In Situ Air Pattern Analysis – ISO 5 & Grade A Smoke Studies | Quantus

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Our Smoke Study (In Situ Air Pattern Analysis) service ensures precise airflow visualization and compliance verification for ISO 5 & Grade A environments.

Regulatory Compliance: Meet and exceed FDA, USP 797, and EU Annex 1 standards with expert airflow analysis.
Unmatched Precision: High-definition video documentation captures unidirectional airflow patterns to validate contamination control.
Operational Confidence: Identify turbulence, dead zones, and airflow disruptions to optimize cleanroom safety and performance.

Partner with Quantus for scientifically rigorous smoke studies that provide actionable insights, ensuring your cleanroom operates at peak efficiency and compliance.

What is an In Situ Air Pattern Analysis (Smoke Study) in a GMP Facility?

An In Situ Air Pattern Analysis, also called a Smoke Study, is a critical test performed in GMP cleanrooms and aseptic processing areas. It visualizes airflow patterns to ensure unidirectional flow, contamination control, and compliance with ISO 5, Grade A, USP 797, and EU Annex 1 regulations.

Why is a Smoke Study essential for the Life Sciences Industry?

Pharmaceutical, biotech, and life sciences companies operating in GMP-regulated environments must perform Smoke Studies to verify proper airflow and contamination prevention in cleanrooms, biosafety cabinets (BSCs), isolators, and sterile manufacturing areas. These studies support regulatory compliance and product integrity.

What does Quantus’s Smoke Study service include for GMP facilities?

Our Smoke Study service for GMP-compliant life sciences facilities includes:

High-definition video documentation of airflow visualization.
Comprehensive compliance reporting aligned with FDA, USP 797, and EU Annex 1 standards.
Expert analysis of airflow performance to identify turbulence and contamination risks in GMP manufacturing environments.

How often should a GMP facility conduct a Smoke Study?

GMP regulations recommend conducting Smoke Studies:

During initial cleanroom validation in life sciences facilities.
After facility upgrades, equipment changes, or process modifications.
As part of routine requalification (annually or per GMP regulatory guidance).

How can my Life Sciences company schedule a GMP-compliant Smoke Study?

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.

I am very pleased with the services provided. The technicians are exceptional to work with, and the customer support team is incredibly responsive and accommodating. The pricing offers excellent value for the services provided.

Century Therapeutics Drew
The technicians here do an outstanding job. I truly appreciate the responsiveness of the customer support team and their proactive approach to scheduling.

Ellume Ken
Everything is going great with the services. The technicians are top-notch – professional, honest, and very solid in their work. They provide excellent communication and feedback.

RegenXBio Blake
Working with Quantus to resolve the disorganization of previous 3rd party reports. I have received positive feedback on the work Quantus is doing. We're looking forward to a meeting with the top management and business development teams to gain more feedback and develop additional controls.

Christiana Care James

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