Abstract: A medical product includes a bladder, a filtration device, and a sterile product concentrate. The bladder has a perimeter seal and defining a sterile chamber. The filtration device includes a stem and a filter membrane disposed in line with the stem. The stem extends through the perimeter seal and has an inlet end accessible from outside of the perimeter seal and an outlet end in fluid communication with the sterile chamber. The filter membrane can have a nominal pore size in a range of approximately 0.1 ?m to approximately 0.5 ?m, wherein the filter membrane is shaped as a hollow fiber with a wall and pores residing in the wall of the fiber. The sterile product concentrate is disposed in the sterile chamber and adapted to be reconstituted by the introduction of a pharmaceutical fluid into the chamber through the filtration device.

Abstract: A sterile product bag includes a bladder, a stem, a filter, and a vial adaptor. The bladder has a perimeter seal and defining a sterile chamber. The stem extends through the perimeter seal and has an inlet end outside of the perimeter seal and an outlet end in fluid communication with the chamber. The filter is disposed in line with the stem and has a filter membrane with a nominal pore size in a range of approximately 0.1 ?m to approximately 0.5 ?m. The filter membrane is shaped as a hollow fiber with a wall and pores residing in the wall of the fiber. The vial adaptor includes a sterile hollow cannula, a sheath, and a peelable closure. The cannula is in fluid communication with the chamber of the bladder. The sheath is disposed outside of the bladder and connected to the hollow cannula. The sheath includes an interior cavity into which the hollow cannula extends. The peelable closure extends across an opening of the sheath to seal the interior cavity.

Abstract: A medical product includes a bladder, a filtration device, and a sterile product concentrate. The bladder has a perimeter seal and defining a sterile chamber. The filtration device includes a stem and a filter membrane disposed in line with the stem. The stem extends through the perimeter seal and has an inlet end accessible from outside of the perimeter seal and an outlet end in fluid communication with the sterile chamber. The filter membrane can have a nominal pore size in a range of approximately 0.1 ?m to approximately 0.5 ?m, wherein the filter membrane is shaped as a hollow fiber with a wall and pores residing in the wall of the fiber. The sterile product concentrate is disposed in the sterile chamber and adapted to be reconstituted by the introduction of a pharmaceutical fluid into the chamber through the filtration device.