What are the different types of particle defects in injectable products?

Particle (particulate) defects are solid foreign bodies found inside or on an injectable container. The main types are black particles, white particles, metal particles, glass particles, rubber particles, and particles embedded on the component body.

In pharmaceutical visual inspection, particulate matter is the most safety-critical defect class because a particle injected with a parenteral product can cause serious patient harm. Each particle type points to a different source: metal particles usually come from filling-line equipment and needles; glass particles from vial or ampoule breakage and scoring; rubber particles from stopper or gasket coring; black particles from charred product, carbon, or degraded elastomer; and white particles from excipients, precipitates, or plastic. An embedded particle is one fused into the glass or lodged in the container wall rather than floating freely.

FTI's Knapp challenge sets reproduce each of these types at controlled sizes (100--1000 µm) so inspectors and automated systems can be qualified to detect them reliably under USP <790> and USP <1790>. For particles of unknown origin found in production, FTI's particle characterization service identifies them by SEM-EDX and FTIR.