Airflow Visualisation (Smoke studies) & Cleanroom Compliance in Biopharma
This 4-session webinar series provides a comprehensive, practitioner-led exploration of cleanroom design, airflow visualisation, and qualification requirements under EU GMP Annex 1 (2022), ISO 14644, and FDA aseptic processing guidance.
Cleanroom design and airflow control sit at the very core of contamination prevention in biopharmaceutical manufacturing. As regulatory expectations intensify — most notably with the release of EU GMP Annex 1 (2022) — organisations are under mounting scrutiny to demonstrate that every Grade A and Grade B zone performs as intended, not just on paper, but in live, operational conditions.
This 4-session webinar series, From Smoke to Compliance, is designed to deliver a complete, practitioner-led journey through the engineering, regulatory, and qualification dimensions of cleanroom design. Drawing on the requirements of EU GMP Annex 1 (2022), ISO 14644-1/2, and FDA aseptic processing guidance, the programme equips professionals with the technical depth and regulatory confidence to design, qualify, and defend cleanroom environments at inspection.
Each session has been architected to deliver standalone value while collectively forming a complete learning pathway — from foundational design principles and airflow visualisation methodology, through HVAC engineering and environmental monitoring, to qualification strategies and inspection readiness.
The series is led by practitioners with hands-on experience in cleanroom design, smoke study execution, and regulatory inspection — ensuring that every module goes beyond theory and delivers tools and frameworks directly applicable in your organisation.
Cross-Series Outcomes:
Speakers
Key points
Explain cleanroom classification under ISO 14644-1/2 and EU GMP Grades A–D and map to FDA expectations
Describe the key design requirements introduced by EU GMP Annex 1 (2022) for aseptic manufacturing zones
Apply unidirectional airflow (UDAF) design principles and pressure cascade strategies in cleanroom layout
Design, execute, and document smoke studies that meet EMA, FDA, and PIC/S regulatory expectations
Understand acceptance criteria for airflow visualisation: first-pass airflow, turbulence at critical surfaces, and dynamic vs. static conditions
Configure HVAC systems for compliant Grade A/B/C/D environments — air change rates, HEPA filtration, and pressure differentials
Build a viable and non-viable environmental monitoring programme with defensible alert and action limits
Navigate IQ/OQ/PQ qualification protocols for cleanroom and HVAC systems and manage re-qualification triggers
Identify common inspection deficiencies in airflow visualisation and cleanroom qualification — and how to avoid them
Who should attend
Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in:
- Cleanroom & Facility Engineers
Airflow Visualisation (Smoke studies) & Cleanroom Compliance in Biopharma
This 4-session webinar series provides a comprehensive, practitioner-led exploration of cleanroom design, airflow visualisation, and qualification requirements under EU GMP Annex 1 (2022), ISO 14644, and FDA aseptic processing guidance.
Past events
4th Freeze-Drying Technology Summit
FAQ
Your questions answered here.
For any event assistance please contact
Stay informed. Stay ahead
Subscribe to our newsletter for exclusive pharma event updates, industry insights, and speaker announcements.