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Cleanroom Certification: More Than a Pass/Fail
Tuesday, December 16, 2025 | 1:00 PM - 2:00 PM EST
Webinar Overview
This webinar will address airflow visualization studies (AVS), also known as smoke studies, in cleanrooms. Additionally, important international standards, industry guidance, and regulatory observations and concerns will be addressed.
Learning Objectives
- Examine how airflow visualization studies are defined and evaluated in international cleanroom standards, industry guidance, and regulatory expectations from the U.S. FDA and global cGMP frameworks.
- Identify key technical and practical considerations for planning and conducting effective smoke studies.
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Analyze real-world case studies illustrating the consequences of poorly executed airflow visualization studies and their impact on regulatory compliance and organizational performance.
Speakers
 Morgan Polen
Morgan Polen is a subject-matter expert in contamination control, airflow visualization, and particle monitoring in cleanrooms. Morgan has over 40 Years of industry experience working in cleanrooms in all industries. Morgan’s Technical Leadership:
• Member of International Disk Drive and Equipment Materials Association (IDEMA) Standards Committee
• Member of U.S. Technical Advisory Group to ISO Technical Committee 209 (international cleanroom standards i.e., ISO 14644 Cleanrooms and Associated Controlled Environments) • Member of ASTM Subcommittee E55.06 Working Group “Guide for Critical Airflow Visualization”
• Former Board member of the Institute of Environmental Sciences and Technology (IEST) Morgan has been instrumental in drafting and editing international cleanroom standards, contamination control guidelines and best practices.
He has extensive experience working on cleanroom projects in over 40 countries and is a valuable resource for contamination control in critical environments for the electronics, aerospace, and healthcare industries. As a key member of Microrite’s Expert Contamination Control team, Morgan is instrumental in developing proactive contamination control strategies through pragmatic risk assessment, particle testing, and airflow visualization. Morgan’s broad experience in troubleshooting contamination issues has helped companies with remediation following FDA 483s and warning letters.
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