Class Agenda

Day One

What to Do to Certify a Controlled Environment for Biopharma Facilities
The Hierarchy of Regulations and Standards
History of HEPA Filters
Principles of HEPA Filtration
Photometers and Aerosol Generators
Photometric Testing of HEPA Filters
Workshops
- Photometer and Aerosol Generator Set Up
- Scanning
- HEPA Filter Repair and Handling

Day Two

Airflow Basics
Measuring Airflow in Cleanrooms
Room to Room Differential Pressure
Room Air Exchange Rate
Workshops
- Measuring Airflow in Cleanrooms
- Workshop B

Day Three

Discrete Particle Counter vs. Photometer
Room Classification with Discrete Particle Counter
Airflow Pattern Visualization
Workshops
- Airflow Visualization
- Particle Counter Lab
- How to Prepare a Course of Action Based on the Guidance Documents
Discussion: Can You Believe This Actually Happened?! Situations to Avoid

Testing of HEPA Filtered Systems and Pharmaceutical Cleanrooms

October 1-3, 2024 | Sanford, Maine

This three-day class will use lecture, hands-on workshops and group activities to provide the knowledge needed to test HEPA filters and the support systems in regulated cleanrooms and controlled environments per the FDA’s Aseptic Guidelines, and relevant ISO and US standards.

Who Is This Course For?

Validation, Quality Assurance and Contamination Control Personnel, Facility Engineers, Maintenance Personnel, Cleanroom Certifiers, and Architects and Engineers involved in cleanroom design.

Course Instructors

Lewis Exner, Director of Field Operations, Controlled Environment Consulting, LLC.
Todd Urton, Senior Training and Technical Manager, Technical Safety Services
Shane Morris, Owner, Champion Air Testing

Course Tuition

Tuition of $1995 must be paid in full to guarantee a space in the class. Tuition includes: course manual, lunch each day, an Eagleson Institute certificate and a special class reception and dinner with plenty of time to network with peers and instructors.