Airflow Visualisation (Smoke studies) & Cleanroom Compliance in Biopharma

Industry Experts Explore Airflow Visualisation and Cleanroom Compliance at "Airflow Visualisation (Smoke Studies) & Cleanroom Compliance in Biopharma" Webinar

The successful conclusion of Airflow Visualisation (Smoke Studies) & Cleanroom Compliance in Biopharma, a comprehensive four-session webinar series, brought together pharmaceutical and biopharmaceutical professionals to address one of the industry's most critical challenges: ensuring cleanroom performance meets increasingly stringent regulatory expectations.

Designed around the latest requirements of EU GMP Annex 1 (2022), ISO 14644-1/2, and FDA aseptic processing guidance, the programme delivered a practitioner-led journey through cleanroom engineering, airflow visualisation, qualification, and inspection readiness. Participants gained practical insights into designing, qualifying, and defending Grade A and Grade B environments under real operational conditions—not merely through documentation, but through demonstrable performance.

Structured to provide both standalone educational value and a cohesive learning pathway, the series covered:

• Foundational cleanroom design principles
• Airflow visualisation and smoke study methodologies
• HVAC engineering and environmental monitoring
• Risk-based qualification strategies
• Inspection readiness and regulatory expectations

By combining regulatory interpretation with hands-on industry experience, the programme equipped attendees with practical frameworks to strengthen contamination control strategies and prepare for regulatory inspections.

Cross-Series Outcomes

Participants left the series with enhanced capabilities to:

• Build a comprehensive regulatory framework spanning EU GMP Annex 1 (2022), ISO 14644, and FDA aseptic processing guidance.
• Apply practical smoke study protocols and airflow visualisation methodologies that satisfy EMA and FDA inspection requirements.
• Develop risk-based, inspection-ready cleanroom qualification and environmental monitoring programmes adaptable across sterile manufacturing environments.

The event welcomed professionals from pharmaceutical manufacturers, biologics and ATMP developers, CDMOs, CROs, engineering consultancies, and quality and regulatory functions, all seeking to strengthen their approach to contamination control and aseptic processing compliance.

Thank You to Our Speakers

We extend our sincere appreciation to our expert speakers for sharing their knowledge, practical experience, and valuable perspectives throughout the programme:

• Volkmar Balzer – CCI vK GmbH & Co. KG
• Johannes Rauschnabel – Syntegon Technology GmbH
• Varadharaj Vijayakumar – Terumo Pharmaceuticals Services GmbH
• Morgan Polen – Microrite, Inc.

Their expertise transformed complex regulatory and engineering concepts into practical guidance that attendees can apply within their own organisations.

Thank You to Our Sponsors & Partners

This webinar series would not have been possible without the generous support of our sponsors:

• Microrite, Inc.
• Quantum Bioconsulting

Their commitment to advancing education and fostering collaboration across the life sciences sector played an important role in the success of this initiative.

Looking Ahead

The enthusiastic participation and engagement throughout Airflow Visualisation (Smoke Studies) & Cleanroom Compliance in Biopharma demonstrated the industry's strong commitment to improving contamination control, strengthening cleanroom performance, and achieving inspection-ready compliance.

We thank every attendee, speaker, and sponsor for contributing to the success of this event and for helping advance best practices across the global biopharmaceutical manufacturing community.