Airborne Particle Counters in Cleanroom Operations: Design, Application, and related Regulatory Issues

Airborne Particle Counters in Cleanroom Operations: Design, Application, and Related Regulatory Issues


Particulate levels in the air need to be controlled for many tasks in various manufacturing industries, in academic research, and in healthcare settings.The advancing interest in nanoscale materials has created a renewed focus on the control of particles below 0.1 microns in addition to the concern for control of airborne levels of particles above 0.1 microns. This course will provide a brief introduction to the design of airborne particle counters, describing both light-scattering and condensation nucleus instruments. There will be a detailed review of how these instruments are employed in various industries in terms of practical use and relevant regulations and standards. In particular, the impact of the revision of the ISO 14644-1 and -2 will be discussed, including the stricter calibration demands of the ISO 21501-4 standard. Practical aspects of implementing a monitoring strategy will be reviewed, including the often challenging need to set effective alarm limits.

Course outline     Who should attend?     Course materials     Instructor


Course outline

1. Particle Counter Design and Typical Use
  • Design and comparison of light-scattering and Condensation Nucleus Counter (CNC) instruments
  • Typical styles of use and best practices in electronics, semiconductor, hard disk drive industries; aerospace; life sciences, including pharmaceutical, biotechnology, medical device industries; and compounding pharmacies
  • Impact of implementation of the ISO 21501-4 Calibration Standard for Light-scattering Particle Counters
2. Design of sampling strategies
  • Classification (Revision of ISO 14644-1; EU GMP Annex 1; FDA, WHO and PIC/s Guidances)
  • Monitoring (Revision of ISO 14644-2)
  • Alarm strategies (Alert and Action; Lo/Lo-Lo, Hi, Hi-Hi; etc.)
  • Data management – moving the focus from simple data acquisition to distributed information in a paperless environment
Who should attend?

This course will be valuable to both existing users of particle counting instruments and to those who are managing cleanrooms and clean zones where the control and measurement of airborne particulate levels are required. The course will also be a good background introduction for anyone who is contemplating initiating airborne particulate control, even in the new sub-micron nanoscale levels.
  • Environmental Monitoring (EM) technicians and program managers
  • Cleanroom certifiers
  • Plant managers
  • Production managers
  • Metrology engineers and program managers
  • QA/QC managers for cleanroom-based operations
  • Cleanroom design engineers

Course materials

  • Copy of PowerPoint presentation in a course binder
  • Certificate of course attendance with completion of CEUs
Continuing Education Units: .6 CEUs

Instructor


 Joe Gecsey