Particle Counting for ISO 14644 (Pharmaceutical Manufacturing)
The revised ISO 14644-1:2015 has set new cleanroom classification and monitoring standards for cleanroom managers and manufacturers, causing some questions and confusion.
This paper, written by an ISO 14644 expert, 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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