Medical product including pre-filled product bag

A medical product comprising:

• a bladder comprising adjacent front and rear films secured together by a perimeter seal and defining a sterile chamber comprising at least a first chamber portion and a second chamber portion isolated from the first chamber portion by a peelable seal formed by a bond between adjacent interior surface portions of the front and rear films,
• the peelable seal adapted to be broken to facilitate fluid communication between the first and second chamber portions;
• the second chamber portion comprising bonded portions between the front and rear films to facilitate fluid mixing within the second chamber;
• a filtration device comprising a stem and a filter membrane disposed in line with the stem, the stem extending through the perimeter seal and having an inlet end accessible from outside of the perimeter seal and an outlet end in fluid communication with the sterile chamber, the filter membrane with a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm, wherein the filter membrane has a hollow core with a wall extending around the hollow core and pores residing in the wall;
• and
• a sterile product concentrate disposed in the second chamber portion.

A method of reconstituting a product from concentrate, the method comprising:

• Providing a bladder having a perimeter seal and defining a sterile chamber containing a sterile product concentrate, at least one filtration device comprising a connector, a stem, and a filter membrane, the stem extending through the perimeter seal and having an inlet end accessible from outside of the perimeter seal and an outlet end in fluid communication with the chamber, the filter membrane with a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm, wherein the filter membrane has a hollow core with a wall extending around the hollow core, an open first end, a closed second end, and pores residing in the wall of the fiber;
• introducing a pharmaceutical fluid into the filter membrane through an open outlet end of the connection received within the filter membrane received through the open first end and subsequently into the chamber of the bladder through the filter membrane;
• and
• mixing the pharmaceutical fluid and the product concentrate together in the chamber of the bladder to reconstitute the product.