FAQ - Pharmaceutical/Life Sciences Particle Counting

APSS 200 Particle Counter

Question
What is the non pathogen particle size limitation in IV injectable solution?

Answer

EP and USP both describe the tests as either Visible or sub-visible.

Visible is typically taken as >100 um and you are allow none (0 - zero) of these present, the phrase is 'essentially free' which takes on many different statistical vagaries, but if you stay at zero it is safe.

The second limit is sub-visible and the tests are for 10 and 25 um. Different limits apply for both sizes and also depend on the method of introduction. For more information, please read Particle Counting in Injectables. For a particle counting solution, read about our APSS-200 particle counter.