ABSTRACT
Particulate matter (PM) associated with pharmaceutical systems is in large part unwanted contamination in sterile products for which there are compendial guideline methods and according limits. Other products are certainly impacted by unwanted particles and appearance failures, which may be studied in a similar manner. PM is a broad term to include many varieties of conditions, sizes, and associations of particles in the product fluid. In an ideal state, a single particle is a single type of material in solid form present in the pharmaceutical product and detected by a human observer or an electronic detection/counting device. Generally, if detected by human vision, it is visible. The common types of PM encountered in pharmaceutical injections, primarily from earlier and less refined manufacturing designs that allowed too much of the natural world to creep into the liquid fill, were first addressed by Australian researchers Garvan and Gunner.
