Verfahren zur terminalen Sterilisierung von befüllten Spritzen

摘要

The invention concerns a method of producing a pre-filled sterile syringe. The syringe comprises a syringe body with a proximal end and a distal end, a syringe-outlet part at the distal end, a seal, a stopper, a fluid medium and a gaseous medium, the fluid medium being a liquid. The method comprises the following steps: preparing the syringe body, seal and stopper which is/are free from germs and/or endotoxins and low in particles; a lubricant is applied; the proximal end is sealed by inserting the stopper into the syringe body; the syringe is filled through the distal end; the syringe outlet part is sealed with the seal; the syringe is sterilized in a sterilizing chamber; the syringe is then packaged and the package container is then sterilized once again.