Unit for the Sterile Filling of a Final Basic Container with Contents Designed for the Biopharmaceutical Field

Patent metadata

Field	Value
Publication number	US-2020407085-A1
Application number	US-202016948282-A
Country	US
Kind code	A1
Filing date	Sep 11, 2020
Priority date	Feb 10, 2010
Publication date	Dec 31, 2020
Grant date	—

Abstract

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.

First claim

1 . A sterile filling unit of at least one final basic container with contents that can be distributed in a fluid form and that are originally located in a source container in a sterile manner, the sterile filling unit comprising:
a sterile chamber that has at least one sterile entry port and/or outlet; communication means, distribution means, and at least one sterile fluid filling element, forming, when all assembled, a sterile fluid transfer and filling line that has an intake and at least one outlet, such that for a filling stage, the sterile fluid transfer and filling line passes through a wall of the sterile chamber in a sterile manner, with the intake being located outside of the sterile chamber and in sterile fluid communication with the source container, with the at least one filling element, at the outlet, being located inside the sterile chamber and positioned to be able to be operating, with one or more so-called internal means and elements being located substantially inside the sterile chamber and one or more so-called external means and elements being located substantially outside of the sterile chamber, including a so-called engaging communication pipe segment that is able to pass through the wall of the sterile chamber in a sterile manner and whose downstream end part is able to be put into sterile communication with the end part that is upstream from the internal means and elements, with the internal means and elements having overall dimensions that allow passage through a door of the sterile chamber and being of the disposable type for the filling in question; and means that can introduce the disposable internal means and elements that, in a stage prior to the filling stage, were located outside of the sterile chamber, into an interior of the sterile chamber in a sterile manner.

2 . The sterile filling unit according to claim 1 , wherein the sterile filling unit comprises p filling elements for n final containers, with p being greater than or equal to n.

3 . The sterile filling unit according to claim 1 , wherein the sterile filling unit comprises p filing elements for n final containers, with p being less than or equal to n.

4 . The sterile filling unit according to claim 1 , wherein the sterile filling unit also comprises at least one other functional means or element that is designed to be integrated into the transfer and filling line, such as a filtering means, a buffer storage means, or a connection means, with said other functional element being either disposable for the filling in question and located inside the sterile chamber, or located outside of the sterile chamber.

5 . The sterile filling unit according to claim 1 , wherein the internal means and elements comprise at least communication means, distribution means and at least one filling element.

6 . The sterile filling unit according to claim 5 , wherein the internal means and elements comprise at least one other disposable internal functional means or element.

7 . The sterile filling unit according to claim 1 , wherein the sterile filling unit also includes at least one sterile individual unit of internal means and elements comprising a sterile pocket of internal means and elements, having a wall that limits a sterile inner space and that is equipped with an opening and an associated door that is complementary to a door of the sterile chamber that can make possible, with the individual unit being mated to the sterile chamber and the doors being in the open state, a sterile transfer of these internal means and elements between the inner space of the pocket and the interior of the sterile chamber, with these internal means and elements in the sterile state being placed in the inner space of the pocket of internal means and elements.

8 . The sterile filling unit according to claim 1 , wherein the sterile filling unit also includes at least one sterile individual unit of external means and elements comprising a sterile pocket of external means and elements having a wall that limits a sterile inner space and that is equipped with an opening and an associated door that is complementary to a door of the sterile chamber that can allow, with the individual unit being mated to the sterile chamber and the doors being in the open state, a sterile transfer of these external means and elements between the inner space of the pocket and the interior of the sterile chamber, with these external means and elements in the sterile state being placed in the inner space of the pocket of internal means and elements.

9 . The sterile filling unit according to claim 1 , wherein the means and elements that constitute the transfer and filling line include at least one external means or element with overall dimensions not allowing passage through a door of the sterile chamber.

10 . The sterile filling unit according to claim 1 , wherein before the introduction into the sterile chamber of internal means and elements and at least one internal functional means or element, the different means and elements that are designed to be part of the transfer and filling line inside the sterile chamber are all assembled with one another.

11 . The sterile filling unit according to claim 1 , wherein before the introduction into the sterile chamber of internal means and elements and at least one internal functional means or elements, the different means and elements that are designed to be part of the transfer and filing line inside the sterile chamber are all disassembled from one another.

12 . The sterile filling unit according to claim 1 , wherein before the introduction into the sterile chamber of internal means and elements and at least one internal functional means or elements, some of the different means and elements that are designed to be part of the transfer and filing line inside the sterile chamber are assembled with one another and others are disassembled from one another.

13 . The sterile filling unit according to claim 1 , wherein before the filling stage, the different means and elements that are designed to be part of the transfer and filling line outside of the sterile chamber are either all assembled with one another, or all disassembled from one another, or some are assembled with one another and others are disassembled from one another.

14 . The sterile filing unit according to claim 1 , wherein the end part that is downstream from the part of the transfer and filling line outside of the sterile chamber and the end part that is upstream from the part of the transfer and filling line inside the sterile chamber, which are assembled for the filling stage, are either assembled with one another, or disassembled from one another before the filing stage.

15 . The sterile filling unit according to claim 1 , wherein the sterile filling unit also comprises means for introducing empty final containers into the interior of the sterile chamber and means for evacuating the filled final containers from the interior of the sterile chamber.

16 . The sterile filling unit according to claim 1 , wherein the one or more so-called external means and elements is of the disposable type for the filling in question.

17 . An individual unit designed for the production of a sterile filling unit according to claim 1 , wherein there is provided an individual unit that comprises:
a sterile pocket of internal means and elements having a wall that limits a sterile inner space and that is equipped with an opening and an associated door that is complementary to a door of the sterile chamber that can make possible, with the individual unit being mated to the s

Assignees

• Sartorius Stedim Fmt Sas

Inventors

• Gay Isabelle
• Mendyk Nicolas

Classifications

• B65B31/02

  Filling, closing, or filling and closing, containers {or wrappers} in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas · CPC title

• B65B3/003 Primary

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title