audit support
- Professional reporting aligned to common regulatory expectations and industry best practices
- Expert interpretation to identify airflow concerns (turbulence, stagnation, disruption points) and document findings clearly
Smoke Studies are commonly performed:
- During initial qualification/validation of cleanrooms and critical zones
- After changes (facility upgrades, equipment relocation, HVAC adjustments, process changes)
- During routine requalification, often annually or per your internal quality program and risk assessment
Scheduling is easy! Contact Quantus through our Request Service form or email: service@goquantus.com, and our experts will coordinate a GMP-compliant Smoke Study at your pharmaceutical, biotech, or sterile manufacturing facility. We provide onsite testing, regulatory documentation, and detailed reporting to support audits and compliance.
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