Japanese–English glossary
Visible particles
Also called visible foreign matter
可視異物kashi ibutsu
Also written ビジブル
Particles or foreign matter large enough to be seen by eye during inspection of injectable products, either from the product and process itself or from outside. Injectables are inspected unit by unit, and the pharmacopoeias require them to be essentially free of visible particles. For protein products, visible proteinaceous particles can form over time from subvisible ones, so control of aggregation earlier in the size range is the practical way to prevent them. Japanese documents also use a shortened loanword for 'visible'.