ISO 14644-1:2015 Revisions Summary for Life Sciences

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 expert, Daniele Pandolfi 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. 

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

Read about ISO 14644-2 Cleanroom monitoring requirements.

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