Particulate Matter

Particulate Matter

Particulate matter testing is a field of analysis that examines how much of the pollutant particles are present in a product, either naturally or from manufacturing processes. Simulated use testing can also show how much particulate matter an item emits during use. With this testing, it is possible to determine the risk a product may pose to a patient and its potential source of particles. Relevant testing standards include EN 45502, ISO 14708, ISO 8536-4, Section 6.1, ANSI/AAMI AT6, and ANSI/AAMI TIR42.

The USP HIAC Royco technique 788 is an automatic particle analysis method that is used to assess injectable solutions. It involves inverting solutions 20 times, letting them degas, and then analyzing them on a liquid particle counter. The size ranges of the particles tested are 10 and 25 m. 

For solutions that cannot be examined with light obscuration, light microscopy is used. This method involves extracting devices with a suitable solvent, such as low particulate water and then filtering the solutions through a membrane filter. Once the membrane filters are dried, the particles are examined under a microscope with a calibrated graticule and a 100X magnification. The size ranges of the particles tested are 10 and 1,000 m.