Environmental system designers are frequently asked where to position sample points for particle monitoring, whether it is conducted in a clean device (Isolator, RABS, etc.) or a pharmaceutical ...

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 ...

Pharmaceutical products are produced to meet strict standards for effectiveness and quality. Every aspect of quality is assessed, taking into account the risks associated with the method of delivery ...

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 ...

Particle characterization involves analyzing particles based on attributes such as shape, size, surface properties, charge properties, mechanical properties, and microstructure, among others. A wide ...