Cleanroom certification is based on ISO 14644-1, “Classification of air cleanliness by particle concentration” standards. The specifics of the assessment may vary slightly for FDA or EU GMP regulations, but the underlying methodology is standard.
Certification demonstrates that the entire area meets a specific ISO classification by particle concentration. That is, irrespective of the final use of the room, the design and implementation of the filtration system are considered. The international standard means that a cleanroom tested to meet compliance for ISO 5 standards will meet that standard independent of geography and regulatory aspects (i.e.: FDA or EU GMP). This provides a universal standard to show that a cleanroom level has been established.
Particle Measuring Systems’ products, including the Airnet® II Particle Sensor and IsoAir® 310P Aerosol Particle Sensor, comply with new ISO standards set in 2015. The interactive software of the Lasair® III can even step the user through the certification process.
Tomorrow’s blog will discuss the qualification or the process of analyzing risk assessment for the activities in a cleanroom. Or, if you want to learn more now, download this paper on Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom.