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.
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:
- Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes
- PMS Cleanroom particle counters including portable/mobile and fixed/remote
- Microbial Monitors including portable/mobile, fixed/remote, and single use.
- Data management software from Particle Measuring Systems
Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located.
