Subvisible particle testing addresses regulatory limits for particulate matter in parenteral drugs, ophthalmic solutions, and lipid emulsions.

Particle measurements in ultra-pure water (UPW) systems can take a long time to return to a stable baseline after normal operations are interrupted by an event such as maintenance shutdowns. A ...

Particulate matter found in injectable drugs is measured in the visible and sub-visible ranges. In the sub-visible range, measurements are generally made by liquid particle counter, or by microscopic ...

Patients are administered parenteral drugs usually by means of injections, and therefore these drugs must be free of visible particles. To ensure this, the USP <788> Particulate Matter in Injections ...

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 ...

Optical particle counters (equipment here from Pacific Scientific), now with ISO standard calibrations, determine the condition of hydraulic oils used in injection machines and ensure comparability of ...