A bacterial endotoxin removal device
By filling the column with activated carbon particles coated with cellulose acetate membrane and using a shaking mechanism, the problems of unsafe bacterial endotoxin removal and carbon ash shedding in the prior art are solved, and safe and efficient bacterial endotoxin removal is achieved.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- JIANGSU CHARUI BIOTECHNOLOGY CO LTD
- Filing Date
- 2023-11-03
- Publication Date
- 2026-06-26
AI Technical Summary
Existing technologies cannot effectively and safely remove bacterial endotoxins from injectable and medical device products, and activated charcoal is prone to shedding during use, which may damage blood components.
The column is filled with activated carbon particles coated with cellulose acetate membrane, and a shaking mechanism is used to remove the solution at room temperature, avoiding the use of strong acids or alkalis and ensuring safety and removal efficiency.
It effectively removes bacterial endotoxins at room temperature, avoids charcoal shedding, ensures solution safety, improves removal efficiency, and simplifies the operation process.
Smart Images
Figure CN224404444U_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of biomedical technology, and in particular to a bacterial endotoxin removal device. Background Technology
[0002] Bacterial endotoxins are unique structures on the cell walls of Gram-negative bacteria, primarily composed of lipopolysaccharides (LPS) with strong pyrogenic activity. While endotoxins do not cause harm when ingested via the digestive tract, they can lead to varying degrees of endotoxemia when injected into the bloodstream. Therefore, bacterial endotoxin levels in raw materials and excipients used in the production of injectable drugs and Class III medical devices must be controlled to ensure product quality and medication safety. Existing methods for inactivating bacterial endotoxins include strong acids, strong alkalis, and dry burning at temperatures above 250°C for 1 hour. Only one of these conditions can inactivate endotoxins. However, in practice, many products cannot meet these conditions, making the control of the initial amount of bacterial endotoxins crucial.
[0003] Activated carbon, due to its porous nature, can adsorb fine substances from various liquids during filtration. It is commonly used in water treatment for decolorization, deodorization, dechlorination, removal of organic matter and heavy metals, removal of synthetic detergents, bacteria, viruses, and radioactive pollutants, and is also frequently used in tertiary wastewater treatment. While activated carbon has a certain removal effect on organic matter, its adsorption capacity decreases after a period of use, causing previously adsorbed substances to be released back into the water. Activated carbon has a large hydrophobic pore structure, effectively removing bilirubin, creatinine, uric acid, glycosides, phenols, guanidines, and organic acids. However, due to its irregular hydrophobic surface and poor mechanical properties, activated carbon is prone to shedding ash, and its hydrophobic surface may damage proteins and cells in the blood. Therefore, activated carbon cannot be directly used to remove bacterial endotoxins. Thus, designing a versatile removal device that can broadly remove bacterial endotoxins from various products and is easy to operate is crucial. Utility Model Content
[0004] In order to remove bacterial endotoxins from various product solutions without using irritating solvents or damaging the components of the product solutions, this application provides a bacterial endotoxin removal device. This removal device is simple to operate, widely applicable, and highly practical.
[0005] The bacterial endotoxin removal device provided in this application adopts the following technical solution:
[0006] A bacterial endotoxin removal device includes a column and a shaking mechanism. The column has an internal cavity filled with several activated carbon particles coated with cellulose acetate membranes. Openings are located at both the top and bottom of the column, and several 0.22-micron microporous filter membranes are spaced apart at both ends. The shaking mechanism clamps and fixes the column, shaking it to ensure sufficient contact between the solution entering the column and the activated carbon particles.
[0007] By employing the above technical solution, the column is filled with activated carbon particles coated with a cellulose acetate membrane. These activated carbon particles effectively remove the solution entering the column, thereby eliminating bacterial endotoxins. The endotoxin removal process takes place at room temperature and does not utilize strong acids, alkalis, or other irritating corrosive reagents. The cellulose acetate membrane coating prevents activated carbon ash from detaching and entering the solution during endotoxin removal, thus avoiding damage to proteins and cells from activated carbon fragments entering the bloodstream. A shaking mechanism agitates the column, ensuring sufficient contact between the solution and the activated carbon particles, guaranteeing thorough removal of bacterial endotoxins and improving the efficiency of endotoxin removal.
[0008] Optionally, the rocking mechanism includes a motor, a cam, a movable clamping rod, and a fixed frame. The output shaft of the motor is parallel to and spaced apart from the column. The output shaft of the motor is fixedly connected to the center of the cam. A cam groove is formed on the surface of the cam. One end of the movable clamping rod is located in the cam groove, and the other end of the movable clamping rod is fixedly connected to the outer side of the column. The fixed frame fixes the movable clamping rod. The motor drives the cam to rotate, and the cam groove drives the movable clamping rod to move along a direction perpendicular to the column. The movable clamping rod drives the column to move synchronously, thereby rocking the inside of the column.
[0009] By adopting the above technical solution, the motor can drive the cam to rotate, and the cam groove opened on the cam can drive the moving clamping rod to move. During the displacement, the moving clamping rod can drive the column to move synchronously, so that the column moves back and forth, thereby allowing the activated carbon particles inside the column to fully shake and contact the solution, improving the removal efficiency of activated carbon particles on bacterial endotoxins in the solution.
[0010] Optionally, a positioning post is fixedly connected to the bottom of one end of the movable clamping rod, the positioning post being located in the cam groove, and the other end of the movable clamping rod is C-shaped, with the C-shaped end of the movable clamping rod sleeved on the outside of the post, and the open end of the C-shaped movable clamping rod being fixed and locked by bolts and nuts.
[0011] By adopting the above technical solution, the positioning column can always be in contact with the cam groove of the cam, so that the moving clamping rod can always move with the rotation of the cam, thereby driving the column to move and achieving the effect of shaking the activated carbon particles and solution inside the column. One end of the moving clamping rod is C-shaped, which, together with bolts and nuts, can effectively fix and clamp the column, so that the column always remains vertical during the movement, improving the stability of the column.
[0012] Optionally, the fixing frame is located between the cam and the column. The fixing frame includes two parallel and spaced fixing plates, which are respectively located on the front and rear sides of the movable clamping rod. The fixing plates are provided with slots on the opposite side of each other. The front and rear sides of the movable clamping rod are respectively located in the two slots, and the slots guide and support the movable clamping rod.
[0013] By adopting the above technical solution, the movable clamping rod is located in the slots between the two fixed plates. The slots provide guidance and support for the movable clamping rod, so that the movable clamping rod always remains horizontal during the movement, thereby improving the stability of the movable clamping rod in moving the column.
[0014] Optionally, two 0.22-micron microporous filter membranes are fixedly connected to the inner sidewalls at the upper and lower ends of the column, and the two 0.22-micron microporous filter membranes are arranged at an interval between each other.
[0015] By adopting the above technical solution, two 0.22-micron microporous filter membranes are respectively arranged on the inner walls of the upper and lower ends of the column. This eliminates the need to distinguish between the upper and lower ends during use, allowing for direct and convenient application and improving work efficiency. The two 0.22-micron microporous filter membranes are spaced apart to enhance the filtration efficiency of the solution, thereby removing impurities from the solution.
[0016] Optionally, the 0.22-micron microporous filter membrane is a 0.22-micron polyethersulfone microporous filter membrane.
[0017] By adopting the above technical solution, the 0.22-micron polyethersulfone microporous filter membrane can further remove impurities in the solution and can also concentrate the solution to increase its concentration.
[0018] Optionally, plungers are provided at the openings at the upper and lower ends of the column.
[0019] By adopting the above technical solution, the plunger enables the column cleaning process to be started and stopped at will, making the operation simple, convenient and quick.
[0020] In summary, this application has the following beneficial effects:
[0021] 1. The column in this application is for single use, which keeps the activated carbon particles in the column in a highly adsorbed state. This avoids the problem that the adsorption capacity of activated carbon decreases after a period of use, causing previously adsorbed substances to be released back into the solution. The activated carbon particles are coated with a cellulose acetate membrane, which can prevent activated carbon ash from falling off and entering the solution during use, thus ensuring the safety of the product solution.
[0022] 2. Two 0.22-micron polyethersulfone microporous membranes are installed at both the top and bottom of the column, which can effectively remove impurities from the solution, improve the safety of the solution during use, and also concentrate the solution. The shaking mechanism can shake the column, thereby ensuring full contact between the activated carbon particles inside the column and the solution. This allows the activated carbon particles to fully remove bacterial endotoxins contained in the solution, and also ensures full contact between the solution and the 0.22-micron polyethersulfone microporous membrane, enabling the 0.22-micron polyethersulfone microporous membrane to fully filter the solution, improving the column's solution removal efficiency. Attached Figure Description
[0023] Figure 1 This is a schematic diagram of the entire cleaning device in the embodiment. Figure I ;
[0024] Figure 2 This is a schematic diagram of the entire cleaning device in the embodiment. Figure II ;
[0025] Figure 3 This is a schematic diagram of a partial cross-sectional structure of the column in the embodiment;
[0026] Figure 4 This is a schematic diagram of the structure of the movable clamping rod and the fixing plate in the embodiment.
[0027] Explanation of reference numerals in the attached drawings: 1. Column; 2. 0.22-micron microporous filter membrane; 3. Plunger; 4. Motor; 5. Cam; 6. Moving clamping rod; 7. Fixing plate; 8. Cam groove; 9. Positioning column; 10. Bolt; 11. Nut; 12. Slot; 13. Activated carbon granules; 14. Worktable. Detailed Implementation
[0028] The technical solutions in the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments.
[0029] Identical parts are indicated by the same reference numerals. It should be noted that the terms "upper," "lower," "left," "right," "front," "rear," "top," "bottom," "inner," and "outer" used in the following description refer to directions in the accompanying drawings, but are not limiting.
[0030] The following is in conjunction with the appendix Figure 1-4 This application will be described in further detail.
[0031] This application discloses a bacterial endotoxin removal device.
[0032] Example
[0033] Reference Figures 1-3 A bacterial endotoxin removal device includes a column 1 and a shaking mechanism. The column 1 has an internal cavity filled with several activated carbon particles 13 coated with cellulose acetate membranes. Openings are located at both the top and bottom of the column 1, with plungers 3 at each opening. Two 0.22-micron polyethersulfone microporous membranes are fixedly connected to the inner walls of both the top and bottom of the column 1 at intervals. The shaking mechanism clamps and fixes the column 1, and shakes it to ensure that the solution entering the column 1 comes into full contact with the activated carbon particles 13. The rocking mechanism includes a motor 4, a cam 5, a movable clamping rod 6, and a fixed frame. The output shaft of the motor 4 is parallel to and spaced apart from the column 1. The output shaft of the motor 4 is fixedly connected to the center of the cam 5. The surface of the cam 5 is provided with a cam groove 8. One end of the movable clamping rod 6 is fixedly connected to a positioning post 9, which is located in the cam groove 8. The other end of the movable clamping rod 6 is C-shaped. The C-shaped end of the movable clamping rod 6 is sleeved on the outside of the column 1. The C-shaped open end of the movable clamping rod 6 is fixed and locked by bolts 10 and nuts 11.
[0034] Reference Figure 4 A fixing frame secures the movable clamping rod 6. The fixing frame is located between the cam 5 and the column 1. The fixing frame includes two parallel and spaced fixing plates 7, which are located on the front and rear sides of the movable clamping rod 6, respectively. A slot 12 is provided on one side of each fixing plate 7 facing each other. The front and rear sides of the movable clamping rod 6 are respectively located in the two slots 12, which guide and support the movable clamping rod 6. The motor 4 drives the cam 5 to rotate, and the cam groove 8 drives the movable clamping rod 6 to move along a direction perpendicular to the column 1. The movable clamping rod 6 drives the column 1 to move synchronously, thereby causing the interior of the column 1 to sway.
[0035] The column 1 in this application is for single use, ensuring that the activated carbon particles 13 within it remain in a highly adsorbed state. This avoids the problem of reduced adsorption capacity after a period of use, preventing the release of previously adsorbed substances back into the solution. The activated carbon particles 13 are coated with a cellulose acetate membrane, preventing carbon ash from detaching and entering the solution during use, thus ensuring the safety of the product solution. For solutions intended to be injected into the bloodstream, the presence of activated carbon in the solution could potentially damage proteins and cells in the blood due to its hydrophobic surface, posing a health risk after entry. The interior of column 1 is filled with activated carbon particles 13 coated with a cellulose acetate membrane. These activated carbon particles 13 effectively remove the solution entering the column 1, thereby eliminating bacterial endotoxins. The endotoxin removal process is conducted at room temperature without the use of strong acids, alkalis, or other corrosive agents. The cellulose acetate membrane coating on the activated carbon particles 13 prevents carbon ash from detaching and entering the solution during endotoxin removal, thus avoiding damage to proteins and cells from activated carbon fragments entering the bloodstream. A shaking mechanism agitates column 1, ensuring sufficient contact between the solution and the activated carbon particles 13, guaranteeing thorough removal of bacterial endotoxins and improving the efficiency of endotoxin removal.
[0036] The inner walls of the top and bottom ends of column 1 are respectively provided with two 0.22-micron microporous filter membranes 2, allowing for direct use without distinguishing between the top and bottom ends, which is convenient, quick, and improves work efficiency. The two 0.22-micron microporous filter membranes 2 are spaced apart to improve the filtration efficiency of the solution, thereby removing impurities. The plunger 3 allows the purging process of column 1 to be started and stopped at will, making operation simple and convenient. The presence of two 0.22-micron polyethersulfone microporous filter membranes at both the top and bottom ends of column 1 effectively removes impurities from the solution, improves the safety of solution use, and also allows for solution concentration. The shaking mechanism can shake the column 1, thereby ensuring that the activated carbon particles 13 inside the column 1 come into full contact with the solution. This allows the activated carbon particles 13 to effectively remove bacterial endotoxins from the solution, and also allows the solution to come into full contact with the 0.22-micron polyethersulfone microporous filter membrane, enabling the 0.22-micron polyethersulfone microporous filter membrane to effectively filter the solution, thus improving the removal efficiency of the column 1.
[0037] Motor 4 drives cam 5 to rotate. The cam groove 8 of cam 5 drives the movable clamping rod 6 to move. During the displacement, the movable clamping rod 6 drives the column 1 to move synchronously, causing the column 1 to move back and forth. This allows the activated carbon particles 13 inside the column 1 to fully shake and contact with the solution, improving the removal efficiency of activated carbon particles 13 against bacterial endotoxins in the solution. The positioning column 9 is always in contact with the cam groove 8 of cam 5, ensuring that the movable clamping rod 6 moves with the rotation of cam 5, thereby driving the column 1 to move and achieve the effect of shaking the activated carbon particles 13 and solution inside the column 1. One end of the movable clamping rod 6 is C-shaped, which, together with bolt 10 and nut 11, can effectively fix and clamp the column 1, ensuring that the column 1 remains vertical during movement and improving the stability of the column 1. The movable clamping rod 6 is located in the slots 12 in the two fixed plates 7. The slots 12 provide guidance and support for the movable clamping rod 6, so that the movable clamping rod 6 always remains horizontal during the movement, thereby improving the stability of the movable clamping rod 6 in moving the column 1.
[0038] The capacity of column 1 can be adjusted according to the actual amount of solution to be removed. After the solution is removed by activated carbon particles 13 in column 1, the bacterial endotoxin level inside the solution reaches below 0.25 EU / mL, which meets national standards under mild conditions. It is convenient, quick, and highly practical. The removal device in this application can handle liquids with excessive bacterial endotoxin levels. It fills column 1 at a rate of 50 mL / min, vibrates for 10 minutes using motor 4, and then filters out the liquid inside column 1. This removal device is convenient and quick to use; motor 4 is portable, detachable, and reusable.
[0039] The manufacturer of the 0.22-micron polyethersulfone microporous filter membrane is Hangzhou Kebaite Filter Material Co., Ltd., and the model number is PES (polyethersulfone), 33mm. Here, 0.22 microns is the diameter of the micropores on the filter membrane, and 33mm is the size of the filter membrane.
[0040] Working principle:
[0041] The motor 4 is placed vertically with its output shaft pointing upwards. The cam 5 is positioned above the motor 4 and horizontally. The output shaft of the motor 4 is vertically inserted into the center hole of the cam 5 for a fixed connection. The movable clamping rod 6 is placed horizontally. Two fixing plates 7 are placed on the front and rear sides of the movable clamping rod 6, respectively. The front and rear ends of the movable clamping rod 6 are inserted into the slots 12. The fixing plates 7 raise the movable clamping rod 6 to a certain height and provide support. The slots 12 guide the movable clamping rod 6. The positioning pin 9 at one end of the movable clamping rod 6 is vertically inserted into the cam groove 8. The column 1 is vertically inserted into the C-shaped end of the movable clamping rod 6. The C-shaped opening end is fixed with bolts 10 and nuts 11, thereby fixing the column 1 to the C-shaped end of the movable clamping rod 6, ensuring that the column 1 remains vertical. Open the openings at both the top and bottom of column 1, connect pipes to the openings, and connect the solution for removing bacterial endotoxins to the pipe at the top of column 1. The solution enters the interior of column 1 through the opening at the top. Motor 4 and fixing plate 7 are installed on workbench 14 for operation. The C-shaped end of the movable clamping rod 6 has a certain degree of elasticity and can deform to clamp and fix column 1.
[0042] When motor 4 is started, its output shaft drives cam 5 to rotate synchronously. Cam 5 rotates around the output shaft of motor 4. During rotation, the non-circular design of cam groove 8 allows it to move the movable clamping rod 6 back and forth horizontally. Supported and guided by the fixing plate 7 and the slot 12, the movable clamping rod 6 will not fall off. The C-shaped end of the movable clamping rod 6 drives the column 1 to move horizontally synchronously, thus shaking the solution and activated carbon particles 13 inside the column 1. This ensures that the solution inside the column 1 comes into full contact with the 0.22-micron polyethersulfone microporous filter membrane and activated carbon particles 13. The 0.22-micron polyethersulfone microporous membrane thoroughly filters the solution and also blocks the activated carbon particles 13. This allows the solution to be completely transported out of the pipe at the bottom of the column 1 after being filtered by the 0.22-micron polyethersulfone microporous membrane and the activated carbon particles 13 remove bacterial endotoxins. During this process, the activated carbon particles 13 are trapped inside the column 1 by the 0.22-micron polyethersulfone microporous membrane.
[0043] This specific embodiment is an illustration of this application, but it is not intended to limit this application. Any changes, modifications, additions, or substitutions made within the scope of this application shall fall within the protection scope of this application. After reading this specification, those skilled in the art may make modifications to this embodiment without contributing any inventive step, but as long as they are within the scope of the claims of this application, they shall be protected by patent law.
Claims
1. A bacterial endotoxin removal device, characterized in that: It includes a column (1) and a shaking mechanism; the inside of the column (1) is provided with a cavity, and the cavity is filled with a number of activated carbon particles (13) wrapped with cellulose acetate membranes. The upper and lower ends of the column (1) are respectively provided with openings, and a number of 0.22-micron microporous filter membranes (2) are provided at intervals at both the upper and lower ends of the column (1). The shaking mechanism clamps and fixes the column (1), and the shaking mechanism is used to shake the column (1) so that the solution entering the column (1) comes into full contact with the activated carbon particles (13).
2. The bacterial endotoxin removal device according to claim 1, characterized in that: The shaking mechanism includes a motor (4), a cam (5), a movable clamping rod (6), and a fixing frame. The output shaft of the motor (4) is parallel to and spaced apart from the column (1). The output shaft of the motor (4) is fixedly connected to the center of the cam (5). A cam groove (8) is provided on the surface of the cam (5). One end of the movable clamping rod (6) is located in the cam groove (8). The other end of the movable clamping rod (6) is fixedly connected to the outside of the column (1). The fixing frame fixes the movable clamping rod (6). The motor (4) drives the cam (5) to rotate. The cam groove (8) drives the movable clamping rod (6) to move along a direction perpendicular to the column (1). The movable clamping rod (6) drives the column (1) to move synchronously, thereby shaking the inside of the column (1).
3. The bacterial endotoxin removal device according to claim 2, characterized in that: One end of the movable clamping rod (6) is fixedly connected to a positioning post (9), which is located in the cam groove (8). The other end of the movable clamping rod (6) is C-shaped. The C-shaped end of the movable clamping rod (6) is sleeved on the outside of the column (1). The C-shaped opening end of the movable clamping rod (6) is fixed and locked by bolts (10) and nuts (11).
4. The bacterial endotoxin removal device according to claim 3, characterized in that: The fixing frame is located between the cam (5) and the column (1). The fixing frame includes two parallel and spaced fixing plates (7). The two fixing plates (7) are located on the front and rear sides of the movable clamping rod (6), respectively. The fixing plates (7) are provided with slots (12) on the side facing each other. The front and rear sides of the movable clamping rod (6) are located in the two slots (12), respectively. The slots (12) guide and support the movable clamping rod (6).
5. The bacterial endotoxin removal device according to claim 4, characterized in that: The inner walls of the upper and lower ends of the column (1) are respectively fixedly connected to two 0.22 micrometer microporous filter membranes (2), and the two 0.22 micrometer microporous filter membranes (2) are arranged at intervals.
6. The bacterial endotoxin removal device according to claim 5, characterized in that: The 0.22-micron microporous filter membrane (2) is a 0.22-micron polyethersulfone microporous filter membrane.
7. The bacterial endotoxin removal device according to claim 4, characterized in that: The upper and lower ends of the column (1) are respectively provided with plungers (3).