Modular support vessels for single-use bioprocessing containers

Abstract

The present invention provides a modular support container for a disposable bioprocess container, comprising a support container base, a support container pedestal, and a plurality of container boxes that are fixedly connected in sequence from bottom to top; the support container pedestal is provided with a liquid discharge plane, and the liquid discharge plane is provided with a liquid discharge port; the container box is surrounded by a plurality of container vertical plates, and the container vertical plates are hollow structures, provided with a liquid inlet and a liquid outlet, and connected to a cooling water circulation pipeline in a series or parallel manner. The modular support container for the disposable bioprocess container greatly reduces the processing cost and improves the flexibility of use in pharmaceutical factories.

Description

Technical Field

[0001] The present invention relates to a supporting container required for a disposable bioprocess container (Single Use Bioprocess Containers, disposable liquid storage bags, mixing bags, liquid preparation bags, bioreactors, etc.) when a single-use technology is adopted in drug production, and in particular to a modular supporting container for a disposable bioprocess container. Background Art

[0002] Single Use Systems (SUS) are a process equipment solution, usually assembled from plastic material components, used for single or phased pharmaceutical production activities. Single-use systems have been widely used in pharmaceutical processes such as cell culture / fermentation, preparation and storage of culture media and buffers, storage and transfer of process materials, final product preparation, freezing and thawing of stock solutions and semi-finished products, filling, sampling, etc. Single-use systems are used to replace stainless steel equipment, greatly reducing the initial investment cost of the project and shortening the construction period of the production line; in terms of operation, single-use systems can reduce cleaning investment, shorten production cycles, increase flexibility, and maximize the European and American drug regulatory authorities' increasing requirements for pharmaceutical companies to reduce pollution and cross-contamination risks. Single-use systems are now widely used in pharmaceutical fields such as monoclonal antibodies, vaccines, and blood products. At the same time, some chemical drug manufacturers have also adopted single-use systems.

[0003] However, because disposable bioprocess containers are made of soft plastic, they must be used with stainless steel or hard plastic support containers. A variety of support container types have been produced, such as stainless steel or plastic fixed support containers (CN208412799U). The size of such containers is fixed and cannot be disassembled when leaving the factory, and the transportation cost after leaving the factory is high; in addition, when the container reaches 2000L or 3000L, the height of these containers often exceeds the height of the door opening of the pharmaceutical factory workshop, and must be entered through a specific equipment port, and even must be placed inside the workshop before the workshop is capped during the construction phase, which greatly limits the flexibility brought by the use of the disposable system. There are also some foldable stainless steel or plastic containers (such as CN203047858U, WO2020030045A1), although the volume is reduced to a certain extent, it can only be adapted to a single disposable bioprocess container of a specific size; and its surface is designed with many matching structures for splicing, resulting in many seams and unevenness, which makes it difficult to clean; in addition, plastic foldable containers are difficult to make and costly. Summary of the invention

[0004] The present invention provides a modular support container for a disposable bioprocess container, which is used to improve the flexibility of the support container supporting the disposable bioprocess container. The technical solution is as follows:

[0005] A modular support container for a disposable bioprocess container comprises a support container base, a support container pedestal, and a plurality of container boxes which are fixedly connected in sequence from bottom to top; the support container pedestal is provided with a drainage plane, and the drainage plane is provided with a drainage port; the container box is surrounded by a plurality of container vertical plates, and the container vertical plates are hollow structures, provided with a liquid inlet and a liquid outlet, and are connected to a cooling water circulation pipeline in a series or parallel manner.

[0006] The supporting container base includes a base body, and the four corners of the bottom of the base body are provided with internal threads for screwing into universal wheels or fixing feet; the bottom of the base body has two groups of mutually perpendicular grooves; the top of the base body is provided with a positioning pin that cooperates with the supporting container base.

[0007] The support container base also includes a column at the lower part of the liquid discharge plane, and the column cooperates with the positioning pin of the support container base.

[0008] The drainage plane is surrounded by square tubes, a drainage port is arranged on the drainage plane, and three slopes, namely, a first slope, a second slope and a third slope, are connected between the square tubes. The three slopes form the lowest position at the drainage port.

[0009] The bottom plane of the container where the liquid discharge port is located is provided with a liquid discharge port support plate, the liquid discharge port support plate is fixed to the bottom plane of the container through positioning pins and positioning holes, and one or more liquid discharge holes are processed in the middle of the liquid discharge port support plate.

[0010] The top of the container stand is provided with a positioning hole, and the bottom is provided with a stand positioning pin.

[0011] A double-leaf door is arranged in the middle of the container stand.

[0012] The container stand is provided with a sampling port opening, and the inner side of the sampling port opening is provided with two symmetrical slots fixed to the container stand, and a sampling port support plate is matched between the two symmetrical slots.

[0013] In the single container box, the liquid outlet of the container vertical plate is connected to the liquid inlet of the adjacent container vertical plate through a hose, so that the cooling water between the container vertical plates in the single container box forms an internal circulation, and the inlet pipe and return pipe of the external cooling water are respectively connected to the remaining two interfaces on the container box.

[0014] Several container boxes are connected to the cooling water circulation pipeline in parallel or in series.

[0015] The modular support container of the disposable bioprocess container greatly reduces processing costs and improves the flexibility of use in pharmaceutical factories. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 is a schematic structural diagram of a first embodiment of a modular support container of the disposable bioprocess container;

[0017] Figure 2 is a structural schematic diagram of a second embodiment of a modular support container of the disposable bioprocess container;

[0018] Figure 3 is a structural schematic diagram of the first embodiment of the supporting container base;

[0019] Figure 4 is a structural schematic diagram of the second embodiment of the supporting container base;

[0020] Figure 5 is a schematic structural diagram of the support container base;

[0021] Figure 6 is a schematic diagram of the structure of the column in the support container base;

[0022] Figure 7 is a schematic diagram of the drain port at the bottom of the support container base;

[0023] Figure 8 is a partial cutaway view of the drain port;

[0024] Fig. 9 is a schematic diagram of the drain port support plate;

[0025] Fig.10 is a partial dissected view of the drain port support plate after assembly;

[0026] Fig.11 is a structural schematic diagram of the first embodiment of the container stand;

[0027] Fig.12 is a structural schematic diagram of the second embodiment of the container stand;

[0028] Fig.13 is a schematic diagram of the sampling port opening;

[0029] Fig.14 is a schematic diagram of the sampling port support plate;

[0030] Fig.15 It is a partial cutaway view of the sampling port support plate after assembly;

[0031] Fig.16 It is a schematic diagram of a flat buckle;

[0032] Fig.17 It is a schematic diagram of flat buckle fastening

[0033] Fig.18 It is a schematic diagram of the corner buckle;

[0034] Fig.19 Schematic diagram of corner buckle fastening. DETAILED DESCRIPTION

[0035] like Figure 1 and Figure 2 As shown, the modular support container of the disposable bioprocess container includes a support container base 100, a support container pedestal 200, and a container box. The lower end of the support container base 200 is fixed on the support container base 100, and a plurality of container boxes can be fixed above the support container base 200. The container box is surrounded by a container vertical plate 300. The container vertical plate 300 is a hollow structure and is connected to a cooling water circulation pipeline.

[0036] like Figure 3 As shown, the support container base 100 includes a base body 1, which can be made of stainless steel or plastic (polyethylene, polypropylene, nylon, ABS, etc.), and is square. The four corners of the bottom of the base body 1 are provided with internal threads for screwing into the universal wheel 3 or Figure 4 The fixed feet 6 shown can be customized according to user requirements to achieve different needs such as convenient movement or load bearing.

[0037] The bottom of the base body 1 has two sets of mutually perpendicular grooves, namely a longitudinal groove 2 and a transverse groove 4, so that the front fork of the forklift can enter from two different directions for easy transportation.

[0038] The top of the base body 1 is provided with a plurality of positioning pins 5 for docking with other module components. The positioning pins 5 are provided with four cylindrical ones and are distributed at the four corners of the top of the base body 1 .

[0039] The support container base 200 can be made of stainless steel plates and stainless steel square tubes spliced ​​and welded together, or it can be made of plastic raw materials through injection molding.

[0040] like Figure 5 As shown, the support container base 200 includes an upper drainage plane and a lower column, and the drainage plane is a square, and its shape corresponds to the support container base 100. The drainage plane is surrounded by square tubes, and between the square tubes are three connected inclined planes with slopes, namely, a first inclined plane 7, a second inclined plane 8, and a third inclined plane 9. The first inclined plane 7 and the third inclined plane 9 are located on both sides of the second inclined plane 8, and the first inclined plane 7 and the third inclined plane 9 are symmetrically arranged.

[0041] There are multiple cylindrical positioning holes 11 evenly distributed on the square tubes to achieve connection with the upper parts. Figure 6 As shown, there are four square tube-shaped columns 10 around the bottom, and a groove 12 is provided in the center of the lower surface of the column, which can be connected with Figure 3 or Figure 4 The supporting container base 100 is connected.

[0042] Combination Figure 7 and Figure 8 As shown, the discharge port of the discharge plane is shaped as a multi-step step, the bottom of which is the container bottom plane 13, and the container bottom plane 13 is surrounded by a square hole 14 as the discharge port, and the square hole 14 is located in the middle of one side of the discharge plane.

[0043] The drainage plane extends from the periphery to the square hole 14, forming a height difference from the periphery to the center near the front, so as to achieve complete drainage of the disposable bioprocess container.

[0044] A liquid discharge port support plate 15 is disposed at the square hole 14 . The liquid discharge port support plate 15 is placed on the container bottom plane 13 . Positioning holes are disposed at four corners of the container bottom plane 13 .

[0045] like Fig. 9 and Fig.10 As shown, the drainage port support plate 15 can be processed with one or more drainage holes in the middle as needed, and the drainage hose on the disposable bioprocess container storage bag can pass through these holes to the outside of the container.

[0046] The four corners of the bottom of the drain port support plate 15 are provided with positioning pins 16 which match with the positioning holes of the bottom plane 13 of the container.

[0047] After the drain port support plate 15 is aligned with the positioning holes of the container bottom plane 13 and installed, the upper surface of the drain port support plate 15 is flush with the container bottom plane 13 , forming a bottom plane supporting the container base 100 .

[0048] like Fig.11 and Fig.12 As shown, the container stand 300 is made of stainless steel or plastic material by injection molding, and its interior is a hollow structure, and cooling water can be passed through to cool the disposable bioprocess container.

[0049] There is a positioning hole 23 on the top of the container stand 300 to facilitate positioning of other container stand stacked thereon.

[0050] Two pipe openings are provided on the outer side of the container upright plate 300, which are the cooling water inlet 18 and the drain port 22, so as to realize the circulation of cooling water; the inlet 18 and the drain port 22 are arranged at the diagonal corners of the container upright plate 300, and the inlet and outlet can be interchanged according to actual use. At this time, the inlet 18 serves as the drain port, and the drain port 22 serves as the inlet.

[0051] A stand plate positioning pin 21 is provided at the bottom of the container stand plate 300, which can be used for positioning when it is installed on a container base or stacked on other stand plates.

[0052] A double door 19 can be provided in the middle position of the container stand 300, which can be configured when the modular support container provided by the present invention is larger. The double door 19 can be opened when installing the modular support container for disposable bioprocess, which is convenient for installation. The double door is generally configured at the container stand directly in front of the container body.

[0053] The lower end of the container stand 300 may be provided with a sampling port opening 20, which can be configured when the modular support container for a disposable bioprocess has a sampling requirement.

[0054] When the supporting container does not need to be equipped with a double door or installed on the other three facades, you can choose Fig.12 The interior of the container is also hollow, which can realize the circulation of cooling water. The sampling port opening 20 can also be selected.

[0055] like Fig.13 As shown, there are two symmetrical slots 24 on the inner side of the container stand 300. The slots 24 are right-angle bent structures, and the bent parts are arranged opposite to each other. Fig.14 The supporting plate 25 is made of stainless steel or plastic, and is rectangular in shape. A sampling port opening is provided in the middle. One or more sampling port openings 20 can be provided according to the needs, so that the sampling tubes on the disposable bioprocess container can pass through these holes. Fig.15 As shown, when in use, the sampling port support plate 25 enters from the card slot 24 and falls to the bottom of the container stand by gravity.

[0056] When in use, the movable support container base 100 is placed at a designated position in the factory, and then the support container base 100 is fixed. The support container base 200 is docked on top of it, and the two are fastened by hinges or buckles. In this embodiment, the vertical plate and the base are connected using the following method: Fig.16 The stainless steel buckle (flat buckle) that can be connected 180 degrees is used for fastening. The connection diagram is as follows Fig.17Four container uprights 300 are installed above the container support base 200, and the container uprights and the container support base are fixed by hinges or buckles, and the adjacent container uprights are fixed. In this embodiment, the uprights are connected by using Fig.18 The stainless steel buckle (corner buckle) that can be connected at 90 degrees is used for fastening. The connection diagram is as follows Fig.19 The flat buckle and the corner buckle are common existing products, and the present invention will not elaborate on them.

[0057] A hose 27 is used to connect the cooling water pipe interface between the container vertical plates, so that the cooling water between the container vertical plates on the four sides forms an internal circulation, and the external cooling water inlet and return pipes are respectively connected to the remaining two interfaces on the container vertical plates.

[0058] When a larger support container is needed, only Figure 2 Stack the container vertical plates upwards, fasten the upper and lower container vertical plates with hinges or buckles, connect the cooling water circulation pipelines of the upper and lower container boxes, and connect the external cooling water inlet pipe and return pipe to the remaining two interfaces on all container vertical plates. When the third layer or more is needed, follow the above operation in the same way.

[0059] The present invention has the following beneficial effects:

[0060] 1. Compress the volume of the support container to the maximum extent, facilitate transportation after leaving the factory, and reduce the cost of use for end users;

[0061] 2. The support container is designed as a component and can be assembled when used. It is less restricted by space and does not need to be installed during the workshop construction stage;

[0062] 3. The support container is modularly designed. Modules with different configurations can be used as standard parts to reduce production costs. Users can choose according to their needs;

[0063] 4. The support container can be disassembled again after use, which is convenient for storage or transfer to other workshops, maximizing flexibility;

[0064] 5. After modular design, users do not need to purchase a single container, but only need to purchase a certain number of modules to freely combine containers for different purposes. Volumes above 1000L can be directly stacked.

Claims

1. A modular support container for a disposable bioprocess container, characterized in that: It includes a supporting container base, a supporting container pedestal, and several container boxes which are fixedly connected in sequence from bottom to top; the supporting container pedestal is provided with a drainage plane, and the drainage plane is provided with a drainage port; the container box is surrounded by several container uprights, and the container uprights are hollow structures, provided with a liquid inlet and a liquid outlet, and are connected to a cooling water circulation pipeline in series or in parallel; the drainage plane is surrounded by square tubes, and a drainage port is provided on the drainage plane, and three inclined planes, namely a first inclined plane, a second inclined plane, and a third inclined plane, are connected between the square tubes, and the three inclined planes form the lowest position at the drainage port; in a single container box, the liquid outlet of the container upright is connected to the liquid inlet of the adjacent container upright through a hose, so that the cooling water between the container uprights in the single container box forms an internal circulation, and the inlet pipe and return pipe of the external cooling water are respectively connected to the remaining two interfaces on the container box.

2. The modular support container for a disposable bioprocess container according to claim 1, characterized in that: The supporting container base includes a base body, and the four corners of the bottom of the base body are provided with internal threads for screwing into universal wheels or fixing feet; the bottom of the base body has two groups of mutually perpendicular grooves; the top of the base body is provided with a positioning pin that cooperates with the supporting container base.

3. The modular support container for a disposable bioprocess container according to claim 1, characterized in that: The support container base also includes a column at the lower part of the liquid discharge plane, and the column cooperates with the positioning pin of the support container base.

4. The modular support container for a disposable bioprocess container according to claim 1, characterized in that: The bottom plane of the container where the liquid discharge port is located is provided with a liquid discharge port support plate, the liquid discharge port support plate is fixed to the bottom plane of the container through positioning pins and positioning holes, and one or more liquid discharge holes are processed in the middle of the liquid discharge port support plate.

5. The modular support container for a disposable bioprocess container according to claim 1, characterized in that: The top of the container stand is provided with a positioning hole, and the bottom is provided with a stand positioning pin.

6. The modular support container for a disposable bioprocess container according to claim 1, characterized in that: A double-leaf door is arranged in the middle of the container stand.

7. The modular support container for a disposable bioprocess container according to claim 1, characterized in that: The container stand is provided with a sampling port opening, and the inner side of the sampling port opening is provided with two symmetrical slots fixed to the container stand, and a sampling port support plate is matched between the two symmetrical slots.

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