Cleanroom Testing and Qualification to ISO 14644-1 & Filters Workshop

Learn about real-world cleanroom testing, qualification, and requalification per ISO 14644-1 and GMP Annex 1. Get an introduction to testing filters with photometers and particle counters, followed by live demonstrations and a case study presentation.  The day will conclude with a panel discussion. Attendees can ask questions of industry experts.

Course outline     Who should attend?     Course materials     Presenters    Next date and location

Course outline

  1. Cleanroom Testing, Qualification, and Requalification
    1. Classification Testing: Per ISO 14644-1 and GMP Annex 1
    2. Pretests required before particle counting
      1. Air Volume and Velocity
      2. Differential Pressure
      3. Temperature and Relative Humidity
      4. Airflow Visualization
      5. Recovery Testing
    3. Containment Leak Testing
    4. Gathering Data for Environmental Monitoring
    5. Requalification Requirements
  2. Filters Workshop Introductions and Live Demonstrations
    1. Introduction to Testing Filters with Photometers
      1. Demonstration: Testing Filters with Photometers
    2. Introduction to Testing Filters with Particle Counters
      1. Demonstration: Testing Filters with Particle Counters
  3. Case Study: Investigation to the Introduction Methods of Aerosolized Oil for HEPA Integrity Testing
  4. Panel Discussion: Wrap-up, Conclusions, and Q&A

Who should attend?

This course is for anyone involved in the cleanroom construction and design phase including start-ups.

Course materials

  • Copy of PowerPoint presentation in course binder

Continuing Education Units: .6 CEUs


Hasim Solmaz, Lighthouse Worldwide Solutions
Anthony Hawkins, ATI
Jason Kelly, Lighthouse Worldwide Solutions
Kyle Mulder, TSS

Next date and location

May 9, 2023
9:00 a.m. - 4:30 p.m. Central TIme
Intercontinental St. Paul Riverfront*
St. Paul, Minnesota
During ESTECH 2023
Click here to view registration information

* Virtual option also available.