Participants will learn:

• about HEPA filter performance, handling and storage
• airflow definitions and equations
• how to identify different types and classes of filters and what are the critical distinguishing factors
• how to measure airflow in cleanrooms, clean benches, and HVAC systems
• how to perform airflow visualization
• theory and operation of photometers and particle counters
• how to verify room cleanliness class
• how to repair media and gasket leaks in HEPA filters

Standards Covered:

• ISO 14644-1: Classification of Air Cleanliness
• ISO 14644-2: Specifications for Testing and Monitoring to Prove Continued Compliance
• IEST RP34: HEPA and ULPA Filter Leak Tests
• IEST RP6: Testing Cleanrooms
• IEST RP1: HEPA and ULPA Filters
• IEST RP2: Unidirectional Flow Clean-Air Devices
• FDA CGMP Guide

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

Dan Milholland is the lead instructor. He has worked in the cleanroom testing and verification field since 1975. Dan has served on many IEST committees, including the working group that prepared Federal Standard 209E and ISO 14644-1. He is currently serving as a consultant to the cleanroom industry. Dan Milholland will be joined by David Phillips, Thermo Fisher Scientific; and additional instructors including: David Stuart, Ph.D., The Baker Company; Gene Klingbeil, Filtration Group; and Lewis Exner, Micro-Clean; as well as a representative from Air Techniques.

Tuition is $1395 per person and must be paid in full to guarantee a space in this class. Tuition includes a course manual, lunch each day, a special class dinner, and an Eagleson Institute certificate.

Day 1

• Cleanrooms
  • Overview
  • History
  • Characteristics
• Introduction to HEPA Filters
  • Components
  • Mechanisms of Action
  • Repairing and Replacing
  • Leak Testing
  • Particle Counter
  • Photometer
• Labs
  • Fun with Photometers
  • Bag In/Bag Out
  • Using Photometers for Leak Testing
  • Repairing Media Leaks

Day 2

• Photometers and Aerosol Generators
  • Theory
  • Operation
• Particle Counters
  • Theory
  • Operation
• Particle Counts - Classifying Fairly
  • Particle Count Height
  • Number of Locations
  • Inconsistency Overtime
  • Sample Volume
• Labs
  • Using a Particle Counter to Verify Room Cleanliness Class
  • Scanning a HEPA filter with a Particle Counter
  • Bleed through and Aerosol Generators Airflow Visualization
  • Tips for Leak Testing in Ducts

Day 3

• Principles of Airflow Airflow Visualization
  • Videotape review
  • GMP
  • Aseptic Processing for the FDA
• Labs
  • Videotaping Airflow Visualization
  • Measuring Airflow in Cleanroom
  • Clean Benches
    • Measuring Airflow
    • Filter Installation
    • Gasket Repair
  • Measuring Pressure Drop Across Filters

Day 4

• Review
• Airflow in Cleanrooms
  • Air changes
  • Filter Configuration
  • CFD
• Air Measurements
  • Velocity
  • Volume
  • Pressurization
  • K factor
• Standards Review