Small liquid container

Abstract

The present invention relates to a small-volume liquid container (1) for supplying a liquid medium, in particular a biological medium, into a bioprocessing device, in particular a bioreactor, the liquid container (1) providing a storage volume (2) for the liquid medium, the liquid container (1) having two shape-stable container parts (6, 7) movable relative to one another between an initial position and an end position, and an outlet connection (8) for discharging the liquid medium. It is proposed that the liquid container (1) has shape-deformable delimiting means (9) which delimit the storage volume (2) at least in a predetermined section, the delimiting means being connected to the shape-stable container parts (6, 7) in such a way that a relative movement of the shape-stable container parts (6, 7) relative to one another, which results in a change in the volume of the storage volume (2), is accompanied by a shape change of the delimiting means (9).

Description

[Technical field]

[0001] The invention relates to a small-volume liquid container for supplying a liquid medium into a bioprocessing technical device, in particular a bioreactor, of the type described in the preamble of claim 1, to a packaging assembly comprising a package and a liquid container packaged in a sterile manner in the package according to claim 13, and to the use of such a sterilely packaged liquid container and / or such a packaging assembly according to claim 14.

[0002] Bioprocessing equipment in this case means, in a very general sense, equipment that can carry out or support a biotechnical process. Here, only by way of example, a bioreactor is mentioned, in which microorganisms or tissue cells are cultivated under predefined conditions. Such equipment usually has a container in which the material provided for the biotechnical process, for example the microorganisms or tissue cells on the one hand and the biological reaction medium resulting from the corresponding culture medium on the other hand, is accommodated so that the respective biotechnical method step, for example fermentation or cultivation, can be carried out.

[0003] An example of such a bioreactor is, on the one hand, a production bioreactor, i.e. a relatively large bioreactor of production scale, with a working volume of, for example, several hundred or several thousand liters, for the industrial production of microbial or cellular products, in particular biopharmaceuticals. Such a bioreactor forms a fermentation broth as product, which is usually further processed in so-called downstream processes to obtain products from cells or culture supernatants. Another example is a laboratory bioreactor, i.e. a relatively small bioreactor of laboratory scale, with a working volume of, for example, less than 10 liters. Such laboratory bioreactors are used, for example, for the production of ATMPs (Advanced Therapy Medical Products) and / or for carrying out cell proliferation, which can generate a sufficient number of cells, in particular tissue cells or microbial cells, for each intended use. One example of use for this is the proliferation of human cells, for example T cells (T lymphocytes), which are taken from a patient and then expanded ex vivo and then reinfused into the patient.

[0004] In particular, but also in principle in production bioreactors, in the production of ATMPs in laboratory bioreactors, it is important to add the respective liquid media, for example biological, to each bioreactor as accurately and precisely as possible. Since many ATMPs cannot be sterile filtered or cannot be finally filtered, the production of such pharmaceutical products is carried out aseptically in clean rooms of the appropriate clean room class. That is, since the addition of liquid media to a bioreactor or the transfer of liquid media between two culture vessels and / or bioreactors essentially poses a risk of contamination, such handling steps are usually carried out in clean rooms of clean room class A (GMP guideline annex 1) or ISO 5 (ISO 14544-1). However, the production of pharmaceutical products in such clean rooms is very costly due to the high monitoring requirements, the laborious dressing procedures, etc.

[0005] For this reason, especially in the field of ATMP production, there is a demand for closed systems for culturing or growing cells, in which cleanrooms of lower cleanroom classes can be used, for example cleanrooms of cleanroom class D (GMP guideline annex 1) or ISO8 (ISO 14644-1). In this case, however, there is the problem of adding liquid media to such closed systems as simply as possible. Indeed, various small-volume liquid containers are known, i.e. liquid containers with a small capacity, for example up to 30 ml, such as syringes or vials. However, the transfer of liquid media from such liquid containers to closed systems often requires the multiple use of sterile connectors, sterile filters, etc., which further increases the effort and costs.

[0006] The problem underlying the present invention is to construct and improve a small volume liquid container such that the addition of liquid medium into a closed system is simplified for the end user.

[0007] The object is achieved in a small volume liquid container, in particular for supplying a biological liquid medium, according to the preamble of claim 1 by the features set forth in the characterizing part of claim 1.

[0008] The basic idea is to provide a small volume liquid container, which allows a precise amount of liquid medium, in particular biological, to be transferred into a bioprocessing equipment, in particular into a bioreactor, without the user having to fill the liquid container in a clean room and / or using sterile connectors, sterile filters, etc. This is achieved by configuring the proposed liquid container in such a way that the liquid medium to be added can be filled simply and already at the manufacturer's side, in order to provide the end user with a pre-filled liquid container for the respective biotechnical process, for example ATMP production. For this purpose, the proposed liquid container, in addition to the two shape-stable container parts, which can push the medium out of the storage volume by a relative movement with respect to each other, additionally has an element that defines a storage volume for the medium, which element changes its shape by the relative movement of the container parts. This element, which will be referred to as shape-changeable defining means in the following, forms a preferably flexible container, which can be simply filled aseptically by the manufacturer with the exact amount of liquid medium required, and which can then be simply emptied by the user by the relative movement of the two shape-stable container parts.

[0009] Filling by the manufacturer, which is possible with the proposed solution, has the advantage, firstly, that a very large number of units can be produced automatically under industrial conditions, which significantly reduces the risk of contamination compared to manual filling. Furthermore, this allows a particularly precise filling of precisely defined amounts of liquid medium into liquid containers, which ensures that the same amount is always filled, even in the case of large numbers. Finally, the large number of units correspondingly reduces the filling effort compared to manual filling. Thus, significant advantages already arise from the filling of the individual volumes alone.

[0010] In addition, however, the addition of the liquid medium from the liquid container into the closed system is also significantly improved. That is to say, as mentioned above, on the one hand, it is guaranteed that each liquid container always contains exactly the predefined amount of liquid medium. On the other hand, it is guaranteed that, if several liquid containers are used in a series of biotechnical processes, they all contain exactly the same filling amount. Finally, a particularly high level of sterility is also guaranteed, since the receiving volume is filled under sterile conditions and, particularly preferably, the form-stable container part is also prepared by the manufacturer and is likewise provided to the end user in a sterile manner. The proposed liquid container can therefore be provided to the end user in a sterile package, preferably as a unit already filled exactly with the liquid medium. This unit is preferably provided to the user already filled and sterile, so that the user only has to ensure a sterile connection when transferring the liquid medium from the liquid container to the closed system.

[0011] Apart from the above mentioned advantages, the proposed deformable delimiting means also reduces the subsequent disposal effort, since certain biological media may fundamentally pose a danger to humans and the environment. To avoid this, in this case, in the proposed liquid container, the delimiting means can simply be separated from the form-stable container part and disposed of separately, for example by incineration. The form-stable container part that has not come into contact with the biological media can be reused after sterilization or other inactivation techniques.

[0012] In particular, it is proposed that the liquid container has a shape-changeable delimiting means, which defines the storage volume at least in a certain section, and which is connected to the shape-stable container parts in such a way that a relative movement of the shape-stable container parts relative to one another, which causes a volume change of the storage volume, is accompanied by a shape change of the delimiting means. In this case, shape change means that at least two sections of the delimiting means, each of which defines a storage volume, change their position relative to one another, in particular are moved closer to one another, based on the relative movement of the two shape-stable container parts. In the scope of the shape change, both sections of the delimiting means which change their position can be folded closer to one another, or, if they are already arranged beforehand in the form of folds, for example in the case of a bellows, in the scope of the shape change, the intermediate space between these sections of the delimiting means, which is filled with the medium, can be reduced. That is to say, the shape change is in particular not accompanied by an elastic deformation of the material of the delimiting means, or in any case not accompanied by a significant elastic deformation.

[0013] In a particularly preferred configuration according to claim 2, the delimiting means at least substantially by itself defines the receiving volume. In this case, "substantially" means that the delimiting means may be provided with an opening, in particular a discharge opening, which can be closed by an additional element, for example an extension such as a hose or a small tube, up until the time of supplying the liquid medium, so that in this case the additional element also forms part of the definition of the receiving volume. However, it is also conceivable in principle that the delimiting means completely defines the receiving volume and in any case initially has no openings, and that only in the course of supplying the liquid medium a discharge opening is formed, for example at the intended break point.

[0014] Claim 3 defines a particularly preferred configuration of the delimiting means, in particular when the delimiting means delimits, at least substantially alone, the storage volume.

[0015] Claims 4 and 5 describe particularly advantageous possibilities for the arrangement of the defining means relative to the form-stable container part.

[0016] Claims 6 to 8 relate to particularly advantageous possibilities for the cooperation and configuration of the form-stable container parts.

[0017] Claims 9 and 10 provide for particularly preferred configurations of the liquid container, which allow the supply and possibly filling of the liquid medium, i.e. the defining means and / or the form-stable container part can form the discharge connection and possibly also the filling connection.

[0018] According to a particularly preferred feature of claim 11, the storage volume of the proposed liquid container is already filled with the liquid medium, in particular by the manufacturer.

[0019] Claim 12 defines a protrusion on one or both of the form-stable container parts which, in the end positions of the form-stable container parts, protrudes into a space defined laterally by the material of the delimiting means. This space, also called dead space, necessarily remains in the end positions, since the material of the delimiting means, e.g. the folded layers of a bellows, occupies a certain volume in the end positions and cannot be compressed completely flat. In order to leave as little liquid medium as possible in this remaining space, during a relative movement of the form-stable container parts relative to one another, which causes a volumetric change of the containment volume, the protrusion penetrates into the remaining space and displaces, at least for the most part, substantially completely, the liquid medium present therein.

[0020] According to the teaching according to claim 13, which has an independent meaning, a packaging assembly is claimed per se, comprising a package and a liquid container according to the proposal, packaged in a sterile manner within said package. Given the fact that the packaging assembly according to the proposal comprises a liquid container according to the proposal, reference may be made to all the descriptions of the liquid container in relation to the first teaching.

[0021] According to the further teaching according to claim 14, which likewise has an independent meaning, the use of the proposed liquid container and / or the proposed packaging assembly, which are aseptically packaged, for adding in particular biological liquid media into a bioprocessing technical device, in particular into a bioreactor, is claimed. In view of the fact that the proposed use relates to the use of the proposed liquid container and / or the proposed packaging assembly, reference may be made to all the descriptions of the liquid container and the packaging assembly with regard to the first and second teachings.

[0022] It turns out that the proposed packaging assembly and the proposed use allow the liquid container to be supplied with a liquid medium in a particularly simple manner and without significant contamination risks to closed systems, in particular bioreactors, by providing the liquid container to the end user already in a sterile state. Particularly preferably, the proposed liquid container is also already filled in this state, as already mentioned.

[0023] In a particularly preferred configuration according to claim 15, individual or all components of the liquid container according to the proposal are preferably formed as single-use components, which components are preferably made from a plastic material.

[0024] The invention will now be explained in more detail with reference to the drawings, which show merely exemplary embodiments. [Brief description of the drawings]

[0025] [Figure 1] 1A-1C are perspective views of a proposed small volume liquid container a) during use, b) before use, and c) after use. [Diagram 2] FIG. 2 is a side view of the proposed liquid container of FIG. 1 packaged in a sterile manner. [Diagram 3] 2A and 2B are a perspective view and an exploded view, respectively, of the proposed liquid container of FIG. 1, and FIG. 2C is a view showing a variation of FIG. [Figure 4] 2A-2C are cross-sectional views of the proposed liquid container of FIG. 1 a) before use and b) after use. [Diagram 5] 1A is a perspective view showing a liquid container according to a proposed second embodiment in a state before use, FIG. 1B is a side view showing the liquid container in a state before use, and FIG. 1C is a side view showing the liquid container in a state after use. [Figure 6] 13A is a perspective view showing a liquid container according to a proposed third embodiment in a state before use, FIG. 13B is a side view showing the liquid container in a state before use, and FIG. 13C is a side view showing the liquid container in a state after use.

[0026] The proposed small volume liquid container 1, shown in various exemplary embodiments in Figs. 1 to 6, is used to feed a biological liquid medium, prefilled by the manufacturer, into a bioprocessing technical device, in particular into a bioreactor which forms a closed system or is integrated into a closed system. The bioreactor, which is not shown here for the sake of clarity, is configured, for example, as a laboratory bioreactor, i.e. as opposed to a production bioreactor, has a relatively small working volume (maximum usable filling volume) of up to 10 liters. Such a bioreactor is preferably used in this case for the implementation of a biotechnical process which serves for the production of medicinal products for novel therapeutics (ATMPs). For example, the biotechnical process may be a cell proliferation process for T-cells. In any case, a biological reaction medium is provided in the bioreactor, which in particular comprises tissue cells or microbial cells as well as a culture medium. In this case, the liquid medium has to be added aseptically and in precise doses to the closed system.

[0027] For this purpose, in particular, a proposed liquid container 1 is provided, which provides a storage volume 2 for the liquid medium, which is already filled in a predefined amount by the manufacturer under sterile conditions in the storage volume 2, with the otherwise also sterile liquid container 1 then being packaged aseptically. In this sterile packaged and prefilled state, the proposed liquid container 1 is then provided to the end user. FIG. 2 shows, as an example of this, a packaging assembly 3 with a package 4 and the proposed liquid container 1 packaged aseptically in this package. The liquid container 1, as shown in FIG. 2, is already completely preassembled and is in this case preferably configured as a single-use unit 5, i.e. as a unit 5 whose entire components are single-use components (disposable components). In the case of corresponding exchange of the single-use unit 5, the risk of cross-contamination is significantly reduced.

[0028] The proposed liquid container 1 furthermore has two dimensionally stable container parts 6, 7 which are movable relative to one another between an initial position and an end position and an outlet connection 8 for discharging the liquid medium, as shown in particular in figures 3 to 6. The initial position means, in particular in figures 4 a), 5 b) and 6 b), the position in which the receiving volume 2 has a maximum size or is filled with a predefined amount of liquid medium for supplying to a bioprocessing device. The end position means, correspondingly, the position in which the receiving volume 2 has a minimum size or a predefined amount of liquid medium has been discharged from the receiving volume 2, as shown in particular in figures 4 b), 5 c) and 6 c).

[0029] What is important here is that the proposed liquid container 1 has a shape-changeable defining means 9 which defines the storage volume 2 at least in a predetermined section, and which is connected to the shape-stable container parts 6, 7 in such a way that a relative movement of the shape-stable container parts 6, 7 relative to one another, which results in a volumetric change of the storage volume 2, is accompanied by a shape change of the defining means 9.

[0030] That is, the delimiting means 9 is changed in shape by displacing the container part 6 relative to the container part 7, in this case by applying a manual force, as shown collectively in Fig. 4 a) and b), Fig. 5 b) and c), or Fig. 6 b) and c), respectively, so that in this case the container part 6 is preferably moved towards the container part 7. As a direct result of the corresponding change in shape of the delimiting means 9, a change in the size of the receiving volume 2, i.e. in this case a reduction in the size of the receiving volume 2, occurs. This allows the liquid medium to be drawn off from the receiving volume 2, and thus from the proposed liquid container 1, via the outlet connection 8. Since the proposed liquid container 1 is already filled with a predefined amount of liquid medium by the manufacturer and is packaged aseptically, the addition of the liquid medium to the bioprocessing equipment, in this case a bioreactor, is extremely precise. Furthermore, the end user does not have to fill the small volume liquid container 1 on site himself, so that the risk of contamination of the liquid medium is significantly reduced. Only when transferring the liquid medium from the liquid container 1 to a closed system does the end user need to ensure a sterile connection. Such a sterile connection can be made, for example, via a sterile connector that connects the liquid container 1 or a container-side hose, which will be described in more detail below, in a sterile and fluid-tight manner to a bioprocessing equipment or to a device-side hose. Alternatively, such a container-side hose, which is initially sealed, can be connected in a fluid-tight manner to a corresponding device-side or reactor-side hose, which is also initially sealed, in a sterile welding process.

[0031] In this case, the delimiting means 9 preferably defines the receiving volume 2 at least substantially alone. Only the extension 10, which will be described in more detail below and which is connected to the liquid container 1 and / or the delimiting means 9 via the discharge connection 8, is in this case also part of the delimiting of the receiving volume 2. That is to say, the receiving volume 2 in this case preferably extends inside the delimiting means 9 and inside the extension 10. In principle, however, in an alternative configuration not shown here, it is also conceivable that the receiving volume 2 is at least almost completely defined by the delimiting means 9 together with one or both container parts 6, 7. However, it is preferred if the delimiting means 9 completely or in any case substantially completely forms the receiving volume 2, since this allows the delimiting means 9 to be filled and disposed of independently of the form-stable container parts 6, 7. The container parts 6, 7 can thus be guided together with the delimiting means after filling of the delimiting means 9, in which case the delimiting means 9 is preferably arranged between the container parts 6, 7. After provision of the liquid medium, the defining means 9 can be separated from the container parts 6,7 if desired, and the container parts 6,7 can be reused after discarding the defining means 9.

[0032] 1 to 4, the delimiting means 9 is a bellows 11, in this case preferably a bellows. Due to the above-mentioned relative movement between the container parts 6, 7, the bellows 11 or bellows is in this case compressed in the direction of the discharge connection 8, in particular in accordance with the accordion principle, so that the liquid medium flows out via the discharge connection 8.

[0033] As shown diagrammatically in Fig. 3 c), in a preferred configuration of the liquid container 1, the upper, shape-stable container part 6 can in this case be provided with a protrusion 18 which, in the end position of the container parts 6, 7, protrudes into the space defined laterally by the material of the delimiting means 9, in this case the bellows folds. In this case "latently" means in a direction transverse to the direction in which the container parts move relative to one another. The protrusion 18, which in the starting position faces the deformable delimiting means 9 and / or the receiving volume 2, is in particular materially connected to the container part 6 or is formed integrally with this container part. That is to say, during the relative movement of the container parts 6, 7 relative to one another, which causes a volume change of the receiving volume 2, the protrusion 18 penetrates into the remaining space (dead space) and displaces, at least for the most part, substantially completely, the liquid medium present therein.

[0034] In the embodiment according to Fig. 5 as well, a bellows 11 is provided as the delimiting means 9, which is compressed via the container parts 6, 7 in order to draw off the liquid medium. However, in this case, due to the above-mentioned relative movement between the container parts 6, 7, the bellows 11 is not compressed towards the discharge connection 8 but in the direction around the discharge connection 8. The bellows 11 together with the shape-stable container parts 6, 7 are thus constructed in this case according to the bellows principle, i.e. in the initial position, the bellows 11 is thicker on the side facing away from the discharge connection 8 than on the side facing the discharge connection 8, and in the end position, both sides are approximately the same thickness. However, it is basically also conceivable, particularly in the embodiment according to Fig. 5, to provide as the delimiting means 9 simply a diaphragm, which tightly connects the container parts 6, 7 to one another.

[0035] As shown diagrammatically in FIG. 5 b), again in a preferred configuration of the liquid container 1, at least one form-stable container part 6, 7, in this case both the upper form-stable container part 6 and the lower form-stable container part 7, can be provided with a protrusion 18, which protrudes in the end position of the container parts 6, 7 into a space that is laterally defined by the material of the delimiting means 9, in this case the bellows fold. Again, "latently" means in a direction transverse to the direction in which the container parts move relative to one another. In this case, the above-mentioned space is laterally defined only on the side of the material of the delimiting means 9, in this case the bellows fold. The protrusion 18, which likewise faces the deformable delimiting means 9 and / or the receiving volume 2 in the starting position, is in particular material-connected to the respective container part 6, 7 or is formed integrally with said container part. That is to say, in this case, during a relative movement of the container parts 6, 7 relative to one another, which causes a volumetric change of the receiving volume 2, both projections 18 penetrate into the remaining space (dead space) and displace at least a large part of the liquid medium present therein, essentially completely. It should be noted that in this case, only one projection 18 may be provided, for example provided only on the container part 6.

[0036] In the embodiment of Figure 6, the defining means 9 is a tube 12 which is squeezed by the relative movement of the container parts 6, 7 relative to one another in order to deliver the liquid medium. In this case too, the bellows 11 is compressed by the above-mentioned relative movement between the container parts 6, 7 in a direction around the discharge connection 8, rather than towards it.

[0037] In this case, although not essential, in principle, also in a preferred configuration of the liquid container 1, at least one shape-stable container part 6, 7 may be provided with a protrusion (not shown) which, at the end position of the container part 6, 7, protrudes into the space defined laterally by the material of the defining means 9.

[0038] The delimiting means 9, i.e. in this case preferably the bellows 11 or the tube 12, is in this embodiment removably, in particular form-tightly, attached to at least one of the form-stable container parts 6, 7 and / or between both form-stable container parts 6, 7. This facilitates the separate filling of the receiving volume 2 or the delimiting means 9 and their subsequent disposal. In principle, however, in an alternative configuration, not shown here, it is also conceivable to connect the delimiting means 9 rigidly, i.e. no longer removable without destruction, in particular material-tightly, to at least one of the container parts 6, 7, preferably to both container parts 6, 7.

[0039] In the first embodiment as shown in FIG. 4, the two form-stable container parts 6, 7 are linearly movable relative to one another. They then preferably form a cylinder-piston arrangement 13, in which the upper container part 6 in FIG. 4 forms a piston 13a and the lower container part 7 forms a cylinder 13b in which the piston 13a is linearly movable. In contrast, in the embodiment of FIGS. 5 and 6, the form-stable container parts 6, 7 are pivotable relative to one another. In the embodiment of FIG. 5, at least one of the form-stable container parts 6, 7, or in this case preferably both, is formed in a plate-like shape. "Plate-like" means that the container parts have substantially the same thickness over their entire extension and extend substantially along one plane. In the embodiment of FIG. 6, at least one of the form-stable container parts 6, 7 is formed in a shell-like shape. "Shell-like" means in this case that each container part 6, 7 defines a receiving space in which a delimiting means 9, which in the case of FIG. 6 is a tube 12, can be fitted. Basically, in the proposed liquid container 1, as in the embodiment according to Figures 5 and 6, it is preferred that in any case the side of at least one of the container parts 6, 7, and preferably both container parts 6, 7, facing the defining means 9 and / or the storage volume 2, is substantially flat in order to form an optimal abutment surface for abutting against the defining means 9.

[0040] It is furthermore preferred if in the proposed liquid container 1, in the end positions as shown in figures 4b), 5c) and 6c), the form-stable container part 6 is held form-lockingly in the direction of the start position to the other form-stable container part 7. By way of example only, mention is made for this purpose of a locking element, which is shown in this case only for the embodiment according to figure 1, but which can also be provided in the other embodiments.

[0041] In this case, preferably, as shown in Fig. 4b), one of the container parts, in this case the lower container part 7, has one or more locking projections 14a and the respective other container part, in this case the upper container part 6, has a corresponding element 14b which cooperates with it in a locking manner. When the form-stable container parts 6, 7 are then moved from the start position (Fig. 4a)) to the end position (Fig. 4b), the corresponding element 14b is guided to pass along the respective locking projection 14a, so that a locking connection 14 is formed in the end position. Such a locking connection 14 has the advantage that after the supply of the liquid medium, there is no risk of the medium being sucked back into the receiving volume 2, in particular due to a possible elastic return deformation of the delimiting means 9.

[0042] 4 further shows a fastening element 15, in this case an axial fastening element 15, which prevents the container parts 6, 7 from being separated from one another in the initial position. For this purpose, a locking projection 14a serves again here, which cooperates in a form-locking manner with a further corresponding element 15a.

[0043] As further shown in Fig. 3, in the first exemplary embodiment shown here the discharge connection 8 is formed in the delimiting means 9, in this case in the bellows 11. In this case, preferably, the delimiting means 9 or the bellows 11 is also additionally provided with a filling connection 16, in particular for filling the receiving volume 2 with a liquid medium by the manufacturer. In the exemplary embodiment in Figs. 5 and 6 the discharge connection 8 is also formed in the delimiting means 9. However, in this case no additional filling connection is provided. Additionally or alternatively the discharge connection 8 can also be provided in one of the form-stable container parts 6, 7.

[0044] In the first embodiment, each discharge connection 8 is also connected to the filling connection 16, in this case preferably with a hose 17a, 17b or a small tube forming the above-mentioned extension 10. In this case, via the hose 17a, 17b or small tube, the liquid medium can be drawn off from the receiving volume 2 or introduced into the receiving volume by the manufacturer. The end of the hose 17a, 17b or small tube, respectively, facing away from the liquid container 1 is in this case preferably sealed, in particular welded, by the manufacturer. For the supply of the liquid medium, this seal is removed beforehand, for example within the scope of the above-mentioned sterile welding process, and each hose 17a, 17b is fluidically connected to another, preferably device-side or reactor-side hose (not shown).

[0045] In a further preferred embodiment, the hoses 17a, 17b are already connected at the manufacturer to a connecting device of a sterile connector, which can be connected in a sterile and fluid-technical manner to a corresponding connecting device which is connected to the hose on the device side or on the reactor side.

[0046] The storage volume 2 is in this case preferably sized such that in the starting position the amount of liquid medium in the storage volume 2 is in this case preferably a maximum filling amount of up to 50 ml, preferably up to 40 ml, more preferably up to 30 ml.

[0047] According to a further teaching having an independent meaning, a packaging assembly 3, shown by way of example in Fig. 2, comprising a package 4 and a proposed liquid container 1 aseptically packaged therein, is claimed as such. As mentioned above, it is preferred in this case if the packaging assembly 3 holds the liquid container 1 already filled. In this respect, reference may be made to all the explanations regarding the proposed liquid container 1.

[0048] In this case, preferably the packaging 4 contains the container parts 6, 7, the delimiting means 9, in particular the bellows 11, and the extension 10 in the form of a hose 17a, 17b or a small tube, respectively. In an alternative embodiment, not shown here, it is also conceivable that the proposed packaging assembly 3 only has the delimiting means 9, preferably pre-filled, possibly with the extension 10 or the respective hose 17a, 17b or small tube, aseptically packaged in the packaging 4. The form-stable container parts 6, 7 may in this case be packaged aseptically in a separate package or be prepared by the end user.

[0049] According to further teachings which likewise have an independent meaning, the use of the proposed liquid container 1 and / or the proposed packaging assembly 3, which are packaged aseptically, for adding a liquid medium into a bioprocessing technical device, in particular into a bioreactor, is claimed as such. With regard to the claimed uses too, reference may be made to all the descriptions of the proposed liquid container 1 and the proposed packaging assembly 3.

[0050] After removing the liquid container 1 from the packaging 4, the liquid container is connected, in this case via the extension 10 or the respective hose 17a, 17b or small tube, to the respective bioprocessing technological device.

[0051] In a particularly preferred configuration, at least the delimiting means 9, preferably also at least one form-stable container part 6, 7, in particular both form-stable container parts 6, 7, and / or the hose 17a, 17b or the small tube, respectively, are single-use components. Each component, i.e. the delimiting means 9, each form-stable container part 6, 7, and / or each hose 17a, 17b or each small tube, is at least partially, preferably at least substantially, made of a plastic material. The delimiting means 9 is preferably formed from a plastic film. Silicone materials and / or polymeric materials are particularly suitable as plastic materials for the individual components. Examples thereof are PE (polyethylene), PP (polypropylene), PTFE (polytetrafluoroethylene), PBT (polybutylene terephthalate), PSU (polysulfone), PESU (polyethersulfone), PC (polycarbonate).

Claims

1. A small volume container (1) for supplying a liquid medium into a bioprocessing technical device, said small volume container (1) providing a receiving volume (2) for said liquid medium, the liquid container (1) has two shape-stable container parts (6, 7) movable relative to one another between a start position and a end position and a discharge connection (8) for discharging the liquid medium, The small volume liquid container (1) has shape-changeable delimiting means (9) for delimiting the storage volume (2) at least in a predetermined section, the delimiting means being connected to the shape-stable container parts (6, 7) in such a way that a relative movement of the shape-stable container parts (6, 7) relative to one another, which causes a volumetric change of the storage volume (2), is accompanied by a shape change of the delimiting means (9), The small-volume liquid container (1) is characterized in that, in the end position, one of the shape-stable container parts (6) is form-lockingly held to the other shape-stable container part (7) so as not to move in the direction of the start position.

2. 2. The small volume liquid container (1) according to claim 1, wherein the defining means (9) alone defines the storage volume (2) substantially completely, or the defining means (9) together with at least one of the shape-stable container parts (6, 7) defines at least substantially the storage volume (2).

3. 3. The container (1) according to claim 1 or 2, wherein the defining means (9) is a bellows (11), a tube (12) or a diaphragm.

4. 4. The container (1) according to any one of the preceding claims, wherein the delimiting means (9) is arranged or can be arranged between the form-stable container parts (6, 7).

5. 5. The small volume liquid container (1) according to claim 1, wherein the defining means (9) is removably attached to at least one of the shape-stable container parts (6, 7) and / or between both of the shape-stable container parts (6, 7), or the defining means (9) is rigidly connected to at least one of the shape-stable container parts (6, 7).

6. 6. The container (1) according to claim 1, wherein the shape-stable container parts (6, 7) are movable in a straight line relative to one another.

7. 7. The container (1) according to claim 1, wherein the shape-stable container parts (6, 7) are pivotable relative to one another.

8. 8. The small-volume liquid container (1) according to claim 1, wherein in the end position, one of the shape-stable container parts (6) is engaged with the other shape-stable container part (7) so as not to move in the direction of the start position.

9. 9. The container (1) according to claim 1, wherein the discharge connection (8) is formed on the defining means (9) and / or on one of the form-stable container parts (6, 7).

10. 10. The container (1) according to any one of the preceding claims, characterized in that a hose (17a) or a small tube is connected to the discharge connection (8).

11. 11. The container (1) according to any one of the preceding claims, wherein the storage volume (2) is filled with a liquid medium, the amount of the liquid medium in the storage volume being up to 50 ml.

12. 12. A small-volume liquid container (1) according to claim 1, wherein one of the shape-stable container parts (6, 7) or both of the shape-stable container parts (6, 7) each have a protrusion (18) which, in the end position, protrudes into a space defined laterally by the material of the defining means (9) after a relative movement of the shape-stable container parts (6, 7) relative to one another, which causes a volume change of the storage volume (2).

13. 2. The small volume liquid container (1) according to claim 1, wherein the bioprocessing technical device is a bioreactor.

14. 3. The container (1) according to claim 2, wherein the defining means (9) together with both of the form-stable container parts (6, 7) at least substantially defines the storage volume (2).

15. 4. The container (1) according to claim 3, wherein the defining means (9) is a bellows.

16. 6. The small-volume liquid container (1) according to claim 5, wherein the defining means (9) is form-fittingly attached to at least one of the form-stable container parts (6, 7) and / or between both of the form-stable container parts (6, 7), or the defining means (9) is material-fittingly connected to at least one of the form-stable container parts (6, 7).

17. 7. The container (1) according to claim 6, wherein the form-stable container parts (6, 7) form a cylinder-piston arrangement (13).

18. 8. The container (1) according to claim 7, wherein at least one of the form-stable container parts (6, 7) is formed in a plate-like or shell-like manner.

19. 10. The small volume liquid container (1) according to claim 9, wherein the defining means (9) and / or the form-stable container parts (6, 7) are provided with a filling connection (16) for filling the storage volume (2) with the liquid medium.

20. 20. The container (1) according to claim 19, wherein a hose (17b) or a small tube is connected to the filling connection (16).

21. 21. The liquid dispenser (1) according to claim 10 or 20, wherein the end of the hose (17a, 17b) or small tube facing away from the liquid dispenser (1) is sealed.

22. A packaging assembly (3) comprising a packaging (4) and a small volume liquid container (1) according to any one of claims 1 to 21 packaged in a sterile manner within said packaging.

23. 23. Use of a sterile packaged small volume liquid container (1) according to any one of claims 1 to 21 or a packaging assembly (3) according to claim 22 for adding a liquid medium into a bioprocessing technical device.

24. 24. Use according to claim 23, wherein at least the defining means (9) is at least partially made of plastic material.

25. 25. Use according to claim 24, wherein at least one of the form-stable container parts (6, 7) and / or the hose (17a, 17b) or the small tube is at least partially made of plastic material.

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