Unit for the sterile filling of a final basic container with contents designed for the biopharmaceutical field
A sterile filling unit, of a basic container with contents that can be distributed in a fluid form and that is originally located in a source container in a sterile manner, includes a sterile chamber with at least one sterile entry port and/or outlet; a sterile fluid transfer and filling line with an intake and an outlet, such that for a filling stage the line passes through the wall of the sterile chamber in a sterile manner, with the intake located outside of the sterile chamber in sterile fluid communication with the source container, with the filling element at the outlet located inside the sterile chamber and positioned to be operating; and a unit that can introduce the disposable internal elements that, in a stage prior to the filling stage, were located outside of the sterile chamber, into the interior of the sterile chamber in a sterile manner.
1. An individual unit to be used in a sterile filling unit comprising a chamber and a sterile fluid transfer and filling line, the sterile filling unit being configurable to fill, in a sterile manner, a final basic container in the sterile chamber, with contents that can be distributed in a fluid form through the sterile fluid transfer and filling line, from a source container outside the sterile chamber, the sterile chamber having at least one sterile port and/or outlet, the sterile port and/or outlet having a first door providing an opening, the first door being made in a wall of the sterile chamber, the individual unit comprising:
a sterile pocket having a wall that limits a sterile inner space and that is equipped with an opening and an associated second door, the second door being complementary to the first door and being structurally mate-able to the first door of the sterile chamber so as to allow, the first and second doors being open, a sterile transfer of the contents of the sterile pocket to an interior of the chamber;
a disposable buffer storage bag located in the sterile inner space of the sterile pocket, the buffer storage bag having overall dimensions that allow passage of the buffer storage bag through the first and second doors.
2. The individual unit according to claim 1 , further comprising in the sterile pocket at least one among pipes, tubes and hoses, having overall dimensions that allow passage through the first and second doors.
3. The individual unit according to claim 2 , wherein the at least one among pipes, tubes and hoses are disposable.
4. The individual unit according to claim 1 , further comprising in the sterile pocket at least one among open or closed containers, vials, syringes, flasks, bottles, and pockets, having overall dimensions that allow passage through the first and second doors.
5. The individual unit according to claim 4 , wherein the at least one among open or closed containers, vials, syringes, flasks, bottles, and pockets, are disposable.
6. The individual unit according to claim 1 , further comprising in the sterile pocket at least a filter, having overall dimensions that allow passage through the first and second doors.
7. The individual unit according to claim 6 , wherein the filter is disposable.
8. The individual unit according to claim 1 in combination with the sterile filling unit comprising the chamber and the sterile fluid transfer and filling line, the sterile filling unit being configurable to fill, in a sterile manner, the final basic container in the sterile chamber, with contents that can be distributed in a fluid form through the sterile fluid transfer and filling line, from the source container outside the sterile chamber, the sterile chamber having the at least one sterile port and/or outlet, the sterile port and/or outlet having the first door providing an opening, the first door being made in the wall of the sterile chamber.
9. The combination of claim 8 ,
wherein, the sterile fluid transfer and filling line has an intake that is adapted to be in sterile fluid communication with the source container, the sterile fluid transfer and filling line having at least one outlet, the sterile fluid transfer and filling line comprising an engaging communication pipe segment comprising
i) a first end, located outside the sterile pocket, and
ii) a second end, located inside the sterile pocket, the second end having a downstream end part at an outlet of the engaging communication pipe segment,
wherein elements of the sterile fluid transfer and filling line located internal to the sterile inner space of the sterile pocket, including the buffer storage bag and the downstream end part of the engaging communication pipe segment, have overall dimensions that allow passage through the second door of the sterile chamber when the sterile pocket is structurally mated to the sterile chamber so that, with the first and second doors being in the open state, the sterile pocket provides for a sterile transfer of the elements of the sterile fluid transfer and filling line located internal to the sterile inner space of the sterile pocket, including the buffer storage bag and the downstream end part of the engaging communication pipe segment, between the sterile inner space of the sterile pocket and an interior of the sterile chamber,
wherein, for a filling stage, the elements of the sterile fluid transfer and filling line located internal to the sterile inner space of the sterile pocket, including the buffer storage bag and the downstream end part of the engaging communication pipe segment, are adapted to pass, via the first and second doors, through the wall of the sterile chamber in a sterile manner, with
i) the intake of the sterile fluid transfer and filling line being located outside of the sterile chamber and adapted to be in sterile fluid communication with the source container,
ii) the buffer storage bag being located inside the sterile chamber upstream of the at least one outlet of the sterile fluid transfer and filling line, and
iii) the at least one outlet of the sterile fluid transfer and filling line being located inside the sterile chamber and positioned to fill the final basic container with the contents, and
wherein the sterile pocket and the elements of the sterile fluid transfer and filling line located internal to the sterile inner space of the sterile pocket are of the disposable type for the filling in question.
10. The individual unit according to claim 1 , further comprising at least a part of the sterile fluid transfer and filling line inside the sterile pocket.
11. The individual unit according to claim 10 , wherein said part of the sterile fluid transfer and filling line is disposable.
12. The individual unit according to claim 10 , wherein the part of the fluid transfer and filling line comprise a first end, outside the sterile pocket, and a second end, inside the sterile pocket.
13. The individual unit according to claim 10 , wherein the part of the fluid transfer and filling line comprise a first end, outside the sterile pocket, and a second end, inside the sterile pocket.