Regulatory Open Forum

Dear community,

Is it always considered subvisible particles in injectable vials particles that are smaller than 100um?
What would be the USP and EP limits for subvisible particles?

Kind regards

100 µm - 150 µm size is usually considered to be the size limit between sub-visible and visible particles.
Note that is it valid for isotropic particles - for longitudinal particles (fiber-like), the size limit can go up to 300 µm.
These considerations can be found in USP <1790>.
And in other documents if it is associated to Visual Inspection of other components/assemblies than the classical glass vials / syringes.
Kind regards