Air Flow Visualization (Smoke Studies) Technology and Techniques: A Practical Tool for Contamination Control in the 21st Century
Understanding airflow patterns in cleanrooms and controlled environments is an important aspect of contamination control. Because cleanrooms are complex environments, factors such as; cleanroom design, layout, and integration of equipment, may create areas with undesirable airflow patterns. Additionally, during opertaions; personnnel, equipment, and material flow can interrupt HEPA filters airflow patterns or create undesirable airflow that can act as a channel or reservoir for contamination. As air is transparent, the actual or physics contamination control effect of cleanroom airflow can only be effectively understood when it is visually represented. Frequently referenced in FDA warning letters and form 483 observations, airflow visualization studies are an expected test by international pharmaceutical inspection authorities and mentioned in FDA, EMA, PIC/S, WHO, and USP regulations and guidance documents. In this class you will learn what an airflow visualization test is; how to test and what is needed; and standards regulations and guideance of airflow visualization. Also included will be live airflow visualization testing.
Course outline Who should attend? Course materials Instructor Next date and location
Course Outline
- Introduction
- What is airflow visualization (smoke studies)?
- Cleanroom airflow
- Standards regulations and guidance for airflow visualization
- International cGMP (Annex 1) and smoke studies
- Technology
- Jetting effect (ejection velocity)
- Poorly conducted smoke studies
- How bad smoke studies lead to EM data integrity
- Examples of poor airflow
- Examples of good airflow
- Cleanroom airflow visualization testing demonstration
Who should attend?
Information coming soon
Course materials
- Copy of presentation in PDF format
- .6 CEUs
Instructor
Morgan Polen
Morgan Polen is the principal consultant for Microrite. Morgan brings 30 years’ experience working in cleanrooms and is a subject matter expert in particle monitoring. He has been involved with various cleanroom projects working in over 40 countries. With hands on experience in projects ranging from cleanroom design, construction, validation, monitoring program development, particle counter design, and product management for cleanroom related products and systems. Addressing monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical, and food and beverage manufacturing. He has lectured on particle monitoring and contamination control in North America, South America, Europe, Asia, and the Middle East.
Next date and location
September 19, 2024
9 a.m. - 4:30 p.m. central time
University of Tennessee Health Science Center - Plough Center
Memphis, TN
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