Method of producing prefilled sterile plastic syringes.

摘要

There is disclosed a process for producing sterilized prefilled plastic syringes avoiding plastic deformation and distortion. The plastic barrels are subjected to repeated water jet washing steps to remove contaminants and depyrogenate the barrels. Tip seals and pistons are subjected to removal of debris and pyrogens and destruction of microbial contaminants. After the tip is assembled on the nozzle of the barrel, the barrel is filled with contrast media through its open end, after which the piston is assembled in the open end to seal the syringe and its contents. The assembled and sealed syringe is then subjected to autoclaving to sterilize the syringe and its contents, without deformation of the plastic syringe or a loss of integrity to the closed media/syringe system.