Appendix XIII B. Particulate Contamination: Visible Particles

(Ph. Eur. method 2.9.20)

Particulate contamination of injections and infusions consists of extraneous, mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions.

The test is intended to provide a simple procedure for the visual assessment of the quality of parenteral solutions as regards visible particles. Other validated methods may be used.

APPARATUS

The apparatus (see Figure 2.9.20.-1) consists of a viewing station comprising:

— a matt black panel of appropriate size held in a vertical position,

— a non-glare white panel of appropriate size held in a vertical position next to the black panel,

— an adjustable lampholder fitted with a suitable, shaded, white-light source and with a suitable light diffuser (a viewing illuminator containing two 13 W fluorescent tubes, each 525 mm in length, is suitable). The intensity of illumination at the viewing point is maintained between 2000 lux and 3750 lux, although higher values are preferable for coloured glass and plastic containers.

Figure 2.9.20.-1. –Apparatus for visible particles

METHOD

Remove any adherent labels from the container and wash and dry the outside. Gently swirl or invert the container, ensuring that air bubbles are not introduced, and observe for about 5 s in front of the white panel. Repeat the procedure in front of the black panel. Record the presence of any particles.