1. Field of the Invention
The invention relates to a container with a flexible container wall, in particular a bioreactor or a mixer bag, with a container interior in which a mixer is arranged, the mixer shaft of which is passed at at least one end through the container wall and is driven from the outside.
2. Description of the Related Art
Containers with a flexible wall are increasingly used in particular as flexible disposable containers or mixing bags in the pharmaceutical/biotechnology industry where, in a very wide variety of applications, sterile liquids not only have to be decanted, transported and stored but also mixed.
DE 10 2006 020 813 B3 discloses a disposable bioreactor which is designed as a flexible bag or container. The interior of the flexible container has a mixer, the mixer shaft of which is guided rotatably as an axis of rotation in a bearing arranged in the container wall and is driven by a motor arranged outside the flexible container. In this case, the flexible container is stabilized by a supporting container at least for the mixing.
A drawback of the known flexible container, which has basically proven worthwhile, is that the rigid stirring mechanism thereof or mixer takes up a relatively large amount of space in the empty container and therefore takes up a considerable size when packaged. In addition, in some flexible containers available on the market, the mixer which is connected to the rigid shaft may result in undesirable rubbing in association with defects on the inner wall of the container.
WO 03/012027 A1 furthermore discloses a bioreactor with flexible walls. In this case, the bioreactor is designed as an inflatable or unfoldable apparatus where a container wall surrounding the container interior can be stabilized by an inflatable structure. This known flexible container also has the abovementioned drawbacks.
U.S. Pat. No. 6,494,613 B2 describes a container with a flexible container wall and with a container interior in which a flexible tube which is passed at one end through the container wall is arranged as the mixer shaft. A shaped rod is introduced into the tube from the outside and is driven in a rotating manner in the tube whereas the tube is fixed in the container wall. Drawbacks include not only the low mixing power, which is realized only by means of the mixer shaft, but also the short service life because the high mechanical stresses caused during rotation of the rod mean that the tube rapidly becomes brittle in the region in which it is fastened to the container wall, which leads to contamination of the products being mixed or of the environment.
Therefore, it is the object of the present invention to improve known containers in such a manner that they can be collapsed in the empty state together with the mixer to form a size of packaging which is as small as possible, and can be operated with a high degree of safety.
This object is achieved by a flexible container wall and a container interior in which a mixer is arranged at one end of a hollow mixer shaft that is passed through the container wall and is drivable from the outside. At least part of the mixer shaft projecting into the container interior is designed such that it is foldable and such that it can be stabilized by flowable media which can be introduced from the outside, and/or in that the mixer is designed such that it is hollow, is foldable and can be stabilized by flowable media which can be introduced from the outside. In this case, the cavities of the mixer shaft and of the mixer are connected in a communicating manner.
By means of the foldable design of the mixer shaft and/or of the mixer, the flexible container can be folded to form a relatively small size of pack. If the mixer is designed to be flat, for example in the form of a two-arm blade, the empty container can be correspondingly flat and folded at least once in the longitudinal direction of the shaft and stored in a space-saving manner. Upon use, the container is then unfolded, if appropriate placed into a supporting container, and filled via supply lines with the liquid media to be mixed. For the mixing, the mixer shaft is stabilized from the outside and the outer end thereof which faces away from the mixer is connected or coupled to the mixer drive.
In a preferred embodiment of the invention, the flowable media are gases or curable gels, polymer foams, pastes and resins. Prior to being put into operation, the media are placed in a flowable state, generally under pressure, into the hollow mixer shaft and/or hollow mixer. After curing of the gels, polymer foams, pastes and resins, the device is ready for operation. In the event of gases being introduced, the pressure in the mixer shaft and/or the mixer is set in such a manner that the stiffness of said gases is maintained as a function of the stirring speed and the viscosity of the product being mixed.
According to another preferred embodiment of the invention, the mixer shaft is designed to be inflatable and, for this purpose, has at least one stabilizing chamber which is inflatable from the outside and runs in the longitudinal direction thereof. In the empty, noninflated state, the container can be collapsed to form a small volume, as described, and stored in a space-saving manner. Upon use, the mixer shaft is then inflated by compressed air or another gas being supplied into the at least one stabilizing chamber thereof, for example via a pump, and being brought into the envisaged shape thereof. The container can then be filled via supply lines with the media to be mixed. In principle, as described above, the container may also be filled first and then the mixer shaft stabilized.
According to another preferred embodiment of the invention, the stabilizing chamber is arranged such that it runs helically in the mixer shaft toward the mixer. The stabilizing chamber is preferably coiled in the opposite direction to the direction of rotation of the mixer.
The helical arrangement of the stabilizing chamber considerably increases the stability of the foldable shaft. In this case, coiling counter to the direction of rotation of the shaft has furthermore proven favorable. It is also possible for two consecutively offset, coiled stabilizing chambers to be arranged in the longitudinal direction of the mixer shaft. It is also possible in principle to provide two stabilizing chambers which are arranged radially next to each other and are coiled in an opposed manner on the mixer shaft.
According to another preferred embodiment of the invention, the mixer shaft has at least one stabilizing channel which runs in the longitudinal direction thereof, is fittable from the outside and into which a stabilizing rod can be introduced. In this case, the stabilizing rod can be designed as a relatively rigid metal wire which can be inserted into the stabilizing channel from the outside. The stabilizing channel or the stabilizing channels can be arranged on the mixer shaft both in addition to or instead of the stabilizing chambers.
The stabilizing channels may also be arranged in a coiled manner to increase the stability.
According to another preferred embodiment of the invention, the mixer shaft has, parallel to the longitudinal axis thereof, at least two mutually opposite, parallel guide channels in which two flexible tension wires are guided, said tension wires being fastened by the ends thereof facing the mixer in the region of the mixer-side end of the mixer shaft and the ends thereof which face away from the mixer projecting on the outside out of the mixer and being guided in a sliding manner in the guide channels and being braceable at the drive-side mixer shaft end in order to stabilize the mixer shaft.
In this embodiment, the mixer shaft can be folded with the flexible tension wires released from the bracing position thereof. In order to bring the mixer shaft into the stabilized, extended shape thereof, the two tension wires merely have to be braced outside the container. If appropriate, two further tension wires which can be braced can be arranged offset by 90°. It is also additionally possible, for example, for an inflatable stabilizing chamber to be arranged centrally in the mixer shaft.
According to another preferred embodiment of the invention, the stabilizing chamber is connected to a safety valve. The stabilizing chamber can therefore be reliably prevented from being able to be destroyed if inflated at too high a pressure.
According to another preferred embodiment of the invention, the mixer shaft is formed from a suitable plastic, preferably a polymer.
Further details of the invention emerge from the detailed description below and the attached drawings in which preferred embodiments of the invention are illustrated by way of example.
A container 1 with a flexible container wall 2 essentially comprises a container interior 3 and a mixer 4.
The container 1 which is designed as a disposable bioreactor has the container interior 3, the flexible wall 2 of which, surrounding said container interior, comprises a lateral container wall 5, a container base 6 arranged at the bottom in the vertical direction and a container top 7 arranged at the top in the vertical direction. The mixer 4 is arranged at a lower end 8 of a mixer shaft 9 in the vertical direction. The upper end 10 of the mixer shaft 9 that faces away from the mixer 4 penetrates the container top 7 of the flexible container wall 2. The mixer shaft 9 which projects at the upper end 10 thereof out of the container 1 is connected at the upper end 10 thereof to a drive 11. The mixer shaft 9 is mounted in a sealed but rotatable manner in a bearing 12 of the flexible container wall 2 or, in the example, of the container top 7.
The mixer shaft 9 is formed from a flexible plastic and is foldable together with the flexible container wall 2 when the container interior 3 is empty. At the same time, the mixer shaft 9 is designed such that it can be stabilized in the unfolded interior 3 and when the latter is filled with liquid media 13 such that said mixer shaft, driven by the drive 11, sets the mixer 4 into a rotating mixing movement.
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Number | Date | Country | Kind |
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10 2007 061 664.5 | Dec 2007 | DE | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/EP08/10565 | 12/12/2008 | WO | 00 | 6/2/2010 |