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The revised ISO 14644-1:2015 has set new cleanroom classification and monitoring standards for cleanroom managers and manufacturers, causing some questions and confusion.

ISO 14644-1:2015 Cleanroom monitoring and classification solutions

ISO 14644 expert, Daniele Pandolfi (of Particle Measuring Systems) has written a brief but comprehensive paper that includes:

  • a summary of the new cleanroom classification standards, highlighting the changes
  • an explanation of how it affects your cleanroom monitoring
  • ISO 14644-1 cleanroom classification table
  • Cleanroom counts per ISO 14644-1
  • Cleanroom particle count limits

This paper highlights the major changes in the new ISO 14644-1 compared to the previous version, as well as the possible impact on the Pharmaceutical EU GMP Annex 1 and FDA Aseptic Processing Guideline and includes information on ISO 14644-2 and ISO 21501-4. 

Vignette du Lasair III 5100

Interested in learning more?
Complete the form to get the full paper.

Learn about the latest Annex 1 approach for Cleanroom classification and monitoring.

Read about ISO 14644-2 Cleanroom monitoring requirements.

Particle Measuring Systems (PMS) has complete cleanroom classification and monitoring solutions for you including:

Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located.

  • Author

    Daniele Pandolfi

    Global Product Line Manager, Aerosol, Particle Measuring Systems

    Daniele Pandolfi is the Global Product Line Manager, Aerosol in Particle Measuring Systems’ Life Science Division. He has over eleven years’ experience in particle counter instrumentation and cleanroom contamination control, focusing on strong customer relationships. He has helped many cleanroom users solve their cGMP issues. Mr. Pandolfi has been responsible for the EMEA Service Department, and a member of the Global Life Science organization since 2015.