Particulate Contamination in Single-Dose Parenteral Antibiotics in Iran

In order to ensure the safety of parenterals, international pharmacopoeias andnational standards have set up stringent guidelines and standards. particulatecontamination is a potential health risk caused by intravenous injection of particleslarge enough to potentially clog the small arteries. particles could be produced throughmanufacturing and packaging or even dispensing of the pharmaceuticals. thenature of the particles are varied and could be of drug itself, packaging debris, rubber,plastic, cotton, fiber and glass particles, which might be produced during thebreakage of an ampoule. in this study, some of the small volume parenteralsavailable in iranian drug market have been investigated for the presence of particles.although, most of the tested samples passed national standard tests for particulatecontamination of small volume parenterals, 40% of the samples were rejectedusing the same protocols. therefore, it appears that particulate contamination ofparenterals creates an additional source of risk for patients who receive thesemedications, intravenously.