High efficiency blood product production device and process

Abstract

The application discloses the technical field of biological medicine and blood products and relates to a high-efficiency blood product production device and process, which comprises a shell, a first electromagnet fixedly connected to the inner top wall of the shell, a second electromagnet fixedly connected to the inner bottom wall of the shell, a magnet ring in sliding fit with the inner side wall of the shell, a filter plate fixedly connected to the inner side wall of the magnet ring, the filter plate dividing the shell into an upper chamber and a lower chamber, a plurality of filter holes being formed in the filter plate, a plurality of upper pipes fixedly connected to the top wall of the filter plate, a plurality of lower pipes fixedly connected to the bottom wall of the filter plate, the upper pipes and the lower pipes being in communication with the filter holes, a feeding port being formed in the top wall of the upper chamber, a first discharging port being formed in the bottom wall of the lower chamber, a collecting assembly being in communication with the first discharging port and used for sucking the blood plasma in the shell, and a second discharging port being formed in the side wall of the upper chamber.

Description

Technical Field

[0001] This invention belongs to the field of biopharmaceutical and blood product technology, specifically a highly efficient blood product manufacturing device and process. Background Technology

[0002] Blood products refer to the collective term for plasma protein components and formed elements of blood cells produced from the plasma of healthy individuals or specifically immunized individuals through separation, purification, or recombinant DNA technology. Current technologies commonly employ gel adsorption to extract coagulation factors. After gel adsorption, the plasma needs to be filtered and collected, and washed to elute active protein components. Current gel filtration collection primarily relies on manual filtration, which has low efficiency. Because some types of gel particles are quite fragile, the solids concentration gradually increases during filtration, leading to a greater pressure differential. Excessive pressure differential can damage these fragile gel particles, increasing material loss during production. Furthermore, the broken gel fragments flowing into the plasma tank can adversely affect subsequent production processes.

[0003] To address the aforementioned issues, Chinese Patent Publication No. CN108245986B discloses a plasma adsorption filtration device for the production of coagulation factor blood products. The device includes a plasma adsorption tank: an adjustable-speed stirring device at the top, consisting of an adjustable-speed stirring motor and double-layered stirring blades; a plasma inlet and a gel addition hole at the top; a temperature-controlled jacket within the tank body, with the temperature controlled by temperature-controlled circulating water; and a plasma outlet at the bottom. The plasma delivery system comprises a feed pipe and a feed pump, connected to… The plasma adsorption tank has a plasma outlet at the bottom and a feed inlet at the top of the gel filter. The gel filter is equipped with an adjustable-speed stirring scraper at the top, consisting of an adjustable-speed stirring motor and a vertical scraper. An inner filter screen is installed coaxially within the gel filter tank, with movable upper and lower baffles at both ends. A gel outlet is located at the bottom of the gel filter. A feed inlet and a discharge outlet are located at the upper and lower ends of the side of the gel filter. The gel filter is equipped with an automatic solids stripping system with a differential pressure controller, connected to a pressure sensor and the upper and lower baffles.

[0004] The aforementioned device solves the problems of low efficiency and easy damage to gel particles caused by manual filtration in the prior art. However, the filter inner mesh used in this device may be blocked by gel particles during actual use, affecting the subsequent filtration effect. Therefore, it is necessary to propose a high-efficiency blood product production device and process to solve, to some extent, the problem of the filter inner mesh used in the prior art being blocked by gel particles during actual use, affecting the subsequent filtration effect. Summary of the Invention

[0005] The purpose of this invention is to provide a highly efficient blood product manufacturing apparatus and process, which can, to a certain extent, solve the problem that the filter inner screen used in the prior art may be blocked by gel particles during actual use, affecting the subsequent filtration effect.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: A high-efficiency blood product manufacturing device includes a shell, a first electromagnet fixedly connected to the top wall of the shell, a second electromagnet fixedly connected to the bottom wall of the shell, a magnet ring slidably fitted to the inner side wall of the shell, a filter plate fixedly connected to the inner side wall of the magnet ring, the filter plate dividing the shell into an upper chamber and a lower chamber, a plurality of filter holes being formed on the filter plate, a plurality of upper tubes fixedly connected to the top wall of the filter plate, a plurality of lower tubes fixedly connected to the bottom wall of the filter plate, both the upper and lower tubes communicating with the filter holes, a feed inlet being formed on the top wall of the upper chamber, and a device for sealing the feed inlet being hinged to the side wall of the feed inlet. The upper baffle has a first discharge port on the bottom wall of the lower chamber. A solenoid valve is fixedly connected to the side wall of the first discharge port. The first discharge port is connected to a collection assembly, which includes a collection bottle. A piston is slidably fitted on the inner side wall of the collection bottle. The piston divides the inner wall of the collection bottle into a first chamber and a second chamber. A cylinder is installed in the first chamber. One end of the cylinder is fixedly connected to the top wall of the collection bottle, and the other end of the cylinder is fixedly connected to the top wall of the piston. The second chamber is connected to a first hose. The other end of the first hose is connected to the lower chamber. A second discharge port is opened on the side wall of the upper chamber. A lower baffle for closing the second discharge port is hinged to the side wall of the second discharge port.

[0007] The above scheme achieves the following principles and beneficial effects: When using this device, the upper baffle is opened, and plasma and gel particles are poured into the upper chamber from the inlet. Some plasma enters the lower chamber through the filter holes and the lower tube. The solenoid valve is closed, and the device is started, causing the first and second electromagnets to be alternately energized, thereby driving the magnet ring and filter screen to move up and down reciprocally. This causes the plasma to flow back and forth through the upper and lower tubes within the outer shell. When the gel particles are in full contact with the plasma, the solenoid valve of the first outlet is opened, and the cylinder is activated simultaneously, causing the cylinder to shorten and the pressure in the second chamber to decrease. The plasma in the upper chamber passes through the filter plate and the plasma in the lower chamber together into the second chamber. Then, the lower baffle is opened to remove the gel particles adsorbed with coagulation factors. This device... The upper and lower tubes allow plasma to flow back and forth between the upper and lower chambers during the alternating energization of the first and second electromagnets. This enhances the contact area with the gel particles, thereby increasing the amount of clotting factors adsorbed by the gel particles, improving the yield of the final product, and reducing gel particle waste. Simultaneously, the second electromagnet, as it drives the magnet coil downwards, causes gel particles that might be clogging the filter pores to separate from the filter screen due to inertia. This prevents gel particles from clogging the filter screen and affecting subsequent plasma filtration, thus solving to some extent the problem in existing technologies where the filter inner screen can become clogged by gel particles during actual use, affecting subsequent filtration efficiency.

[0008] Furthermore, it also includes a control system, which includes a controller and several pressure sensors. The pressure sensors are arranged vertically along the inner wall of the housing. The pressure sensors are used to collect pressure information applied by the magnet ring to the inner wall of the housing. The controller is used to control the operation of the first electromagnet and the second electromagnet based on the pressure information.

[0009] Beneficial effects: When using this device, the controller determines the movement trajectory of the magnet ring by the pressure information returned by each pressure sensor. Then, by controlling the current through the first and second electromagnets, the movement speed of the magnet ring is controlled. When the magnet ring moves upward, the speed is slower, reducing the impact on the gel particles and thus reducing damage to the gel particles. When the magnet ring moves downward, the speed is faster, so that the gel particles clogging the filter pores can be more easily removed from the filter plate.

[0010] Furthermore, the ends of both the upper and lower tubes furthest from the filter plate are integrally formed and connected by an arc-shaped bend.

[0011] Beneficial effects: When using this device, as plasma passes through the upper or lower tube, the plasma impacts the upper chamber by passing through the curved tube, causing the gel particles attached to the surface of the filter plate or clogging the filter holes to be impacted. This increases the contact area between the gel particles and the plasma to a certain extent, thereby further increasing the yield of the final product.

[0012] Furthermore, the first chamber is connected to a second flexible tube, which is connected to the upper chamber, and a one-way valve is fixedly connected at the connection between the second flexible tube and the upper chamber.

[0013] Beneficial effects: When using this device, during the process of activating the collection component to extract plasma from the lower chamber, the cylinder contracts, and the gas in the first chamber enters the upper chamber through the second hose, thereby balancing the air pressure inside the outer shell. This, to a certain extent, prevents damage to the gel particles caused by the drop in air pressure inside the outer shell after the plasma enters the second chamber.

[0014] Furthermore, a retaining ring is fixedly connected to the inner wall of the upper chamber formed by the outer shell.

[0015] Beneficial effects: During the use of this device, the retaining ring can prevent the magnet ring from continuing to move upward as the current of the first electromagnet decreases, but the magnet ring continues to move upward at its original speed due to inertia. This further prevents the magnet ring from squeezing the gel particles and causing damage to them. At the same time, during the collision between the magnet ring and the retaining ring, the gel particles continue to move upward due to inertia, thereby further promoting the detachment of the gel particles that are clogging the filter holes from the filter plate.

[0016] Furthermore, a rubber pad is fixedly connected to the bottom of the retaining ring.

[0017] Beneficial effects: When using this device, the rubber pad can cushion the impact of the magnet ring when it collides with the retaining ring, reducing the wear of the magnet ring and retaining ring caused by the impact, thereby extending the service life of the device.

[0018] Furthermore, a high-efficiency blood product manufacturing process is carried out using any one of the high-efficiency blood product manufacturing apparatuses of claims 1-7. The process includes: first, adjusting the pH of the raw plasma to 6.46-6.66 and adding it to the apparatus, simultaneously adding gel particles; second, starting the apparatus to ensure sufficient contact between the raw plasma and the gel particles, allowing coagulation factors to be fully adsorbed by the gel particles, and separating the gel particles adsorbed with coagulation factors; third, adding elution buffer to the gel particles adsorbed with coagulation factors for elution to obtain a crude product; and fourth, subjecting the crude product to S / D virus inactivation, filtering bacteria, and obtaining the blood product. Attached Figure Description

[0019] Figure 1 This is a front cross-sectional view of an embodiment of an efficient blood product manufacturing apparatus and process according to the present invention;

[0020] Figure 2 This is a top cross-sectional view of an embodiment of an efficient blood product manufacturing apparatus and process according to the present invention;

[0021] Figure 3 This is a circuit diagram of an embodiment of a high-efficiency blood product manufacturing apparatus and process according to the present invention;

[0022] Figure 4 This is a process flow diagram of an embodiment of an efficient blood product manufacturing apparatus and process according to the present invention. Detailed Implementation

[0023] The following detailed description illustrates the specific implementation method:

[0024] The reference numerals in the accompanying drawings include: outer casing 1, lower chamber 11, upper chamber 12, second electromagnet 2, filter plate 3, lower tube 31, upper tube 32, bend 33, magnet ring 4, collection assembly 5, first hose 51, second chamber 52, piston 53, cylinder 54, first chamber 55, collection bottle 56, second hose 57, lower baffle 6, upper baffle 7, first electromagnet 8, retaining ring 9, and rubber pad 91.

[0025] Example 1

[0026] The basic implementation examples are as follows: Figure 1-4 As shown:

[0027] A high-efficiency blood product manufacturing device includes a shell 1. A first electromagnet 8 is bolted to the top wall of the inner shell 1, and a second electromagnet 2 is bolted to the bottom wall of the inner shell 1. A magnet ring 4 is slidably fitted onto the inner side wall of the shell 1. A filter plate 3 is welded to the inner side wall of the magnet ring 4, dividing the inner shell 1 into an upper chamber 12 and a lower chamber 11. The filter plate 3 has several filter holes. Several upper tubes 32 are welded to the top wall of the filter plate 3, and several lower tubes 31 are welded to the bottom wall of the filter plate 3. Both the upper tubes 32 and the lower tubes 31 communicate with the filter holes. An inlet is opened on the top wall of the upper chamber 12, and an upper baffle 7 for closing the inlet is hinged to the side wall of the inlet. A first outlet is opened on the bottom wall of the lower chamber 11. A solenoid valve is fixedly connected to the wall by bolts. The first discharge port is connected to a collection assembly 5, which includes a collection bottle 56. A piston 53 is slidably fitted on the inner wall of the collection bottle 56. The piston 53 divides the inner wall of the collection bottle 56 into a first chamber 55 and a second chamber 52. A cylinder 54 is provided in the first chamber 55. The preferred model of the cylinder 54 is CDJ2B10-15-B. One end of the cylinder 54 is fixedly connected to the inner top wall of the collection bottle 56 by bolts, and the other end of the cylinder 54 is bonded and fixed to the top wall of the piston 53. The second chamber 52 is connected to a first hose 51. The other end of the first hose 51 is connected to the lower chamber 11. A second discharge port is opened on the side wall of the upper chamber 12. A lower baffle 6 for closing the second discharge port is hinged to the side wall of the second discharge port.

[0028] The specific implementation process is as follows: When using this device, open the upper baffle 7, pour the plasma and gel particles into the upper chamber 12 from the feed port respectively, and some plasma enters the lower chamber 11 through the filter hole and the lower tube 31. Close the solenoid valve, start the device, and make the first electromagnet 8 and the second electromagnet 2 alternately energized.

[0029] When the second electromagnet 2 is de-energized, the first electromagnet 8 is energized. The first electromagnet 8 attracts the magnet ring 4, causing the magnet ring 4 and the filter screen to move upward. The volume of the upper chamber 12 decreases, and the filter plate 3 squeezes the blood plasma in the upper chamber 12, allowing the blood plasma to enter the lower chamber 11 through the filter hole and the lower tube 31.

[0030] Then the first electromagnet 8 is de-energized and the second electromagnet 2 is energized. The second electromagnet 2 attracts the magnet ring 4, causing the magnet ring 4 and the filter screen to move downwards. The volume of the lower chamber 11 decreases, and the filter plate 3 squeezes the blood plasma in the lower chamber 11, so that the blood plasma enters the upper chamber 12 through the filter hole and the upper tube 32.

[0031] After the gel particles come into full contact with the plasma, the solenoid valve of the first outlet is opened, and the cylinder 54 is activated at the same time, which shortens the cylinder 54 and reduces the pressure in the second chamber 52. Under the action of air pressure, the plasma in the upper chamber 12 passes through the filter plate 3 and the plasma in the lower chamber 11 and enters the second chamber 52 together. Then the lower baffle 6 is opened to remove the gel particles adsorbed with coagulation factors.

[0032] This device, through the arrangement of the upper tube 32 and the lower tube 31, allows plasma to flow back and forth between the upper chamber 12 and the lower chamber 11 during the alternating energization of the first electromagnet 8 and the second electromagnet 2. This enhances the contact area with the gel particles, thereby increasing the number of coagulation factors adsorbed by the gel particles to a certain extent, improving the yield of the final product, and reducing the waste of gel particles. At the same time, the second electromagnet 2, during the downward movement of the magnet coil driven by the second electromagnet 2, causes gel particles that may be blocked in the filter holes to separate from the filter screen due to inertia, preventing gel particles from clogging the filter screen and affecting the subsequent filtration of plasma.

[0033] Example 2

[0034] The difference from the above embodiments is that it also includes a control system, which includes a controller and several pressure sensors. The controller is preferably a 2080Micro850, and the pressure sensors are preferably AST2000. The pressure sensors are all fixedly connected to the inner wall of the housing 1 by bolts, and the pressure sensors are arranged vertically along the inner wall of the housing 1. The controller is fixedly connected to the outer wall of the housing 1 by bolts. The pressure sensors are used to collect the pressure information applied by the magnet ring 4 to the inner wall of the housing 1. The controller is used to control the operation of the first electromagnet 8 and the second electromagnet 2 according to the pressure information.

[0035] The specific implementation process is as follows: When using this device, the pressure sensor continuously transmits the pressure information of the magnet ring 4 applied to the inner wall of the outer shell 1 to the controller. The controller judges the movement trajectory of the magnet ring 4 by the pressure information changes of each pressure sensor. When the magnet ring 4 moves upward too fast, the controller reduces the current through the first electromagnet 8, so that the magnetic force between the first electromagnet 8 and the magnet ring 4 decreases. Under the action of the resistance of the plasma, the upward movement speed of the magnet ring 4 is slowed down, thereby avoiding the magnet ring 4 moving too fast and impacting the gel particles, thus damaging the gel particles. When the magnet ring moves downward too slowly, the controller increases the current through the second electromagnet 2, so that the magnetic force between the second electromagnet 2 and the magnet ring 4 increases, thereby offsetting part of the resistance generated by the plasma, so that the magnet ring 4 can move downward quickly, so that the gel particles clogging the filter holes can be more easily removed from the filter plate 3.

[0036] Example 3

[0037] The difference from the above embodiment is that the ends of the upper tube 32 and the lower tube 31 that are away from the filter plate 3 are integrally formed and connected to an arc-shaped bend 33.

[0038] The specific implementation process is as follows: When using this device, when the plasma passes through the upper tube 32 or the lower tube 31, the plasma impacts the surface of the filter plate 3 through the bent tube 33, causing the gel particles attached to the surface of the filter plate 3 or blocking the filter holes to be impacted into the upper chamber 12, which to a certain extent increases the contact area between the gel particles and the plasma, thereby further increasing the yield of the final product.

[0039] Example 4

[0040] The difference from the above embodiment is that: the first chamber 55 is connected to the second hose 57, the second hose 57 is connected to the upper chamber 12, and a one-way valve is fixedly connected to the connection between the second hose 57 and the upper chamber 12 by bolts. The one-way valve is preferably NRV-06.

[0041] The specific implementation process is as follows: When using this device, during the process of activating the collection component 5 to extract plasma from the lower chamber 11, the cylinder 54 contracts, the air pressure in the second chamber 52 decreases, and the air pressure in the first chamber 55 increases. The gas in the first chamber 55 enters the upper chamber 12 through the second hose 57, thereby balancing the air pressure inside the outer shell 1. This, to a certain extent, prevents the plasma inside the outer shell 1 from entering the second chamber 52 and causing damage to the gel particles due to the decrease in air pressure inside the outer shell 1.

[0042] Example 5

[0043] The difference from the above embodiment is that a retaining ring 9 is welded and fixed on the inner wall of the upper chamber 12 of the outer shell 1.

[0044] The specific implementation process is as follows: When the magnet ring 4 moves upward too fast during the use of this device, which may damage the gel particles, the controller reduces the current passing through the first electromagnet 8. Due to inertia, the magnet ring 4 may maintain its original speed and continue to move upward for a certain distance. The retaining ring 9 can prevent the magnet ring 4 from continuing to move upward at this time, further preventing the magnet ring 4 from squeezing the gel particles and causing damage to the gel particles. At the same time, during the collision between the magnet ring 4 and the retaining ring 9, due to inertia, the gel factor continues to move upward, thereby further promoting the gel factor that is clogging the filter holes to detach from the filter plate 3.

[0045] Example 6

[0046] The difference from the above embodiment is that a rubber pad 91 is glued and fixed to the bottom of the retaining ring 9, and the rubber pad 91 is preferably made of silicone.

[0047] The specific implementation process is as follows: When using this device, when the magnet ring 4 collides with the retaining ring 9, the rubber pad 91 can convert the kinetic energy of the magnet ring 4 into its own elastic potential energy, thereby buffering the impact of the magnet ring 4 and reducing the wear of the magnet ring 4 and the retaining ring 9 caused by the impact, thus extending the service life of this device.

[0048] Example 7

[0049] The difference from the above embodiments is as follows: the high-efficiency blood product production process using the above-mentioned high-efficiency blood product production device involves the following steps: First, adjusting the pH of the raw plasma to 6.46-6.66 and adding it to the device, while simultaneously adding gel particles; Second, starting the device to ensure sufficient contact between the raw plasma and the gel particles, allowing coagulation factors to be fully adsorbed by the gel particles, and then separating the gel particles adsorbed with coagulation factors; Third, adding elution buffer to the gel particles adsorbed with coagulation factors for elution to obtain a crude product; Fourth, subjecting the crude product to S / D virus inactivation, filtering bacteria, and obtaining the blood product.

[0050] The above descriptions are merely embodiments of the present invention. Commonly known structures and characteristics are not described in detail here. Those skilled in the art are aware of all common technical knowledge in the field prior to the application date or priority date, are aware of all existing technologies in that field, and have the ability to apply conventional experimental methods prior to that date. Those skilled in the art can, under the guidance of this application, improve and implement this solution in combination with their own capabilities. Some typical known structures or methods should not be obstacles for those skilled in the art to implement this application. It should be noted that those skilled in the art can make several modifications and improvements without departing from the structure of the present invention. These should also be considered within the scope of protection of the present invention, and will not affect the effectiveness of the implementation of the present invention or the practicality of the patent. The scope of protection claimed in this application should be determined by the content of its claims, and the specific embodiments described in the specification can be used to interpret the content of the claims.

Claims

1. A high-efficiency blood product manufacturing apparatus, characterized in that: The device includes an outer shell. A first electromagnet is fixedly connected to the top wall of the inner shell, and a second electromagnet is fixedly connected to the bottom wall of the inner shell. A magnetic ring is slidably fitted onto the inner side wall of the outer shell, and a filter plate is fixedly connected to the inner side wall of the magnetic ring. The filter plate divides the inner shell into an upper chamber and a lower chamber. The filter plate has several filter holes. Several upper tubes are fixedly connected to the top wall of the filter plate, and several lower tubes are fixedly connected to the bottom wall of the filter plate. Both the upper and lower tubes are connected to the filter holes. An inlet is opened on the top wall of the upper chamber, and an upper baffle for closing the inlet is hinged to the side wall of the inlet. A first outlet is opened on the bottom wall of the lower chamber, and a solenoid valve is fixedly connected to the side wall of the first outlet. The first outlet is connected to a collection component for absorbing plasma from the inner shell. A second outlet is opened on the side wall of the upper chamber, and a lower baffle for closing the second outlet is hinged to the side wall of the second outlet.

2. The high-efficiency blood product manufacturing apparatus according to claim 1, characterized in that: It also includes a control system, which includes a controller and several pressure sensors. The pressure sensors are arranged vertically along the inner wall of the housing. The pressure sensors are used to collect pressure information applied by the magnet ring to the inner wall of the housing. The controller is used to control the operation of the first electromagnet and the second electromagnet based on the pressure information.

3. The high-efficiency blood product manufacturing apparatus according to claim 2, characterized in that: The ends of both the upper and lower tubes away from the filter plate are integrally formed and connected by an arc-shaped bend.

4. The high-efficiency blood product manufacturing apparatus according to claim 3, characterized in that: The collection assembly includes a collection bottle, with a piston slidably fitted on the inner wall of the collection bottle. The piston divides the inner wall of the collection bottle into a first chamber and a second chamber. A cylinder is installed in the first chamber, with one end of the cylinder fixedly connected to the top wall of the collection bottle and the other end of the cylinder fixedly connected to the top wall of the piston. The second chamber is connected to a first flexible tube, with the other end of the first flexible tube connected to the lower chamber.

5. The high-efficiency blood product manufacturing apparatus according to claim 4, characterized in that: The first chamber is connected to a second flexible tube, which is connected to the upper chamber. A one-way valve is fixedly connected at the connection between the second flexible tube and the upper chamber.

6. The high-efficiency blood product manufacturing apparatus according to claim 5, characterized in that: A retaining ring is fixedly connected to the inner wall of the upper chamber formed by the outer shell.

7. The high-efficiency blood product manufacturing apparatus according to claim 6, characterized in that: A rubber pad is fixedly connected to the bottom of the retaining ring.

8. A highly efficient blood product manufacturing process, characterized in that: The process is carried out using any one of the high-efficiency blood product manufacturing apparatuses according to claims 1-7. The first step involves adjusting the pH of the raw plasma to 6.46-6.66 and adding it to the apparatus, simultaneously adding gel particles. The second step involves starting the apparatus, allowing the raw plasma and gel particles to come into full contact, enabling the coagulation factors to be fully adsorbed by the gel particles, and separating the gel particles adsorbed with the coagulation factors. The third step involves adding elution buffer to the gel particles adsorbed with the coagulation factors for elution, obtaining a crude product. The fourth step involves inactivating the crude product with S / D viruses, filtering bacteria, and obtaining the blood product.

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