Particulate contamination in ampoules

Abstract

Abstract The particulate contamination in 19 formulations of solutions in ampoules supplied by eight South African manufacturers, thirty-three batches in all, was analysed using a HIAC PC 320 light blockage particle analyser linked to a CMB 60 sensor. Results showed that the level of contamination was generally low and that, where comparisons could be made, manufacturers both of the ampoules and the solutions maintained similarly high standards. Problems in this field appeared to be related to the formulation or the quality of the raw material.