Particulate matter test in small volume parenterals: critical aspects in sampling methodology.

The following critical steps of the particulate matter test sampling methodology for small volume parenteral products (SVPs), conduct by light blockage method, were considered: 1) reliability of the small volume aspirator sampler for different sample volumes; 2) particulate matter distribution inside each ampoule in liquid products (8 liquid SVPs tested); 3) influence of the sample preparation method on the evaluation of the final contamination of the sample. Nine liquid SVPs were tested by preparing samples following the three U.S.

Evaluation of official instrumental methods for the determination of particulate matter contamination in large volume parenteral solutions.

The distribution pattern of particle contamination in nine different types of LV parenteral solutions and the possibility of correlating the counts made with two official instruments (Coulter Counter and HIAC) were studied. Two hundred containers of LV parenteral solutions (corresponding to 40 batches) produced in Italy, were sampled. Each bottle was submitted to HIAC and Coulter Counter countings, for particle sizes ranging between 2 and 25 micron.