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 Cleanroom Classification & Monitoring](https://techmaster.com.vn/wp-content/uploads/2022/11/14644-1.png)
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.
![Lasair Pro ISO Stamp](https://techmaster.com.vn/wp-content/uploads/2022/11/Lasair-Pro-ISO-Stamp-400x400-1.jpeg)
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.
![Sr. Daniele Pandolfi](https://techmaster.com.vn/wp-content/uploads/2022/11/Daniele-Pandolfi.jpg)
AUTHOR
Sr. Daniele Pandolfi
Daniele Pandolfi é o Gerente Global de Linha de Produtos de Software/Sistemas/Serviços da Particle Monitoring Systems, Inc. Com mais de 11 anos de experiência em contador de partículas e controle de contaminação em salas limpas, ele se concentra em construir e manter relacionamentos fortes com os clientes. Ele ajudou muitos usuários de salas limpas a resolver seus problemas de cGMP.