Comparative Study of Particulate Contamination from Ampoule and Prefilled Syringe

앰플 및 1회용 주사용기에서의 미립자 혼입에 관한 비교연구

Particulate is the foreign insoluble material in injectable solution inadvertently present in a given product. Considerable efforts have been made to avoid or minimize particulate contamination by pharmaceutical manufacturers during the production of parenteral products. Particulate contamination of the parenteral products can occur mainly during the opening (cutting) the container immediately before clinical use. In this study, particulate contamination generated during the opening process of ampoules (conventional type, 1-point and color-break ampoules) was compared with that of a prefilled injectable container (prefilled syringe). The particles were examined under a microscope after filtration of the total fluids in the containers. Particles having wide range of size distribution were found from all the ampoules tested. The contamination from the I-point ampoule and colorbreak ampoule was much less than from the conventional ampoule. Glass particles generated by cutting the glass-made ampoules seemed a principal source of the particulate contamination. The glass-partiaulte contamination could be improved substantially by replacing the ampoule containers with the prefilled syringe. Prefilled syringe, which can be used without any cutting process. did not generate particulates during the use. Therefore, it was concluded that prefilled syringe is most preferable container for the small volume parenteral (SVP) fluids in terms of particulate contamination.