A virus inactivation system and method

Abstract

This invention relates to a virus inactivation system and method. The virus inactivation system includes a container, a squeezing device, an ultraviolet lamp assembly, and an isolation chamber. The squeezing device includes a first squeezing member and a second squeezing member that can move closer or further apart and allow ultraviolet light to pass through. When the first squeezing member and the second squeezing member move closer together, the container deforms under the pressure exerted by the first squeezing member and the second squeezing member. The ultraviolet lamp assembly includes multiple ultraviolet lamps emitting UVC wavelengths. The isolation chamber includes a chamber body and a door that can be opened and closed. The container, the first squeezing member, the second squeezing member, and the ultraviolet lamp assembly are installed inside the chamber body. The virus inactivation system and method of this invention have advantages such as broad-spectrum inactivation with stable inactivation effect, no need for additional photosensitizers, high retention rate of active ingredients, short inactivation time, convenient operation, and good biocompatibility.

Description

Technical Field

[0001] This invention belongs to the field of virus inactivation in the biological industry, specifically relating to a virus inactivation system and method suitable for liquid biological products, particularly a virus inactivation system and method suitable for blood products. Background Technology

[0002] This section is intended to provide background or context for the embodiments of the invention set forth in the claims. The description herein is not an admission that it is prior art simply because it is included in this section.

[0003] Ensuring the safety of blood products is a crucial cornerstone of the public health system, and safety is a prerequisite for clinical transfusion therapy. Virus inactivation is listed as a mandatory step in blood processing, and its necessity is reflected in the following aspects:

[0004] Limitations of traditional screening techniques: Although serological screening (ELISA / NAT test) for pathogens such as HBV, HCV, and HIV is required before blood transfusion, the following factors still lead to residual risks: (1) the virus is in the window period, resulting in missed detection; (2) the detection sensitivity threshold is higher than the pathogenicity threshold; (3) in addition to the viruses that are routinely required to be detected, there are emerging viruses that are not included in routine screening, such as SARS-CoV-2 and Zika virus.

[0005] The irreplaceable nature of virus inactivation technology: Virus inactivation technology directly destroys pathogens through physical or chemical means, which can make up for the shortcomings of screening technology. It has a wide inactivation range (it is completely or partially effective against known / unknown viruses with different physical and chemical properties) and strong risk control capabilities (it can reduce the risk of virus transmission through blood transfusion from 1 / 500,000 to <1 / 10,000,000, which depends solely on screening).

[0006] The "Technical Operating Procedures for Blood Banks (2019 Edition)" clearly stipulates three methods for inactivating pathogens in blood components: methylene blue photochemical method, riboflavin photochemical method, and psoralen (S-59) photochemical method. Among them, the methylene blue photochemical method uses the combination of methylene blue and visible light to inactivate enveloped viruses (4-5 log) in plasma. However, this method results in a loss of approximately 38% of coagulation factor VIII, and requires nanofiltration to remove residues, leading to another 15% loss of plasma. The processing time for this method is approximately 90 minutes per unit. The riboflavin photochemical method uses the combination of riboflavin and UV light to inactivate both enveloped and non-enveloped viruses (5-6 log) in plasma or platelets. However, this method leads to a decrease of approximately 25% in fibrinogen in blood products, and the processing time is approximately 45 minutes per unit. The psoralen (S-59) photochemical method utilizes the synergy of psoralen (S-59) and UVA to inactivate enveloped viruses (>6 log) in plasma or platelets. This method exhibits an approximately 15% IgG polymerization rate and requires the use of an adsorption column to remove S-59. The processing time is approximately 60 minutes per unit. Therefore, these three virus inactivation methods suffer from several drawbacks: poor inactivation efficacy against non-lipid-enveloped viruses, long processing times, unsuitability for emergency transfusion scenarios, the need for additional filtration processes to remove chemical substances, potential chemical toxicity risks, and high costs of photosensitizers.

[0007] Traditional methods for inactivating viruses in biological products include low pH methods, organic solvent / detergent (S / D) methods, nanofiltration, chromatography, pasteurization, and photochemical methods. These methods have drawbacks such as high cost, effectiveness only against lipid-enveloped viruses, genotoxicity, and the fact that optimal inactivation conditions vary depending on the composition of the biological product.

[0008] Ultraviolet (UV) disinfection is a physical method for virus inactivation. However, current devices using this principle for virus inactivation have several drawbacks: protein-based biological samples absorb UV light, making it difficult for light to penetrate thick biological liquids. Proteins easily denature and coagulate on the container walls, leading to a sharp decrease in light transmittance, uneven inactivation efficiency, low protein recovery, and potential genotoxicity. For example, when using transparent containers made of quartz or polymer materials to hold liquid biological products during virus inactivation, inadequate or untimely cleaning can cause large protein molecules to denature and adhere to the container walls, resulting in high cleaning and disinfection costs. Furthermore, the devices themselves require time-consuming cleaning and disinfection processes after startup.

[0009] Therefore, there is an urgent need to develop a virus inactivation system and method with high processing efficiency, good virus inactivation effect and high protein retention rate. Summary of the Invention

[0010] The purpose of this invention is to provide a virus inactivation system and method with high processing efficiency, good virus inactivation effect and high protein retention rate.

[0011] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0012] The first aspect of this invention provides a virus inactivation system, comprising:

[0013] A container for holding biological products to be inactivated with viruses, the container having an opening that can be opened and closed, the container allowing ultraviolet light to pass through, being deformable under pressure, and being biocompatible.

[0014] An extrusion device includes a first extruder and a second extruder that can move closer or further apart and allow ultraviolet light to pass through. When the first extruder and the second extruder move closer together, the container is deformed by the pressure applied by the first extruder and the second extruder. The surfaces of the first extruder and the second extruder that are in contact with the container are planar and the area of ​​the surfaces is greater than or equal to the maximum area of ​​the container after deformation.

[0015] An ultraviolet lamp assembly comprising a plurality of ultraviolet lamps emitting UVC bands, wherein the plurality of ultraviolet lamps are respectively located on the side of the first extruder and the second extruder away from the container;

[0016] An isolation chamber, comprising a chamber body and a door that can be opened and closed, wherein the container, the first extruder, the second extruder, and the ultraviolet lamp assembly are installed within the chamber body.

[0017] The maximum area here refers to the surface area of ​​one surface of the container after deformation.

[0018] According to some specific implementations, the container is a disposable container.

[0019] According to some specific embodiments, the thickness of the container after being compressed by the first extruder and the second extruder is 0.02 cm to 2 cm, preferably 0.02 cm to 0.5 cm.

[0020] According to some specific embodiments, the capacity of the container is from 100 ml to 400 ml.

[0021] According to some specific embodiments, the container is bag-shaped. Further, the container is a square flat bag or a round flat bag.

[0022] According to some specific embodiments, the single-layer wall thickness of the container is from 0.20 mm to 0.75 mm.

[0023] According to some specific embodiments, the UVC transmittance of the container is above 80%.

[0024] According to some specific embodiments, the container is made of fluoropolymer, polyolefin, or other special engineering plastics.

[0025] According to some specific embodiments, the container is placed horizontally when the virus inactivation system performs virus inactivation.

[0026] According to some specific embodiments, when the first extruder and the second extruder are close to each other to the closest possible state, the distance between the first extruder and the second extruder is 0.02 cm to 2 cm, preferably 0.02 cm to 0.5 cm.

[0027] According to some specific embodiments, the first extruder and the second extruder are made of quartz.

[0028] According to some specific embodiments, the first extruder and the second extruder are in the shape of flat plates.

[0029] According to some specific embodiments, the thickness of the first extruder and the second extruder is 0.1 cm to 0.5 cm.

[0030] According to some specific embodiments, the upper and lower surfaces of the first extruder and the second extruder are square.

[0031] According to some specific embodiments, the extrusion device further includes a transmission component connected to the first extruder and / or the second extruder and capable of driving the first extruder and the second extruder to move closer or further apart, and a power source connected to the transmission component and capable of driving the transmission component to move.

[0032] Furthermore, the first extrusion member is located below the second extrusion member, the first extrusion member is fixedly connected to the cabin body, and the second extrusion member is connected to the transmission assembly and can move in the vertical direction under the drive of the transmission assembly.

[0033] Furthermore, the transmission assembly includes a screw with one end connected to and driven to rotate by the power source, a nut mounted on and cooperating with the screw, and a connecting rod fixedly connected to the nut. The connecting rod is fixedly disposed relative to the second extrusion member, and the other end of the screw is rotatably mounted on the cabin.

[0034] Furthermore, the power source, the screw, and the nut are located inside or outside the cabin. When the power source, the screw, and the nut are located outside the cabin, a first sliding groove extending in the vertical direction is provided on the outer wall of the cabin, and the connecting rod is inserted into the first sliding groove.

[0035] Furthermore, the number of connecting rods and the first grooves is two or more and they are evenly distributed along the width direction of the second extruder.

[0036] Furthermore, the transmission assembly and the power source are respectively two sets symmetrically arranged on the left and right sides of the second extruder.

[0037] Furthermore, the power source is an electric motor.

[0038] According to some specific embodiments, the extrusion device further includes a first mounting bracket fixedly connected to the first extruder and the chamber respectively, a second mounting bracket fixedly connected to the second extruder, a first support member whose lower end is rotatably connected to the first mounting bracket and whose upper end is rotatably and slidably connected to the second mounting bracket, and a second support member whose lower end is rotatably and slidably connected to the first mounting bracket and whose upper end is rotatably connected to the second mounting bracket; the first support member and the second support member are rotatably connected.

[0039] Furthermore, the first support member and the second support member are two sets symmetrically arranged on the left and right sides of the second extruder.

[0040] Furthermore, the first mounting bracket and the second mounting bracket are respectively provided with second sliding grooves extending in the front-rear direction. The first extruder and the second extruder are respectively provided with protrusions inserted into the second sliding grooves and capable of sliding in the second sliding grooves. When the first extruder and the second extruder are close to each other to the closest state, the protrusions on the first support and the second support are respectively located on the outermost side of the second sliding groove.

[0041] Furthermore, the lower ultraviolet lamp is fixedly mounted on the bottom surface of the first mounting bracket or the cabin, or movable in the vertical direction, while the upper ultraviolet lamp is fixedly mounted on the second mounting bracket, or movable in the vertical direction.

[0042] According to some specific embodiments, the distance between the lower ultraviolet lamp and the first extruder is 5 cm to 20 cm, and the distance between the upper ultraviolet lamp and the second extruder is 5 cm to 20 cm.

[0043] According to some specific embodiments, the projections of the upper ultraviolet lamp and the lower ultraviolet lamp on the horizontal plane are staggered, and the staggered distance between two adjacent ultraviolet lamps is equal.

[0044] According to some specific embodiments, the average UV intensity of one side surface of the container is 2000-5000 μW / cm. 2 .

[0045] According to some specific embodiments, the outer surface of the ultraviolet lamp is formed with an explosion-proof filter film capable of filtering out ultraviolet rays with wavelengths other than 254±5nm.

[0046] According to some specific embodiments, the virus inactivation device further includes a first light-blocking curtain disposed between the lower ultraviolet lamp and the first extruder and capable of being opened and rolled up, and a second light-blocking curtain disposed between the upper ultraviolet lamp and the second extruder and capable of being opened and rolled up; when the first light-blocking curtain and the second light-blocking curtain are in the open state, the first light-blocking curtain and the second light-blocking curtain prevent ultraviolet light from irradiating the container; when the first light-blocking curtain and the second light-blocking curtain are in the rolled-up state, the container is exposed to ultraviolet radiation.

[0047] Furthermore, the virus inactivation device also includes a drive device that is connected to the first light-blocking curtain and the second light-blocking curtain respectively and is capable of driving the first light-blocking curtain and the second light-blocking curtain to automatically retract.

[0048] According to some specific embodiments, when the door is closed, the isolation chamber is in a sealed state, and the virus inactivation system also includes a vacuuming device connected to the chamber and capable of evacuating the chamber.

[0049] According to some specific embodiments, the virus inactivation system also includes a temperature probe, a UV irradiation probe, an induction timer, and a workbench for controlling the operation of the virus inactivation system, all installed inside the cabin.

[0050] According to some specific embodiments, the container opening includes an inlet on one side and an outlet on the other side. The virus inactivation system also includes an inlet pipe integrally formed with the inlet of the container, an outlet pipe integrally formed with the outlet of the container, a first storage tank connected to the inlet pipe and used for storing the biological product before inactivation, a second storage tank connected to the outlet pipe and used for storing the biological product after inactivation, and peristaltic pumps respectively provided on the inlet pipe and the outlet pipe; the container, the inlet pipe and the outlet pipe are all disposable consumables.

[0051] Furthermore, the isolation chamber includes multiple separate sub-chambers, each sub-chamber having a corresponding door, and each sub-chamber having a corresponding container, the squeezing device, and the ultraviolet lamp assembly; the liquid inlet pipe includes a main liquid inlet pipe connected to the first storage tank and multiple branch liquid inlet pipes integrally formed with the inlet of each container, the multiple branch liquid inlet pipes being connected to the main liquid inlet pipe; the liquid outlet pipe includes a main liquid outlet pipe connected to the second storage tank and multiple branch liquid outlet pipes integrally formed with the outlet of each container, the multiple branch liquid outlet pipes being connected to the main liquid outlet pipe, and the peristaltic pump is respectively installed on the main liquid inlet pipe and the main liquid outlet pipe.

[0052] According to some specific embodiments, the biological product is a liquid biological product; further, the liquid biological product is a vaccine preparation, toxin preparation, toxoid preparation, immune serum, blood product, immunoglobulin preparation, antigen preparation, allergen preparation, cytokine preparation, hormone preparation, enzyme product, fermentation broth, monoclonal antibody preparation, or in vitro immunodiagnostic product; even further, the biological product is a blood product.

[0053] According to some specific embodiments, the virus includes one or more of the following families: Reoviridae, Rhabdoviridae, Orthomyxoviridae, Filoviridae, Coronaviridae, Bunyaviridae, Bonaviviridae, Flaviviridae, Paramyxoviridae, Clonorviridae, Arenaviridae, Microribonucleoviridae, Caliciviridae, Retroviridae, Poxviridae, Herpesviridae, Iridoviridae, Papillomaviridae, and Parvoviridae.

[0054] The second aspect of the present invention provides a method for virus inactivation, which uses the virus inactivation system described above to inactivate the biological products containing the virus to be inactivated. After completing the virus inactivation of one batch of biological products, a new container is used to inactivate the next batch of biological products.

[0055] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art:

[0056] The virus inactivation system and method of the present invention have the advantages of broad-spectrum inactivation and stable inactivation effect, no need to add photosensitizer, so no additional filtration step is required to remove photosensitizer and its residues, high retention rate of active ingredients, short inactivation time, convenient operation, and good biocompatibility. Attached Figure Description

[0057] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0058] Figure 1 A perspective view of the virus inactivation system according to the first embodiment;

[0059] Figure 2 This is a front view of the virus inactivation system according to the first embodiment;

[0060] Figure 3 A side view of the virus inactivation system according to the first embodiment;

[0061] Figure 4 A top view of the virus inactivation system according to the first embodiment;

[0062] Figure 5 This is an internal structural diagram of the virus inactivation system according to the first embodiment with the hatch open.

[0063] Figure 6 This is an internal structural diagram of the virus inactivation system according to the first embodiment, with the hatch open and some parts of the cabin omitted.

[0064] Figure 7 A side view of the virus inactivation system according to the first embodiment with the hatch open and part of the cabin omitted;

[0065] Figure 8 A front view of the container being flattened by the first and second extruders;

[0066] Figure 9 A perspective view of the virus inactivation system according to the third implementation method;

[0067] Figure 10 This is a front view of the virus inactivation system according to the third implementation method;

[0068] Figure 11 A top view of the virus inactivation system according to the third implementation method;

[0069] Figure 12 A side view of the virus inactivation system according to the third embodiment;

[0070] Figure 13 A three-dimensional view (first-person perspective) of the internal structure of the virus inactivation system in the third embodiment with the hatch open;

[0071] Figure 14A front view of the internal structure of the virus inactivation system according to the third embodiment with the hatch open;

[0072] Figure 15 A perspective view (second view) of the internal structure of the virus inactivation system in the third embodiment with the hatch open;

[0073] Figure 16 A perspective view (second view) of the internal structure of the virus inactivation system of the third embodiment with the hatch open and some parts of the cabin omitted;

[0074] The components are as follows: 1. Container; 2. Extrusion device; 3. UV lamp assembly; 4. Isolation chamber; 5. First mounting bracket; 6. Second mounting bracket; 7. First support member; 8. Second support member; 9. Second chute; 10. Protrusion; 11. First shading curtain; 12. Second shading curtain; 13. Workbench; 21. First extrusion member; 22. Second extrusion member; 23. Power source; 24. Screw; 25. Nut; 26. Connecting rod; 31. UV lamp; 41. Chamber body; 42. Chamber door; 43. First chute; 44. Sub-chamber body; 51. Inlet main pipe; 52. Inlet branch pipe; 53. First storage tank; 54. Outlet main pipe; 55. Outlet branch pipe; 56. Second storage tank; 57. Peristaltic pump. Detailed Implementation

[0075] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the embodiments of the invention. Therefore, the drawings and description are considered to be exemplary in nature and not restrictive.

[0076] All features disclosed in this invention, or steps in all methods or processes disclosed, may be combined in any way, except for mutually exclusive features or steps.

[0077] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with specific embodiments. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Unless specifically stated, they can be replaced by other equivalent or similar alternative features. Unless specifically stated, each feature is only one example of a series of equivalent or similar features. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Therefore, the detailed description of the embodiments of the present invention provided below is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the invention.

[0078] Unless otherwise specified, the terminology used in this invention generally has the meanings commonly understood by those skilled in the art. The implementation conditions used in the embodiments can be further adjusted according to different specific requirements; implementation conditions not specified are conventional conditions in the industry. The technical features involved in the various embodiments of this invention can be combined with each other as long as they do not conflict with each other.

[0079] In the description of this invention, it should be understood that directional terms such as up, down, left, right, inside, and outside are used in conjunction with... Figure 5 Define the orientation. Figure 5 Above is "up," below is "down," left is "left," right is "right," and the position closest to the system center is "inner." The above description of directional terms is only for the convenience of describing the embodiments of the present invention and simplifying the description, and is not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of the present invention.

[0080] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of embodiments of the present invention, "multiple" means two or more, unless otherwise explicitly specified.

[0081] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of this invention according to the specific circumstances.

[0082] The following disclosure provides many different implementations or examples for carrying out different structures of the embodiments of the present invention. To simplify the disclosure of the embodiments of the present invention, specific examples of components and arrangements are described below. Of course, these are merely examples and are not intended to limit the embodiments of the present invention. Furthermore, reference numerals and / or reference letters may be repeated in different examples of the embodiments of the present invention; such repetition is for simplification and clarity and does not in itself indicate a relationship between the various implementations and / or arrangements discussed.

[0083] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0084] Figures 1 to 4 The external structure of the virus inactivation system in the first embodiment is shown. Figures 5 to 7 The internal structure of the virus inactivation system in this embodiment is shown.

[0085] The virus inactivation system in this embodiment includes a container 1, a squeezing device 2, an ultraviolet lamp assembly 3, and an isolation chamber 4, etc. Figures 1 to 4 As shown, the isolation chamber 4 includes a chamber body 41 and a door 42 that can be opened and closed (the door handle and the connection structure that allows the door to be opened are not shown in the figure). The chamber body 41 and the door 42 together form a space that can accommodate the container 1, the first extrusion member 21, the second extrusion member 22 and the ultraviolet lamp assembly 3. The installation method of the door 42 can adopt existing technology.

[0086] like Figures 5 to 8 As shown, container 1 has an opening that can be opened and closed (not shown in the figure). When the opening is open, biological products to be inactivated are placed into container 1 through the opening or biological products after virus inactivation are transferred to other storage devices through the opening. When the opening is closed, the biological products in container 1 cannot flow out of the opening.

[0087] The container 1 allows ultraviolet light to pass through, thus enabling ultraviolet light to penetrate the container 1 and inactivate viruses in the biological product when exposed to ultraviolet light. The container 1 is biocompatible, thereby preventing non-compliance of the container 1 from affecting the quality of the biological product.

[0088] The container 1 can deform under pressure, so that when the extrusion device 2 squeezes the container 1, it can be flattened without breaking. When the container 1 is flattened, the thickness of the biological product inside the container 1 is uniform, which is beneficial to the uniformity of virus inactivation and the uniformity of inactivation efficiency at each location, and avoids local protein denaturation and coagulation on the wall of the container 1. Furthermore, the thickness of the container 1 after compression is 0.02 cm to 2 cm, further 0.02 cm to 0.5 cm, for example 0.02 cm, 0.04 cm, 0.06 cm, 0.08 cm, 0.1 cm, 0.12 cm, 0.14 cm, 0.16 cm, 0.18 cm, 0.2 cm, 0.22 cm, 0.24 cm, 0.26 cm, 0.28 cm, 0.3 cm, 0.32 cm, 0.34 cm, 0.36 cm, 0.38 cm, 0.4 cm, 0.42 cm, 0.44 cm, 0.46 cm, 0.48 cm, and 0.5 cm. Even further, the thickness of the container 1 after compression is 0.02 cm to 0.4 cm. 1. When the absorbance of the biological product does not change significantly, the smaller the thickness of container 1 after compression, the higher the transmittance, the shorter the light path length, and the shorter the inactivation time under the same UV irradiation intensity. 2. When the absorbance of the biological product increases, the thickness of container 1 after compression decreases, the light path length shortens, and the transmittance reaches the rated proportion to achieve the same inactivation time while still providing sufficient illuminance.

[0089] The container 1 has a capacity of 100 ml to 400 ml. When container 1 is compressed to a thickness of 0.02 cm to 0.5 cm, under moderate tension, the maximum extended surface area is approximately 0.02 m² to 4 m². Specifically, for a 100 ml container, when compressed to a thickness of 0.02 cm, the surface area of ​​container 1 is approximately 0.5 m², and when compressed to a thickness of 0.5 cm, the surface area of ​​container 1 is approximately 0.02 m². For a 200 ml container, when compressed to a thickness of 0.02 cm, the surface area of ​​container 1 is approximately 2 m², and when compressed to a thickness of 0.5 cm, the surface area of ​​container 1 is approximately 0.1 m². For a 300 ml container, when compressed to a thickness of 0.02 cm, the surface area of ​​container 1 is approximately 3 m², and when compressed to a thickness of 0.5 cm, the surface area of ​​container 1 is approximately 0.15 m². A container with a capacity of 400 ml, when squeezed to a thickness of 0.02 cm, has a surface area of ​​approximately 4 square meters; when squeezed to a thickness of 0.5 cm, the surface area of ​​container 1 is approximately 0.21 square meters.

[0090] Container 1 is a disposable container. After the virus inactivation of a single sample or batch of biological products is completed, a new container 1 is replaced to avoid cross-contamination between biological products. It can also save the step of cleaning and sterilizing container 1, save processing time, and improve processing efficiency.

[0091] The container 1 can be any shape that can be uniformly expanded after being compressed. In some embodiments, the container 1 is bag-shaped. Further, the container 1 is a square flat bag or a round flat bag. When the container 1 is compressed, it can expand uniformly in all directions. The following uses a square flat bag as an example to illustrate the size and variations of the container: Taking a 200 ml container as an example, when the square flat bag is compressed to a thickness of 0.02 cm, the area occupied by container 1 is approximately 1 square meter, and the side length is approximately 1 meter. When the square flat bag is compressed to a thickness of 0.5 cm, the area occupied by container 1 is approximately 0.05 square meters, and the side length is approximately 22 cm. Taking a 300 ml container as an example, when the square flat bag is compressed to a thickness of 0.02 cm, the area occupied by container 1 is approximately 1.5 square meters, and the side length is approximately 1.22 meters. When the square flat bag is compressed to a thickness of 0.5 cm, the area occupied by container 1 is approximately 0.075 square meters, and the side length is approximately 27 cm. Taking a 400 ml container as an example, when the square flat bag is compressed to a thickness of 0.02 cm, the area occupied by container 1 is about 2 square meters and the side length is about 1.41 meters. When the square flat bag is compressed to a thickness of 0.5 cm, the area occupied by container 1 is about 0.1 square meters and the side length is about 32 cm.

[0092] The single-layer wall thickness of container 1 is 0.20 mm to 0.75 mm to ensure UV transmittance and prevent breakage after extrusion, with moderate tension. The material of container 1 is selected for its good extensibility, tear resistance, transparency (facilitating observation of the contents' sedimentation and properties), and UVC transmittance of over 80%, such as fluoropolymers, polyolefins, or other special engineering plastics. Specifically, these include fluoropolymers such as FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxy), and ETFE (ethylene tetrafluoroethylene); polyolefins such as COP (cyclic olefin polymer) and COC (cyclic olefin copolymer); and other special engineering plastics such as PMMA (polymethyl methacrylate).

[0093] like Figures 5 to 8As shown, the extrusion device 2 includes a first extruder 21 and a second extruder 22 that can move closer or further apart and allow ultraviolet light to pass through. During virus inactivation, the container 1 containing the biological product to be inactivated is located between the first extruder 21 and the second extruder 22. When the first extruder 21 and the second extruder 22 approach each other, the container 1 deforms under the pressure applied by the first extruder 21 and the second extruder 22. The first extruder 21 and the second extruder 22 are positioned correspondingly, and the surfaces of the first extruder 21 and the second extruder 22 that contact the container 1 are planar, and the surface area is greater than or equal to the maximum area of ​​the container 1 after deformation. This effectively and uniformly flattens the container 1 into a flat shape, ensuring consistent thickness throughout. Furthermore, when the virus inactivation system is working, both the first extruder 21 and the second extruder 22 are horizontally positioned. The container 1 is also horizontally positioned when placed between the first extruder 21 and the second extruder 22 and being extruded. This allows the biological product inside the container 1 to be evenly spread out under the action of gravity, ensuring consistent thickness throughout. Figure 8 The image shows the state of container 1 after it has been flattened by the first extruder 21 and the second extruder 22. The thickness of container 1 is uniform throughout.

[0094] The shape and size of the surfaces of the first extruder 21 and the second extruder 22 that contact the container 1 are determined according to the capacity of the container 1 and the set compression thickness. Their shape and size ensure that after the container 1 is placed in the center of the surface and compressed to the set compression thickness, no film or contents exceed the boundaries of the surfaces of the first extruder 21 and the second extruder 22. In some embodiments, the first extruder 21 and the second extruder 22 are flat, with their upper and lower surfaces being square, and side lengths ranging from 25 cm to 150 cm. Taking a 200 ml container as an example, when a square flat bag is compressed to a thickness of 0.02 cm, the container 1 occupies a planar area of ​​approximately 1 square meter and a side length of approximately 1 meter. Therefore, the planes of the first extruder 21 and the second extruder 22 are square with a side length greater than or equal to 1 meter.

[0095] By pre-setting the limit values ​​of the stroke of the first extruder 21 and the second extruder 22 moving towards each other, the distance between the first extruder 21 and the second extruder 22 when they approach each other to their closest point is controlled to be 0.02 cm to 2 cm, and further to 0.02 cm to 0.5 cm. When the distance between the first extruder 21 and the second extruder 22 is controlled to be 0.02 cm, the distance of the container 1 after compression is approximately 0.02 cm; when the distance between the first extruder 21 and the second extruder 22 is controlled to be 0.5 cm, the distance of the container 1 after compression is approximately 0.5 cm. That is, the thickness of the container 1 after compression can be controlled by adjusting the pre-set limit values ​​of the stroke of the first extruder 21 and the second extruder 22 moving towards each other.

[0096] In some embodiments, the first extruder 21 and the second extruder 22 are made of quartz, meaning they are both solid quartz plates. This facilitates ultraviolet light transmission and is easy to manufacture. The thickness of the first extruder 21 and the second extruder 22 is 0.1 cm to 0.5 cm. The appropriate thickness is selected based on the area and weight to ensure that the quartz plate is strong enough to withstand the pressure at the contact point / surface without breaking during mechanical lifting or pressing.

[0097] This invention uses a quartz plate to extrude a container 1 into a uniform thin sheet. Compared to making a container 1 from quartz material for holding biological products, it has the following advantages: First, reusable quartz containers, if not cleaned promptly and thoroughly, are prone to denaturation and adhesion of large protein molecules to the container wall, resulting in high cleaning and disinfection costs. Second, non-disposable instruments are not suitable for single-person, single-blood collection scenarios, potentially leading to cross-reactions or allergies between blood samples, as well as cross-contamination of viral factors. Third, high-throughput quartz container methods involving cleaning and drying steps are time-consuming and involve numerous steps, resulting in a long overall processing time. The solution of this invention provides immediate sterilization, retrieval, and use, offering higher efficiency and applicability to a wider range of scenarios.

[0098] The extrusion device 2 further includes a transmission assembly connected to the first extruder 21 and / or the second extruder 22 and capable of driving the first extruder 21 and the second extruder 22 to move closer or further apart, and a power source 23 connected to the transmission assembly and capable of driving the transmission assembly to move. The power source 23 can be a motor, and the transmission assembly can be a device capable of converting the rotation of the motor shaft into linear motion to drive the relative movement of the first extruder 21 and the second extruder 22. Alternatively, the power source 23 can be a cylinder, and the transmission assembly can be a device connected to the piston of the cylinder to drive the relative movement of the first extruder 21 and the second extruder 22.

[0099] In some implementations, the first extrusion member 21 is fixedly connected to the chamber 41, and the second extrusion member 22 is connected to the transmission assembly and can move in the vertical direction under the drive of the transmission assembly. In use, the container 1 is placed on the first extrusion member 21, and the first extrusion member 21 remains fixed, which can avoid the risk of the container 1 not being evenly extruded due to shaking and displacement.

[0100] In some implementations, such as Figures 1 to 7 As shown, the transmission components and power source 23 are symmetrically arranged on the left and right sides of the second extruder 22, which is beneficial to the stability of the up-and-down movement of the second extruder 22. The structure of one set of transmission components and power source 23 is described below. The two sets of structures are the same and can be arranged symmetrically.

[0101] The transmission assembly includes a screw 24, one end of which is connected to and driven to rotate by a power source 23; a nut 25 mounted on and cooperating with the screw 24; and a connecting rod 26 fixedly connected to the nut 25. The power source 23 is a motor. One end of the screw 24 is fixedly connected to the motor shaft, and the rotation of the motor shaft drives the screw 24 to rotate around its own axis. The other end of the screw 24 is rotatably mounted on the housing 41 via a bearing. The screw 24 is arranged vertically. The connecting rod 26 is fixedly arranged relative to the second extruder 22. When the screw 24 rotates around its own axis, the nut 25 moves upward or downward relative to the screw 24, causing the connecting rod 26 to move upward or downward, which in turn causes the second extruder 22 to move upward or downward. To further ensure that the second extruder 22 remains horizontal during vertical movement, there are two or more connecting rods 26. These two or more connecting rods 26 are evenly distributed along the width direction of the second extruder 22, i.e., the front-to-back direction, thereby ensuring the uniformity of the force on the second extruder 22 in the front-to-back direction.

[0102] In some implementations, such as Figures 1 to 7 As shown, the power source 23, screw 24, and nut 25 are located outside the housing 41. Specifically, the power source 23 is mounted on the outer wall of the housing 41, the screw 24 is mounted on the outer wall of the housing 41, and the connecting rod 26 passes through the side wall of the housing 41 to connect to the nut 25 and the second pressing member 22, respectively. A first groove 43 extending vertically is provided on the outer wall of the housing 41. The connecting rod 26 is inserted into the first groove 43. When the power source 23 drives the screw 24 to rotate, causing the connecting rod 26 to move vertically, the first groove 43 provides clearance for the movement of the connecting rod 26 while also serving a guiding function. The number of first grooves 43 corresponds to the number of connecting rods 26, and their positions are corresponding.

[0103] In some other embodiments (not shown), the power source 23, screw 24, and nut 25 are located inside the chamber 41. Specifically, the power source 23 is installed on the inner wall of the chamber 41 or placed on the bottom surface of the chamber 41, and the screw 24 is also installed on the inner wall of the chamber 41. In this configuration, when the door 42 is closed, the interior of the isolation chamber 4 is sealed. By installing a vacuum device on the isolation chamber 4, a vacuum can be created inside the isolation chamber 4, resulting in a negative pressure state. This reduces oxygen levels inside the isolation chamber 4, prevents the generation of trace ozone, improves the oxidation effect of air on the biological products, and further enhances the retention rate of biomolecules in the biological products.

[0104] In some implementations, such as Figures 1 to 7 As shown, the extrusion device 2 also includes a first mounting bracket 5 fixedly connected to the first extruder 21 and the chamber 41 respectively, a second mounting bracket 6 fixedly connected to the second extruder 22, a first support member 7 whose lower end is rotatably connected to the first mounting bracket 5 and whose upper end is rotatably and slidably connected to the second mounting bracket 6, and a second support member 8 whose lower end is rotatably and slidably connected to the first mounting bracket 5 and whose upper end is rotatably connected to the second mounting bracket 6; the middle position of the first support member 7 and the middle position of the second support member 8 are rotatably connected. The cross-bracing structure formed by the first support member 7 and the second support member 8 can further improve the stability of the movement of the second extruder 22.

[0105] The rotatable connection between the support member and the mounting frame can be achieved through a rotating shaft. The rotatable and sliding connection between the support member and the mounting frame can be achieved through the following structure: The first mounting frame 5 and the second mounting frame 6 are respectively provided with second sliding grooves 9 extending in the front-rear direction. The first support member 7 and the second support member 8 are respectively provided with protrusions 10, which are correspondingly inserted into the corresponding second sliding grooves 9 and can slide within them. The length of the second sliding groove 9 is greater than or equal to the travel stroke of the second pressing member 22; that is, the length of the second sliding groove 9 is set to ensure that the second pressing member 22 can be pressed down to the set distance between the first pressing member 21 and the second pressing member 22.

[0106] In some implementations, the length of the second groove 9 is consistent with the travel of the second extruder 22. That is, when the first extruder 21 and the second extruder 22 are close to each other, the protrusions 10 on the first support 7 and the second support 8 are located on the outermost side of the second groove 9. The outermost groove wall of the second groove 9 can prevent the first support 7 and the second support 8 from continuing to slide outward, thereby preventing the second extruder 22 from continuing to move downward and reducing the risk of the second extruder 22 pressing down too much and compressing the container 1.

[0107] Similar to the symmetrically arranged transmission components, the first support member 7 and the second support member 8 are also two sets symmetrically arranged on the left and right sides of the second extruder 22.

[0108] The ultraviolet lamp assembly 3 includes multiple ultraviolet lamps 31 emitting UVC bands, located below the first extruder 21 and above the second extruder 22. The lower ultraviolet lamps 31 are fixedly mounted on the bottom surface of the first mounting frame 5 or the cabin 41, or movable vertically, while the upper ultraviolet lamps 31 are fixedly mounted on the second mounting frame 6. The distance between the lower ultraviolet lamp 31 and the first extruder 21 is 5 cm to 20 cm, and the distance between the upper ultraviolet lamp 31 and the second extruder 22 is also 5 cm to 20 cm. If the ultraviolet lamps 31 are fixedly mounted, the distance between them and the extruders is set according to the capacity of the container 1, the number of ultraviolet lamps 31, and their intensity. If the ultraviolet lamps 31 are movable, the distance between them and the extruders can be adjusted according to the virus inactivation status. For movable ultraviolet lamps 31, any existing driving structure can be used.

[0109] The projections of the upper and lower ultraviolet lamps 31 on the horizontal plane are staggered, and the staggered distance between adjacent ultraviolet lamps 31 is equal, to ensure that the biological product in container 1 receives more uniform ultraviolet radiation. The ultraviolet lamps 31 can be lamp tubes or lamp beads. The upper ultraviolet lamps 31 are on the same horizontal plane, and the lower ultraviolet lamps 31 are also on the same horizontal plane. In some embodiments, such as... Figures 5 to 8 As shown, the ultraviolet lamp 31 is a lamp tube, with 3 ultraviolet lamps 31 located at the top and 4 ultraviolet lamps 31 located at the bottom.

[0110] The average UV intensity on one side of container 1 is 2000-5000 μW / cm. 2 UVC energy is 5-200 mJ / cm 2 The outer surface of the ultraviolet lamp 31 is covered with a filter film capable of filtering out ultraviolet rays with wavelengths other than 254±5nm. This filter film is an explosion-proof filter film to improve the safety of the ultraviolet lamp. In some embodiments, the ultraviolet lamp 31 uses a wavelength of 253.7nm. By using an ultraviolet lamp 31 with a specific wavelength and further by setting a filter film, the generation of trace ozone can be prevented, the oxidation effect of air on biological products can be improved, and the activity retention rate of biomolecules in biological products can be further improved.

[0111] The virus inactivation device also includes a first light-blocking curtain 11, which is positioned between the lower ultraviolet lamp 31 and the first extruder 21 and can be opened and rolled up, and a second light-blocking curtain 12, which is positioned between the upper ultraviolet lamp 31 and the second extruder 22 and can be opened and rolled up. When the first light-blocking curtain 11 and the second light-blocking curtain 12 are in the open state, they prevent ultraviolet light from irradiating the container 1; when they are in the rolled-up state, the container 1 is exposed to ultraviolet radiation. When the virus inactivation device is activated, the first light-blocking curtain 11 and the second light-blocking curtain 12 are in the open state. At this time, the ultraviolet lamp 31 is turned on and the light intensity is balanced. Then, the first light-blocking curtain 11 and the second light-blocking curtain 12 are rolled up to ensure that the container 1 receives balanced UVC irradiation, thereby improving the virus inactivation effect and efficiency.

[0112] The virus inactivation device also includes a drive unit connected to the first blackout curtain 11 and the second blackout curtain 12, respectively, and capable of automatically retracting the first and second blackout curtains 11 and 12. The first blackout curtain 11 and the drive unit for retracting the first blackout curtain 11 are mounted on the first mounting frame 5, and the second blackout curtain 12 and the drive unit for retracting the second blackout curtain 12 are mounted on the second mounting frame 6. The drive unit may only automatically retract the first and second blackout curtains 11 and 12, but cannot automatically open them; opening the blackout curtains requires manual operation. Alternatively, the drive unit may automatically retract and open both the first and second blackout curtains 11 and 12. The structure of the drive unit can, for example, adopt the drive structure of a sunroom shading curtain. Preferably, the drive unit is capable of automatically retracting and opening both the first and second blackout curtains 11 and 12.

[0113] The virus inactivation system also includes a temperature probe, a UV irradiation probe, an induction timer, and a workbench 13 installed in the cabin 41 to control the operation of the virus inactivation system and to control the automatic operation of each component of the virus inactivation system. The central control system of the workbench 13 can use existing technology, as long as it can automatically control the movement of the power source 23, the opening and closing of the ultraviolet lamp 31, and the rolling up of the blackout curtain.

[0114] In some implementations, the biological product is a blood product, such as plasma or cryoprecipitate.

[0115] The virus inactivation system described above is mainly suitable for virus inactivation of single-unit plasma.

[0116] Taking plasma as an example, the method for virus inactivation using this virus inactivation system is as follows: After blood collection, the plasma formed through steps such as anticoagulation and red blood cell separation is first subjected to virus inactivation in this virus inactivation system before freezing.

[0117] After a single plasma sample is placed in container 1, it is placed in the center of the quartz plate of the first extruder 21. The door 42 is closed, and the following operations are performed sequentially on the workbench 13: the isolation chamber 4 is selectively evacuated to reduce oxygen; the first and second light-shielding curtains 11 and 12 are opened to shield the plasma; the ultraviolet lamp 31 is turned on and the light intensity is balanced; the power source 23 is controlled to lower the second mounting bracket 6, the second extruder 22 quartz plate, the ultraviolet lamp 31, and the second light-shielding curtain 12 as a whole until the second extruder 22 flattens the container 1 to the same thickness. At the same time, the first and second light-shielding curtains 11 and 12 are rolled up, and the ultraviolet lamp 31 irradiates the central container 1. After the irradiation reaches the rated time and inactivation is completed, the ultraviolet lamp 31 is turned off, the first and second light-shielding curtains 11 and 12 open automatically, the system issues a prompt, the container 1 is removed, and the plasma is transferred to a plasma collection / freezing bag for further testing, freezing, transportation, and other operations.

[0118] In the second embodiment, the container 1 has an opening including an inlet on one side and an outlet on the other side. The virus inactivation system also includes an inlet pipe integrated with the inlet of the container 1, an outlet pipe integrated with the outlet of the container 1, a first storage tank 53 connected to the inlet pipe for storing the biological product before inactivation, a second storage tank 56 connected to the outlet pipe for storing the biological product after inactivation, and peristaltic pumps 57 respectively installed on the inlet and outlet pipes. The container 1, the inlet pipe, and the outlet pipe are all disposable consumables. The first storage tank 53 and the second storage tank 56 can be disposable consumables or can be reused after cleaning and sterilization. The side wall of the chamber 41 has through holes for the inlet and outlet pipes to pass through. If the isolation chamber 4 is a sealed structure when the door 42 is closed, a sealing gasket is provided at the position of the through hole to ensure the airtightness of the isolation chamber 4.

[0119] The virus inactivation system in this embodiment can continuously inactivate viruses in large quantities of biological products. After the virus inactivation of one batch of biological products is completed, the disposable consumables are replaced as a whole for the next batch of virus inactivation. In this embodiment, in order to better compress container 1 and prevent the gas inside container 1 from affecting the entry of biological products, container 1 is also provided with an air outlet. This air outlet is equipped with a one-way valve to allow only the gas inside container 1 to be discharged in one direction. The other structures in this embodiment, such as the compression device 2, the ultraviolet lamp assembly 3, and the light-shielding curtain, are the same as those in the first embodiment, and will not be described again here.

[0120] In the third embodiment, the isolation chamber 4 includes multiple separate sub-chambers 44, each sub-chamber 44 having a corresponding door, and each sub-chamber 44 having a corresponding container 1, a squeezing device 2, and an ultraviolet lamp assembly 3. The inlet pipe includes a main inlet pipe 51 connected to the first storage tank 53, and multiple inlet branch pipes 52 integrally formed with the inlet of each container 1, with the multiple inlet branch pipes 52 connected to the main inlet pipe 51. The outlet pipe includes a main outlet pipe 54 connected to the second storage tank 56, and multiple outlet branch pipes 55 integrally formed with the outlet of each container 1, with the multiple outlet branch pipes 55 connected to the main outlet pipe 54. A peristaltic pump 57 is respectively installed on the main inlet pipe 51 and the main outlet pipe 54. This embodiment of the virus inactivation system can improve the efficiency of continuous virus inactivation for large quantities of biological products. The other structures of the virus inactivation system in this embodiment are the same as in the second embodiment, and will not be described again here.

[0121] In the second and third embodiments, the inlet pipe and outlet pipe connected to container 1 are integrally formed with container 1, which can avoid blind spots in light. The connection method of the main inlet pipe 51 and the branch inlet pipe 52, and the connection method of the main outlet pipe 54 and the branch outlet pipe 55 can refer to the connection method of blood bags, infusion tubes, etc.

[0122] The number of sub-compartments 44 can be two, three, four or more, and multiple sub-compartments 44 can be stacked in the vertical direction or in the horizontal direction. Figures 9 to 16 A specific embodiment of the third implementation is shown, wherein there are three sub-compartments 44, stacked vertically. A screw 24 extends vertically across the three sub-compartments 44, and three nuts 25 are respectively provided on the screw 24. Each nut 25 corresponds to a set of connecting rods 26 to drive the second extrusion member 22 in one sub-compartment 44. The screw 24 drives the second extrusion members 22 in the three sub-compartments 44 to move synchronously through a power source 23. For the scheme of synchronously driving multiple second extrusion members 22 through a single screw 24, a screw with sufficient strength and precision is sufficient.

[0123] Taking plasma as an example, the method for inactivating viruses in large quantities of plasma using this virus inactivation system is as follows: After blood collection, the plasma formed through steps such as anticoagulation and red blood cell separation is first subjected to virus inactivation in the virus inactivation system before freezing.

[0124] Install disposable consumables such as container 1, inlet pipe, outlet pipe, first storage tank 53, and second storage tank 56. Close the hatch 42 and perform the following operations sequentially on the workbench 13: selectively evacuate the isolation chamber 4 to reduce oxygen; open the first and second light-blocking curtains 11 and 12 to shield the chamber; turn on the ultraviolet lamp 31 and balance the light intensity; control the power source 23 to make the second mounting bracket 6, the second extrusion piece 22 quartz plate, the ultraviolet lamp 31, and the second light-blocking curtain 12 descend as a whole until the distance between the first and second extrusion pieces 21 and 22 reaches the specified thickness, at which point the descent stops. At this time, the empty container 1 is clamped in the first... Between the extrusion component 21 and the second extrusion component 22, the first light-blocking curtain 11 and the second light-blocking curtain 12 are rolled up simultaneously. The ultraviolet lamp 31 then irradiates the central container 1. The plasma is pumped into the container 1 through the inlet pipe by the peristaltic pump 57. The plasma can be continuously added and removed or pumped in segments. After a certain volume of plasma is pumped in, the peristaltic pump 57 automatically stops to inactivate the virus. After the irradiation reaches the rated time and inactivation is completed, the plasma is pumped into the second storage tank 56 through the outlet pipe by the peristaltic pump 57. The ultraviolet lamp 31 is turned off, and the first light-blocking curtain 11 and the second light-blocking curtain 12 automatically open. The system issues a prompt, and the collected plasma is then subjected to further testing, freezing, transportation, and other operations.

[0125] Under this large-scale virus inactivation protocol, the processing volume of one batch of plasma is 100-500L. At this processing volume, insoluble matter will not adhere to the inner wall of container 1, thus affecting the virus inactivation effect.

[0126] The virus inactivation system of the present invention can be used for pathogen inactivation treatment of single-dose plasma after blood collection at blood banks, rapid and safe treatment of plasma for emergency transfusion, and pathogen inactivation treatment of large-scale plasma production.

[0127] In this invention, the quartz material does not directly contact the biological product. Instead, the container 1 is thinned by using a quartz plate. This solves the problems of excessive thickness, uneven light penetration, repeated irradiation areas and shadow areas, poor uniformity, low light transmittance, and long processing time when the bag-shaped container 1 is laid flat under natural conditions. It also solves the problems of welding strength and cleaning at the joints of the quartz tube processing.

[0128] By pressing container 1 to a set thickness using a quartz plate, the optical path length for light to penetrate the plasma is compressed using physical methods, and the optical path non-uniformity is reduced to below 5%, which greatly improves UVC penetration and shortens the inactivation time by more than 90% (the irradiation time for traditional plasma inactivation methods is 40-90 minutes, while this invention only requires 1-2 minutes). This not only helps to preserve the activity of biological macromolecules in plasma, but the extremely short irradiation time is also suitable for ensuring the safety of blood products in emergency situations such as emergency blood transfusions.

[0129] This invention utilizes UVC for purely physical inactivation of blood products such as plasma, eliminating the need for additives and thus leaving no chemical residues. The processing time can be reduced to 1-2 minutes per unit of plasma, significantly lowering processing costs, while maintaining a protein retention rate of over 95%. The virus inactivation capability of this invention is >6 log for non-lipid-enveloped viruses and 4-5 log for lipid-enveloped viruses, showing particularly good inactivation effects against non-lipid-enveloped viruses that are difficult to inactivate using other methods. It can greatly supplement or replace traditional blood product virus inactivation protocols, and is especially suitable for time-sensitive scenarios such as large-scale epidemics or wartime trauma emergency care.

[0130] The above embodiments are only for illustrating the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be construed as limiting the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A virus inactivation system, characterized in that: It includes: Container (1), the container (1) is used to hold biological products to be inactivated viruses, the container (1) has an opening that can be opened and closed, the container (1) allows ultraviolet light to pass through, can deform under pressure and is biocompatible; the container (1) is a disposable container; The extrusion device (2) includes a first extruder (21) and a second extruder (22) that can move closer or further apart and allow ultraviolet light to pass through. During virus inactivation in the virus inactivation system, the container (1) is horizontally placed between the first extruder (21) and the second extruder (22). When the first extruder (21) and the second extruder (22) move closer together, the container (1) deforms under the pressure exerted by the first extruder (21) and the second extruder (22). The thickness of the container (1) after being extruded by the first extruder (21) and the second extruder (22) is... The first extruder (21) and the second extruder (22) have a contact surface with the container (1) of 0.02 cm to 2 cm. The surfaces of the first extruder (21) and the second extruder (22) are flat and the area of ​​the surface is greater than or equal to the maximum area of ​​the container (1) after deformation. The extrusion device (2) also includes a transmission component connected to the first extruder (21) and / or the second extruder (22) and capable of driving the first extruder (21) and the second extruder (22) to move closer or further away from each other, and a power source (23) connected to the transmission component and capable of driving the transmission component to move. The first extruder (21) is located below the second extruder (22). The ultraviolet lamp assembly (3) includes a plurality of ultraviolet lamps (31) emitting UVC bands. The plurality of ultraviolet lamps (31) are respectively located on the side of the first extruder (21) and the second extruder (22) away from the container (1). The ultraviolet lamp (31) located below is 5 cm to 20 cm away from the first extruder (21), and the ultraviolet lamp (31) located above is 5 cm to 20 cm away from the second extruder (22). An isolation chamber (4) includes a chamber body (41) and a door (42) that can be opened and closed. The container (1), the first extruder (21), the second extruder (22) and the ultraviolet lamp assembly (3) are installed inside the chamber body (41). The first extrusion member (21) is fixedly connected to the cabin body (41), and the second extrusion member (22) is connected to the transmission assembly and can move along the vertical direction under the drive of the transmission assembly; The transmission assembly includes a screw (24) connected at one end to the power source (23) and driven to rotate by the power source (23), a nut (25) mounted on the screw (24) and cooperating with the screw (24), and a connecting rod (26) fixedly connected to the nut (25). The connecting rod (26) is fixedly arranged relative to the second extruder (22), and the other end of the screw (24) is rotatably mounted on the cabin (41). The power source (23), the screw (24) and the nut (25) are located inside or outside the housing (41). When the power source (23), the screw (24) and the nut (25) are located outside the housing (41), a first groove (43) extending in the vertical direction is provided on the outer wall of the housing (41). The connecting rod (26) is inserted in the first groove (43). The number of connecting rods (26) and the first groove (43) is two or more and they are evenly distributed along the width direction of the second extruder (22). The transmission assembly and the power source (23) are two sets symmetrically arranged on the left and right sides of the second extruder (22); the power source (23) is a motor.

2. The virus inactivation system according to claim 1, characterized in that: The thickness of the container (1) after being compressed by the first extruder (21) and the second extruder (22) is 0.02 cm to 0.5 cm.

3. The virus inactivation system according to claim 1, characterized in that: The container (1) has a capacity of 100 ml to 400 ml.

4. The virus inactivation system according to claim 1, characterized in that: The container (1) is bag-shaped; and / or, the container (1) is a square flat bag or a round flat bag; and / or, the single-layer wall thickness of the container (1) is 0.20 mm to 0.75 mm; and / or, the UVC transmittance of the container (1) is above 80%; and / or, the material of the container (1) is fluoropolymer, polyolefin, or other special engineering plastic.

5. The virus inactivation system according to claim 1, characterized in that: When the first extruder (21) and the second extruder (22) are close to each other, the distance between the first extruder (21) and the second extruder (22) is 0.02 cm to 2 cm.

6. The virus inactivation system according to claim 5, characterized in that: When the first extruder (21) and the second extruder (22) are close to each other, the distance between the first extruder (21) and the second extruder (22) is 0.02 cm to 0.5 cm.

7. The virus inactivation system according to claim 1, characterized in that: The first extrusion piece (21) and the second extrusion piece (22) are made of quartz; and / or, the first extrusion piece (21) and the second extrusion piece (22) are flat; and / or, the thickness of the first extrusion piece (21) and the second extrusion piece (22) is 0.1 cm to 0.5 cm; and / or, the upper and lower surfaces of the first extrusion piece (21) and the second extrusion piece (22) are square.

8. The virus inactivation system according to claim 1, characterized in that: The extrusion device (2) further includes a first mounting bracket (5) fixedly connected to the first extruder (21) and the cabin (41) respectively, a second mounting bracket (6) fixedly connected to the second extruder (22), a first support member (7) whose lower end is rotatably connected to the first mounting bracket (5) and whose upper end is rotatably and slidably connected to the second mounting bracket (6), and a second support member (8) whose lower end is rotatably and slidably connected to the first mounting bracket (5) and whose upper end is rotatably connected to the second mounting bracket (6); the first support member (7) and the second support member (8) are rotatably connected.

9. The virus inactivation system according to claim 8, characterized in that: The first support member (7) and the second support member (8) are two sets symmetrically arranged on the left and right sides of the second extruder (22).

10. The virus inactivation system according to claim 8, characterized in that: The first mounting bracket (5) and the second mounting bracket (6) are respectively provided with second sliding grooves (9) extending in the front-back direction. The first extrusion member (21) and the second extrusion member (22) are respectively provided with protrusions (10) inserted into the second sliding grooves (9) and able to slide in the second sliding grooves (9). When the first extrusion member (21) and the second extrusion member (22) are close to each other to the closest state, the protrusions (10) on the first support member (7) and the second support member (8) are respectively located on the outermost side of the second sliding grooves (9).

11. The virus inactivation system according to claim 8, characterized in that: The lower ultraviolet lamp (31) is fixed or movable in the vertical direction and is mounted on the bottom surface of the first mounting frame (5) or the cabin (41), while the upper ultraviolet lamp (31) is fixed or movable in the vertical direction and is mounted on the second mounting frame (6).

12. The virus inactivation system according to claim 1, characterized in that: The projections of the upper UV lamp (31) and the lower UV lamp (31) on the horizontal plane are staggered, and the staggered distance between two adjacent UV lamps (31) is equal; and / or, the average UV intensity of one side surface of the container (1) is 2000-5000 μW / cm. 2 ; and / or, the outer surface of the ultraviolet lamp (31) is formed with an explosion-proof filter film capable of filtering out ultraviolet rays with wavelengths other than 254±5nm.

13. The virus inactivation system according to claim 1, characterized in that: The virus inactivation system further includes a first light-blocking curtain (11) disposed between the lower ultraviolet lamp (31) and the first extruder (21) and capable of being opened and rolled up, and a second light-blocking curtain (12) disposed between the upper ultraviolet lamp (31) and the second extruder (22) and capable of being opened and rolled up; when the first light-blocking curtain (11) and the second light-blocking curtain (12) are in the open state, the first light-blocking curtain (11) and the second light-blocking curtain (12) prevent ultraviolet rays from irradiating the container (1); when the first light-blocking curtain (11) and the second light-blocking curtain (12) are in the rolled-up state, the container (1) is exposed to ultraviolet radiation.

14. The virus inactivation system according to claim 13, characterized in that: The virus inactivation device also includes a drive device that is connected to the first light-blocking curtain (11) and the second light-blocking curtain (12) respectively and is capable of automatically retracting the first light-blocking curtain (11) and the second light-blocking curtain (12).

15. The virus inactivation system according to claim 1, characterized in that: When the door (42) is closed, the isolation chamber (4) is in a sealed state. The virus inactivation system also includes a vacuuming device connected to the chamber (41) and capable of evacuating the chamber (41); and / or, the virus inactivation system also includes a temperature probe, a UV irradiation probe, an induction timer, and a workbench (13) for controlling the operation of the virus inactivation system installed in the chamber (41).

16. The virus inactivation system according to any one of claims 1 to 15, characterized in that: The container (1) has an opening including an inlet on one side and an outlet on the other side. The virus inactivation system also includes an inlet pipe integrally formed with the inlet of the container (1), an outlet pipe integrally formed with the outlet of the container (1), a first storage tank (53) connected to the inlet pipe and used to store biological products before inactivation, a second storage tank (56) connected to the outlet pipe and used to store biological products after inactivation, and peristaltic pumps (57) respectively set on the inlet pipe and the outlet pipe. The container (1), the inlet pipe and the outlet pipe are all disposable consumables.

17. The virus inactivation system according to claim 16, characterized in that: The isolation chamber (4) includes multiple separate sub-chambers (44), each sub-chamber (44) is provided with a door (42), and each sub-chamber (44) is provided with the container (1), the squeezing device (2) and the ultraviolet lamp assembly (3); the liquid inlet pipe includes a main liquid inlet pipe (51) connected to the first storage tank (53) and multiple liquid inlet branch pipes (52) integrally provided with the inlet of each container (1), and the multiple liquid inlet branch pipes (52) are connected to the main liquid inlet pipe (51); the liquid outlet pipe includes a main liquid outlet pipe (54) connected to the second storage tank (56) and multiple liquid outlet branch pipes (55) integrally provided with the outlet of each container (1), and the multiple liquid outlet branch pipes (55) are connected to the main liquid outlet pipe (54); the peristaltic pump (57) is respectively provided on the main liquid inlet pipe (51) and the main liquid outlet pipe (54).

18. The virus inactivation system according to claim 1, characterized in that: The biological product is a liquid biological product; further, the liquid biological product is a vaccine preparation, toxin preparation, toxoid preparation, immune serum, blood product, immunoglobulin preparation, antigen preparation, allergen preparation, cytokine preparation, hormone preparation, enzyme product, fermentation broth, monoclonal antibody preparation, or in vitro immunodiagnostic product; even further, the biological product is a blood product; and / or, The viruses mentioned include one or more of the following families: Reoviridae, Rhabdoviridae, Orthomyxoviridae, Filoviridae, Coronaviridae, Bunyaviridae, Bonaviviridae, Flaviviridae, Paramyxoviridae, Clonorviridae, Arenaviridae, Microribonucleoviridae, Caliciviridae, Retroviridae, Poxviridae, Herpesviridae, Iridoviridae, Papillomaviridae, and Parvoviridae.

19. A method for inactivating a virus, characterized in that: The virus inactivation system according to any one of claims 1 to 18 is used to inactivate the biological products containing the virus to be inactivated. After the virus inactivation of one batch of biological products is completed, a new container (1) is used to inactivate the next batch of biological products.

Images