Terminal sterilisation process for filled syringes under an auxiliary pressure

PCT No. PCT/DE97/01671 Sec. 371 Date Feb. 2, 1999 Sec. 102(e) Date Feb. 2, 1999 PCT Filed Aug. 1, 1997 PCT Pub. No. WO98/05366 PCT Pub. Date Feb. 12, 1998A production process for a prefilled, sterile syringe comprising providing a sterilized syringe barrel having sealable proximal and sealable distal ends. The proximal end being opened and the distal end being closed and adapted for coupling with a syringe outlet piece. In accordance with the process, the distal end of the barrel is closed and the barrel is then filled through the proximal end while the proximal end is opened with a fluid medium in the form of a liquid, a solution, a suspension or an emulsion wherein the barrel contains the fluid medium in a portion of the barrel and contains a gaseous medium in another portion of the barrel. After the barrel has been filled, a sterile plug is inserted through the proximal end of the barrel to close the proximal end. After pressing the plug into the barrel, the barrel is vented through a tube extending past the plug so that only the liquid medium is within the barrel. In accordance with one embodiment of the production process, the barrel is filled first through the open proximal end and then subsequently through a tube which extends past the plug.