The Foundations of Contamination Control using Essential Cleanroom Standards ISO 14644-1 and ISO 14644-2

ISO 14644-1 and 14644-2 are the cornerstone international cleanroom standards, essential for all contamination control professionals. This course covers the nuts and bolts of ISO 14644-1:2015, Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness by particle concentration, and ISO 14644-2: 2015, Cleanrooms and associated controlled environments—Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. This full-day course also includes a brief overview of the entire ISO 14644 series to help you become familiar with the breadth of this essential International Standards Series.

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



Course outline

  • Overview of ISO Technical Committee 209
  • Overview of the ISO 14644 Series
  • ISO/TC 209 Working Group 1
  • Analysis of ISO 14644-
    • Definitions
    • Classification
    • Table for air cleanliness classes
    • Differences from FED-STD-209E
    • Demonstrations of compliance
    • Annexes
    • Sampling location comparisons
  • Analysis of ISO 14644-2
    • Scope
    • Definitions
    • Demonstration of continued compliance
    • Principle
    • Testing for continued compliance
    • Monitoring
    • Documentation
    • Annexes

 

Who should attend?

You need information on the history of ISO 14644 Standards and the requirements of ISO 14644-1 and ISO 14644-2 because:

  • You test cleanrooms
  • Your cleanroom needs to be compliant with ISO 14644 Standards
  • You design and install cleanrooms that need to be compliant with ISO 14644 Standards
  • You specify or operate a cleanroom

Course materials

  • Copy of ISO 14644-1:2015, and ISO 14644-2:2015
  • Copy of PowerPoint presentation


Continuing Education Units: .6 CEUs



Instructor

Hasim Solmaz

Hasim Solmaz is General Manager of Lighthouse Worldwide Solutions EMEA Operations. Hasim’s focus is on cleanroom design and management concepts, environmental
monitoring systems, pharmaceutical manifacturing and regulatory concerns. Hasim is a founding chair of Cleanroom Technologies Society of Turkey, head of delegates in ISO TC209
“Cleanrooms and associated controlled environments” and expert in ISO TC209 “Cleanrooms and associated controlled environments” Working Group 3 “Cleanroom Test Methods”. Recently appointed as honorary chair of ICCCS, The International Confederation of Contamination Control Societies which is an international community for national society on cleanrooms and contamination control.

Hasim is an active member of International Society for Pharmaceutical Engineering (ISPE), Institute of Environmental Sciences and Technology (IEST) and Parenteral Drug Association (PDA). He holds a Bachelor of Science degree with high honors in Atmospheric Science and Meteorological Engineering from Istanbul Technical University.

 

Next date and location

May 6, 2024
In-person at ESTECH 2024
Planet Hollywood, Las Vegas, Nevada
Click here for details

This course is also available virtually.