Understand how smoke studies visualize airflow, identify critical airflow risks, and support contamination control and GMP compliance.
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Rising expectations under EU GMP Annex 1, USFDA, WHO, PIC/S, and CDSCO for Grade A zones and Grade B ingress points.
Turbulence, dead zones, and reverse airflow that go unnoticed until an EM excursion or audit.
Incorrect smoke generation, missed worst-case operator interventions, and weak acceptance criteria.
This session is designed for professionals responsible for cleanroom performance and sterility assurance across pharmaceutical, biologics, cell and gene therapy, CMO, medical device, and hospital compounding facilities:
In 90 minutes, we will unpack the real challenges teams face with smoke studies, walk through practical solutions, and answer your questions live.
Clear answers to your pressing challenges. The speaker answers questions submitted during registration.
Common questions we tackle:
Gaurav brings over 20 years of expertise in validation, sterile engineering, and project management.
Riya represents IncepBio, a global expert in Pharma Engineering, CQV, and Automation.
About IncepBio:
Share one smoke study challenge when you register. The speaker will answer the most common ones live.
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Quick answers about smoke studies and this webinar.
A smoke study is an airflow visualization test where visible smoke or fog is released in a cleanroom or critical zone to observe how air moves. It confirms that airflow protects the product and reveals issues such as turbulence, dead zones, or reverse airflow.
Yes, for Grade A zones where unidirectional airflow is required. Annex 1 also expects airflow visualization at Grade B ingress points to show that air does not enter from lower-grade areas. The webinar explains these expectations in detail.
At-rest studies show airflow with equipment running but no activity. In-operation studies show airflow during real activities, including operator interventions, which is where most contamination risks appear.
Smoke studies should be repeated when there are changes to equipment, layout, HVAC systems, or interventions, and as part of periodic requalification based on risk. The speaker will cover how to decide this within your Contamination Control Strategy.
Yes, registration is completely free.
Yes. The session includes a live Q&A, and every registrant shares one question in advance through the registration form, so the speaker can address your real challenges.
IncepBio is a Leading Pharma Consulting and Engineering Solution Partner. We deliver cutting-edge pharma automation, turnkey facility engineering solutions, and exclusive platforms like ValBio™ and IncepOne™ designed to meet strict international regulatory standards. With a strong footprint in major pharmaceutical hubs, we provide expert GMP compliance and smoke study documentation for top clients globally.
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