A homogenizing inner-outer combination barrel for sterile preparation, mixing and concentration

Abstract

This utility model relates to the field of homogenization technology, specifically a homogenizing inner and outer combination tank for aseptic preparation, mixing, and concentration. It includes an outer tank with a fastening kit on its outer side, and an inner tank inside the outer tank. The upper end of the inner tank has several feeding and sampling ports, each with a blind flange or pagoda connector. An air vent is located on one side of each feeding and sampling port, connected to a sterile filter. The sterile filter is fixed to the upper end of the inner tank via a flange plate. Several stirring paddles are located inside the inner tank. Compared with existing technologies, this design fulfills multiple functions including aseptic preparation, homogenization, low-temperature concentration, and degassing. When used with a high-speed vacuum homogenizer, it is particularly suitable for heat-sensitive and high-viscosity materials, offering high preparation efficiency, good mixing uniformity, stable and controllable low-temperature concentration, and significant degassing effect. It reduces costs, significantly improves production efficiency and product yield, reduces aseptic control steps in the process, and lowers the risk of contamination.

Description

Technical Field

[0001] This utility model relates to the field of homogenization technology, specifically to a homogenization inner and outer combination tank for aseptic preparation, mixing and concentration. Background Technology

[0002] In the preparation of pharmaceutical and medical device products, some materials dissolve or swell slowly (such as hyaluronic acid, collagen, and high molecular weight polymers), resulting in viscous and heterogeneous solutions that are difficult to meet the requirements of conventional mixing equipment. Furthermore, due to formulation requirements, homogenization, low-temperature concentration, and degassing must be performed simultaneously under aseptic conditions. Existing technologies and equipment, such as vacuum / reduced pressure evaporation technology and equipment, membrane separation technology and devices, freeze concentration technology, and freeze dryers, are insufficient to simultaneously meet these requirements.

[0003] Therefore, for the preparation of heat-sensitive and viscous materials, a homogenizing inner and outer combination tank that can simultaneously meet multiple functions such as aseptic preparation, homogenization, low-temperature concentration, and degassing is needed. Summary of the Invention

[0004] To overcome the shortcomings of the prior art, this utility model provides a homogenizing inner and outer combination tank for aseptic preparation, mixing and concentration.

[0005] To achieve the above objectives, a homogenizing inner and outer combined tank for aseptic preparation, mixing, and concentration is designed, comprising an outer tank with a fastening kit on its outer side, an inner tank inside the outer tank, several feeding and sampling ports at the upper end of the inner tank, a blind flange or pagoda connector at the upper end of each feeding and sampling port, an air vent on one side of each feeding and sampling port, the air vent being connected to a sterile filter, the upper end of the sterile filter being fixed to the upper end of the inner tank by a flange plate, and several stirring paddles inside the inner tank.

[0006] The outer casing has several external locking slots, which can be raised or recessed. In actual use, the external locking slots cooperate with external accessories for fixation, preventing rotation and friction during operation.

[0007] The outer barrel has several inner slots on its inner side, and the inner barrel has several locking plates on its outer side that cooperate with the inner slots.

[0008] The outer barrel has an opening at its upper end, and an elastic cap is provided at the opening.

[0009] A sealing ring is provided at the connection between the air outlet and the sterile filter.

[0010] The connection between the stirring paddle and the inner tank is provided with an arc surface.

[0011] The other end of the stirring paddle branches into several forked blades. The width of the stirring paddle is greater than the width of the forked blades, which facilitates the mixing and refining of materials.

[0012] The outer barrel includes an outer barrel lid and an outer barrel body. The outer barrel lid and the outer barrel body are connected by a threaded structure, and a sealing gasket is provided between the outer barrel lid and the outer barrel body.

[0013] The inner bucket includes an inner bucket lid and an inner bucket body. The inner bucket lid and the inner bucket body are connected by several fasteners, and a sealing gasket is provided between the inner bucket lid and the inner bucket body.

[0014] The flange plate is provided with through holes for sterile filters to pass through.

[0015] Compared with existing technologies, this invention fulfills multiple functions including aseptic preparation, homogenization, low-temperature concentration, and degassing. When used with a high-speed vacuum homogenizer, it is particularly suitable for heat-sensitive and high-viscosity materials, offering high preparation efficiency, excellent mixing uniformity, stable and controllable low-temperature concentration, and significant degassing effect. It reduces costs, significantly improves production efficiency and product yield, reduces the number of aseptic control steps in the process, and lowers the risk of contamination. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the structure of this utility model.

[0017] Figure 2 This is a schematic diagram of the structure of the outer barrel of this utility model.

[0018] Figure 3 This is a front view of the outer barrel of this utility model.

[0019] Figure 4 This is a top view of the outer barrel of this utility model.

[0020] Figure 5 This is a schematic diagram of the inner barrel structure of this utility model.

[0021] Figure 6 This is a front view of the inner barrel of this utility model.

[0022] Figure 7 This is a side view of the inner barrel of this utility model.

[0023] Figure 8 for Figure 7 Cross-sectional view along the AA direction.

[0024] Figure 9 This is a top view of the inner barrel of this utility model. Detailed Implementation

[0025] The present invention will be further described below with reference to the accompanying drawings.

[0026] like Figures 1 to 9As shown, the outer barrel 1 is provided with a fastening kit 3 on the outside, and the inner barrel 2 is provided inside the outer barrel 1. The fastening kit 3 fastens the outer barrel 1 and the inner barrel 2. The upper end of the inner barrel 2 is provided with several feeding and sampling ports 4. The upper end of the feeding and sampling ports 4 is provided with a blind plate 5 or a pagoda connector. The side of the feeding and sampling ports 4 is provided with an air outlet 6. The air outlet 6 is connected to a sterile filter 7. The upper end of the sterile filter 7 is fixed to the upper end of the inner barrel 2 by a flange plate 8. The inner barrel 2 is provided with several stirring paddles 9.

[0027] The outer casing 1 has several external locking slots 10 on its outer side, which are either raised or recessed. In actual use, the external locking slots 10 cooperate with external accessories to fix them in place and prevent rotational friction during operation.

[0028] The inner side of the outer bucket 1 is provided with several inner latches, and the outer side of the inner bucket 2 is provided with several locking plates 11 that cooperate with the inner latches. The cooperation between the inner latches and the locking plates 11 of the bucket lid fixes the inner bucket 2 and prevents rotation and friction during operation.

[0029] The outer barrel 1 has an opening at the top, and an elastic cap 12 is provided at the opening.

[0030] A sealing ring 16 is provided at the connection between the air outlet 6 and the sterile filter 7 to ensure sterility.

[0031] The connection between the stirring paddle 9 and the inner tank 2 has an arc-shaped surface. The other end of the stirring paddle 9 is forked, forming several forked blades 13. The width of the stirring paddle 9 is greater than the width of the forked blades 13, which facilitates the mixing and refining of materials.

[0032] The outer barrel 1 includes an outer barrel lid 1-1 and an outer barrel body 1-2. The outer barrel lid 1-1 and the outer barrel body 1-2 are connected by a threaded structure, and a sealing gasket 14 is provided between the outer barrel lid 1-1 and the outer barrel body 1-2. In actual use, the outer barrel 1 is made of a material that is resistant to high temperature, sterilization, and chemical corrosion, and has high rigidity, including but not limited to polypropylene, polyethylene, and polytetrafluoroethylene.

[0033] The inner barrel 2 includes an inner barrel lid 2-1 and an inner barrel body 2-2. The inner barrel lid 2-1 and the inner barrel body 2-2 are connected by several fasteners 2-3, and a sealing gasket 14 is provided between the inner barrel lid 2-1 and the inner barrel body 2-2. The inner barrel 2 is made of 316L stainless steel and has an acid and alkali resistant plating inside.

[0034] The flange plate 8 is provided with a through hole 15 for the sterile filter 7 to pass through.

[0035] When this invention is in use, the feeding and sampling port 4 is connected to the pagoda head to transfer materials when feeding or sampling is required. During the homogenization process, the feeding and sampling port 4 is connected to the blind plate 5, and a blind plate with a sealing ring is selected for sealing.

[0036] Vent 6 is used for sample degassing, concentration evaporation, and cooling. Through homogenization and vacuuming, simultaneous homogenization and evaporation concentration are achieved, solving the problem of unevenness in conventional evaporation concentration. It also removes air bubbles from the material and lowers or maintains the material's temperature. The concentrated sample can be directly pre-filled, avoiding the need for a dedicated vacuum degassing device before filling in conventional processes. Furthermore, an external 0.22µm sterile filter 7 ensures the sterility of the material.

[0037] The stirring paddle 9 ensures that the material and solvent are in equal contact during high-speed operation, while also refining the material and increasing the contact area between the material and the solvent. This guarantees high efficiency in preparation, dissolution, or swelling, as well as the homogeneity of the mixing of materials in the upper and lower parts of the mixture.

[0038] This utility model's combined container is used in the preparation of pharmaceutical and medical device products for aseptic formulation, homogenization, low-temperature concentration, and degassing. It is multifunctional, avoiding the investment in multiple functional devices and significantly reducing costs. It avoids material transfer losses and waste caused by multiple equipment pipelines, greatly improving production efficiency and product yield, reducing the number of aseptic control steps in the process, and lowering the risk of contamination.

Claims

1. A homogenized inner-outer combination barrel for aseptic formulation, mixing and concentration, comprising an outer barrel, characterized in that: The outer barrel (1) is provided with a fastening kit (3) on the outside. The inner barrel (2) is provided inside the outer barrel (1). The upper end of the inner barrel (2) is provided with several feeding and sampling ports (4). The upper end of the feeding and sampling ports (4) is provided with a blind plate (5) or a pagoda connector. The side of the feeding and sampling ports (4) is provided with an air outlet (6). The air outlet (6) is connected to a sterile filter (7). The upper end of the sterile filter (7) is fixed to the upper end of the inner barrel (2) by a flange pressure plate (8). The inner barrel (2) is provided with several stirring paddles (9).

2. The homogenizing inner and outer combination tank for aseptic preparation, mixing and concentration according to claim 1, characterized in that: The outer barrel (1) is provided with several external slots (10) on the outside. The external slots (10) are either raised or recessed. In actual use, the external slots (10) are fixed in conjunction with external accessories to prevent rotation and friction during operation.

3. A combined inner and outer homogenizer barrel for aseptic formulation, mixing and concentration according to claim 1 or 2, characterized in that: The outer barrel (1) has several inner slots on its inner side, and the inner barrel (2) has several card plates (11) on its outer side that cooperate with the inner slots.

4. A combined inner and outer homogenizer barrel for aseptic formulation, mixing and concentration according to claim 1, characterized in that: The outer barrel (1) has an opening at the top, and a tight-fitting cap (12) is provided at the opening.

5. A combined inner and outer homogenizer barrel for aseptic formulation, mixing and concentration according to claim 1, characterized in that: A sealing ring (16) is provided at the connection between the air outlet (6) and the sterile filter (7).

6. A combined inner and outer homogenizer barrel for aseptic formulation, mixing and concentration according to claim 1, characterized in that: The connection between the stirring paddle (9) and the inner tank (2) is provided with an arc surface (17).

7. A combined inner and outer homogenizer barrel for aseptic formulation, mixing and concentration according to claim 1 or 6, characterized in that: The stirring paddle (9) is forked at the other end to form several forked blades (13). The width of the stirring paddle (9) is greater than the width of the forked blades (13), which facilitates the mixing and refining of materials.

8. A combined inner and outer homogenizer barrel for aseptic formulation, mixing and concentration according to claim 1, characterized in that: The outer barrel (1) includes an outer barrel cover (1-1) and an outer barrel body (1-2). The outer barrel cover (1-1) and the outer barrel body (1-2) are connected by a threaded structure, and a sealing gasket (14) is provided between the outer barrel cover (1-1) and the outer barrel body (1-2).

9. A combined inner and outer homogenizer barrel for aseptic formulation, mixing and concentration according to claim 1, characterized in that: The inner barrel (2) includes an inner barrel lid (2-1) and an inner barrel body (2-2). The inner barrel lid (2-1) and the inner barrel body (2-2) are connected by several buckles (2-3), and a sealing gasket (14) is provided between the inner barrel lid (2-1) and the inner barrel body (2-2).

10. The combined inner and outer homogenizer barrel for aseptic formulation, mixing and concentration of claim 1, wherein: The flange plate (8) is provided with a through hole (15) for the aseptic filter (7) to pass through.

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