QUALITY EVALUATION OF RADIOGRAPHIC CONTRAST-MEDIA IN LARGE-VOLUME PREFILLED SYRINGES AND VIALS

Rationale and Objectives. The authors compared the particle contaminat ions of radiographic contrast media packaged in large-volume prefilled syringes and vials. Materials and Methods. Particle counting was perf ormed for four contrast media packaged in large-volume prefilled syrin ges (iohexol, ioversol, ioversol for angiography, and ioxaglate) and t hree contrast media packaged in vials (iohexol, ioversol, and ioxaglat e). X-ray emission spectrometry was performed to characterize the indi vidual particles. The amount of silicone oil in the syringe was quanti fied with infrared spectrophotometry. Results. The particle contaminat ion in syringes containing ioversol was higher than that in syringes c ontaining iohexol or ioxaglate. Particle contamination in the vials wa s relatively low, except with ioxaglate. X-ray emission spectrometry o f the components of the syringe and vial showed that the source of par ticles was internal material released from the rubber stopper or inner surface. Conclusion. The particle counts for contrast media packaged in syringes and vials varied considerably among the different contrast media and were related to the amount of silicone oil on the inner sur face and rubber piston of the syringe.