The invention relates to a device for minimizing oxygen content for containers to be filled, such as ampules, which are preferably produced according to a blow, fill and seal process and which can be provided by means of a supply device with a displacement medium which displaces the oxygen out of the container before sealing it, the supply device having at least one medium supply channel by means of which the displacement medium can be supplied to the respective container and which is at least partially a component of a filling device by means of which the respective container can be filled, the filling device having a filling mandrel with a filling channel, separated from which the respective medium supply channel runs, and the filling mandrel still having at least one other medium transport channel.
EP 1 343 693 B1 discloses a device for producing and filling containers such as ampules, with at least one mold which has movable mold walls and into which at least one tube of plasticized plastic material can be extruded, whose mold parts can be closed in order to weld the leading end of the tube to form a container bottom by welding edges which are located on the mold parts, with a device for producing a pressure gradient which acts on the tube and widens it for ejecting the container on the mold walls, with a movable separating element which can be moved to form a fill opening by cutting the tube above the mold between a withdrawn base position and a working position, and with a transfer device for moving the mold into the filling position for filling the container through the fill opening, a sterile barrier being provided in a positional arrangement and with dimensions such that it is located in the working position of the separating element above the path of motion of the mold which leads into the fill position, the sterile barrier being a plate which is heated to a germ-killing temperature and which can be moved together with a blade which is used as a separating element. Furthermore the European patent discloses a production method for these containers using the device.
When highly sensitive products are produced, for example in the form of special pharmaceuticals, in which international standards for aseptic packaging must be satisfied, the mold, when it has been moved into the filling position, is located under a so-called sterile filling chamber (ASR) in which sterile air flows over the open fill opening of the container and forms effective protection against the penetration of germs until after completion of the filling process movable head jaws of the mold are closed in order to form the desired head closure of the container by a combined vacuum welding process. The sterile barrier prevents foreign bodies from being able to fall into the open fill opening after the tube is severed before the mold has reached the sterile filling chamber (ASR) and furthermore the sterile barrier during this segment of the process also prevents objectionable influx of germs into the fill opening.
But it has been shown that oxygen-sensitive products including high quality pharmaceuticals which added to container products such as ampules in this way then come into contact with a residual oxygen content in the respective container which leads to damage processes especially in the form of oxidation on the added product; this is accompanied by a distinct reduction of possible storage life. Accordingly, for sensitive products a remaining portion of oxygen in the head space of the container which is kept free of the added product of less than 0.5%, preferably of less than 0.2%, is currently required. These requirements are not adequately satisfied either by the aforementioned sterile barrier device or other known production methods together with devices as are shown, for example, by U.S. Pat. No. 5,961,039 or JP-A-4147824.
This ultimately also applies to devices which in order to minimize the oxygen content for containers to be filled, such as ampules, use a displacement medium which, supplied by means of a supply device, displaces the oxygen from the container before it is sealed. Thus JP 2004-042961 AA discloses a solution of a device in which by means of a supply device which is moved over the free container opening of a filled container inert gas as a displacement medium is blown out in the direction of the container opening in order in this way to reduce the oxygen content by displacement out of the container opening.
DE 1 566 547 A discloses a process for filling and sealing ampules as containers in which a filling mandrel with a filling channel for supply of the product to be placed in the container is encompassed in a concentric arrangement by a medium supply channel which surrounded to the outside by one wall part of the supply device is used to supply a displacement medium in the form of an inert gas in order in this way to minimize the oxygen content within the container.
U.S. Pat. No. 6,112,780 A discloses a generic device for minimizing the oxygen content for containers to be filled, such as bottle products, with a supply device which has different medium transport channels in a concentric arrangement, the innermost channel in turn forming the filling channel of a filling mandrel. A medium supply channel which encompasses the filling channel for the displacement medium in the form of an inert gas is in turn surrounded by a medium drain channel which is used to remove the displacement medium together with the oxygen from the respective container (3-tube solution). In one especially preferred embodiment of the known device for minimizing the oxygen content, there is still another medium supply channel in a concentric arrangement between the first medium supply channel and the outermost medium drain channel in order in this way to move the displacement medium pulsed into the interior of the container with the added product (4-tube design). In another alternative configuration of the known solution, space permitting, in the respective container, it is also proposed that the indicated medium channels be provided separated from one another and next to one another in a line within the device. The minimization device which is geometrically large in each version of the solution in the area of medium supply also leads to large volumes of oxygen to be displaced so that this known solution is not suitable either for producing the required setpoints of 0.2 to 0.5% residual oxygen content in the free head area of the respective container.
Proceeding from this prior art, the object of the invention is therefore to further improve the known devices such that during the production process they enable minimization of the oxygen content to the required setpoints of 0.2 to 0.5% residual oxygen content in the free head area of the respective container. This object is achieved with a device with the features of claim 1 in its entirety.
In that, as specified in the characterizing part of claim 1, the filling channel with its free cross section is guided in a ring channel region of the filling mandrel, which region is larger in cross section and in that within the ring channel region the filling channel separates medium-tight the respective medium supply channel from the respective medium transport channel, a very small device for minimizing the oxygen content for containers to be filled is devised so that less “dead space” is formed which could fill with air which then can no longer be displaced in order to achieve in this way the low residual oxygen contents of 0.2 to 0.5% of the oxygen which is otherwise present. The displacement medium, preferably consisting of a noble gas such as argon or an inert gas such a nitrogen gas can be flushed by means of the supply device into the respective container such that it almost completely displaces the residual oxygen from the container before it is sealed so that the described oxidation processes which adversely affect the extremely oxygen-sensitive products stored in the container are avoided; this benefits a long storage capacity of the overall product.
In one preferred embodiment of the device according to the invention the medium transport channel is used to remove the displacement medium together with the oxygen from the respective container, or to supply the displacement medium to the respective container. In the former case therefore the displacement medium is supplied by way of the respective medium supply channel and the medium transport channel is made as a medium drain channel in order to remove the displacement medium with the oxygen from the container opening. In the latter case the medium transport channel is used as another medium supply channel so that in spite of the supply situation which is kept small by the installation space a maximum of displacement medium to be supplied is achieved in order in this way to minimize the oxygen content in an extremely efficient manner. In the case in which the displacement medium is supplied both by way of the respective medium supply channel and also by way of the respective medium transport channel, the medium together with the atmospheric oxygen to be displaced can also be displaced outside of the supply device out of the container interior directly into the exterior.
Minimization of the required installation space is gained when the filling channel, the medium supply channel and the medium transport channel which are located medium-tight separately from one another within the ring channel region of the filling mandrel have the same input and/or output directions. The resulting parallel arrangement of the channels also allows streamlined transport of the individual media.
In one especially preferred embodiment of the device according to the invention, it is provided that the ring channel region of the filling mandrel viewed in cross section is made circular and the wall of the filling mandrel bordering the filling channel forms an oval which is reduced in cross section in one transverse direction and which in the longitudinal direction pushes against the inside wall of the circular ring channel region in order to separate from one another the thus formed sickle-shaped free cross sections of the medium supply channel and the medium transport channel. In this way all medium channels are combined centrally in the supply device in an especially space-saving manner.
The indicated displacement results can be still further improved when another medium channel, preferably made as a medium supply channel, is in a concentric arrangement to the wall of the filling mandrel and encompassing it, the other medium channel being chambered to the outside by another wall of the supply device. In addition or alternatively, it can furthermore be preferably provided that the surrounding region of the container to be filled at the time be provided at least partially with a blocking medium by means of another supply device. In this way the oxygen content in the ambient region of the respective container opening can also be reduced; this contributes to improving the result of minimization of oxygen content.
Other advantageous configurations of the device according to the invention are the subject matter of the other dependent claims.
The device according to the invention is detailed below using two exemplary embodiments as shown in the drawings which are schematic and not to scale.
In the filling position shown in
The molding tools 5, 13 shown in
In order to displace the thus remaining residual oxygen out of the cavity 19, there is a supply device designated as a whole as 20 which supplies the displacement medium to the cavity 19 which displaces the oxygen out of the container 12 before sealing it. The displacement medium is preferably an inert gas such as nitrogen gas. The supply device 20 has a medium supply channel 22 for the nitrogen gas which in this respect can be supplied to the cavity 19 of the respective container 12. This medium supply channel 22 is shown in
As
Furthermore, the indicated filling mandrel 17 has another medium transport channel 34 as a drain channel which in turn is reproduced only in cross section in
By way of a vacuum device which is not shown, this removal can be further supported, and the negative pressure to be set, however, should be chosen such that the product added to the container 12 is not unintentionally exhausted from it. The amounts of displacement medium which are to be supplied, such as nitrogen gas, are also oriented to the free head cross sections of the container 12 together with the free volumes of oxygen within the cavity 19.
Otherwise the filling channel 28 as well as the medium supply channel 22 and the medium drain channel 34 run parallel to one another but separately from one another within the elongated filling mandrel 17. This separation of media is apparent especially from the cross section as shown in
As
The other embodiment as shown in
A further medium channel 45 according to the embodiment as shown in
With the device according to the invention, the residual oxygen in the container products can be pressurized to less than 0.5% and lower into the range of 0.2% and less.
Number | Date | Country | Kind |
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10 2007 015 078.6 | Mar 2007 | DE | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/EP2008/002399 | 3/27/2008 | WO | 00 | 9/10/2009 |