Changes in the classification standard, ISO 14644-1:2015, will have an impact on both the number of sample points needed to classify and on the quality and maintenance of the instruments needed to ...

Today’s standards define airborne particle monitoring in units of particles per cubic meter (particles/m 3). These standards tend to require sampling an entire cubic meter (1 m 3) to establish an ...

eracount xs is the most compact and fastest field particle counter. With the push of a button, the laser-based analyzer measures and displays ISO 4406 particle size channels ≥4 µm(c), ≥6 µm(c), and ...

This article outlines guidelines for the testing of high pressure gases utilized in cleanrooms according to the cleanliness limits stated in the FDA cGMP guidelines, the ISO 14644-1 cleanroom ...

Both the USA cGMP 1 and EU GMP 2 dictate that cleanroom classification must be carried out according to ISO 14644-1. The version of this ISO standard released in 1999 4 was rewritten by a group of ...

To guarantee the safety and efficacy of products manufactured in cleanroom environments, organizations such as International Organization for Standardization (ISO) and regulatory bodies such as the ...