Sterile formed, filled and sealed flexible container

A port assembly for use with a flexible, multiple-layer film container having a laminated outer surface and a hermetically sealed inner chamber, the port assembly comprising:

• a rigid tubular body having a first and a second open end;
• a integral circumferential flange surrounding the first open end of the tubular body and having a flange face circumferentially sealable to the outer surface of the container;
• a fluid flow fitment at the second open end of the tubular body;
• a removable cover attachable to the fluid flow fitment for closing the second open end of the tubular body;
• and
• a cylindrical penetrator slidably contained within the tubular body and having a hollow beveled end for slidably protruding beyond the circumferential flange so as to pierce the surface of the flexible container and penetrate the hermetically sealed inner chamber of the flexible container and at least one passageway through the penetrator for fluid communication from the penetrated inner chamber of the flexible container to the fluid flow fitment.

A sterile formed, filled and sealed flexible container for a sterile fluid, the container comprising:

• a flexible film sheet having at least an inner film layer and an outer film layer;
• a longitudinally extending saddle line dividing the film sheet into substantially equal first and second portions;
• a fluid sump stretched outwardly from the film sheet and having a longitudinal axis coincident with the saddle line;
• the first portion of the film sheet folded over the saddle line so that the inner layer of the first portion of the film sheet opposes the inner layer of the second portion of the film sheet;
• a continuous peripheral seal between the inner layer of the opposed first and second portions of the film sheet so as to form a hermetically sealed inner chamber between the first and second portions of the film sheet;
• a rigid tubular port having a first and second open end;
• an integral circumferential flange surrounding the first open end of the tubular port, the flange having a contoured face circumferentially sealed to the outer layer of the film sheet along the radiused fluid sump;
• an access fitment at the second open end of the tubular port;
• a removable cover for closing the second open end of the tubular port;
• a penetrator element slidably contained within the tubular port and having a sharp end for slidably protruding beyond the circumferential flange so as to piece the film sheet and penetrate the sealed inner chamber;
• and
• at least one passageway through the penetrator element from the sharp end for fluid communication from the penetrated inner chamber to the access fitment.