Sterilization device
By introducing a sterilization treatment device consisting of a reaction vessel and a filter cartridge into the production of injection-grade povidone K17, and utilizing 0.45μm and 0.22μm microporous filter membranes, the problem of sterilization instability of traditional sterilization treatment devices in complex environments has been solved, achieving efficient endotoxin removal and product quality assurance.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- JIAOZUO ZHONGWEI CHEM
- Filing Date
- 2025-08-25
- Publication Date
- 2026-07-24
Smart Images
Figure CN224541430U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of biomedical technology, and in particular to a sterilization treatment device. Background Technology
[0002] Injectable grade povidone K17 is an important pharmaceutical excipient with wide applications in the pharmaceutical field. It is often used as a solubilizer, stabilizer, and suspending agent in injectable preparations, and its quality is directly related to the safety and efficacy of drugs.
[0003] In the traditional production process of injectable povidone K17, sterilization has always been a key factor affecting product quality. However, traditional processes have significant shortcomings in the stability of sterilization effectiveness. Traditional sterilization methods, such as filtration, often fail to effectively remove endotoxins to within acceptable limits when faced with complex production environments and high endotoxin loads. This not only increases the risk of product non-compliance but also imposes enormous quality control pressure and economic losses on pharmaceutical manufacturers, while simultaneously hindering the further application of injectable povidone K17 in high-end pharmaceutical fields. Utility Model Content
[0004] The purpose of this invention is to address the significant shortcomings of existing traditional processes in terms of the stability of sterilization effects. Traditional sterilization methods, such as filtration, often fail to effectively remove endotoxins to acceptable levels when faced with complex production environments and high endotoxin loads. This not only increases the risk of product non-compliance but also imposes enormous quality control pressure and economic losses on pharmaceutical manufacturers. Furthermore, it restricts the further application of injectable-grade povidone K17 in high-end pharmaceutical fields. Therefore, this proposed sterilization device addresses these shortcomings.
[0005] To achieve the above objectives, the present invention adopts the following technical solution: The sterilization treatment device includes a reaction vessel fixedly installed on the ground, a raw material filter cartridge, and a reaction liquid post-filter cartridge. The outlet of the raw material filter cartridge is connected to the inlet of the reaction vessel through a pipeline and a delivery pump, and the outlet of the reaction vessel is connected to the inlet of the reaction liquid post-filter cartridge through a pipeline and a delivery pump. The inner wall of the raw material filter cartridge is fixedly connected to a placement strip, a filter membrane is installed on the placement strip, and a flow guiding component is provided on the filter membrane to press and stabilize the filter membrane. The filter cartridge after the reaction liquid is provided with the same filter membrane and flow guiding component as the raw material filter cartridge.
[0006] Preferably, the top opening of the raw material filter cylinder is threadedly connected to a cylinder cover with a feeding hopper, and the top opening of the reaction liquid filter cylinder is threadedly connected to a sealing cap.
[0007] Preferably, the top edge of the filter membrane is provided with an installation groove, a sealing gasket is fitted on the installation groove, and a drain outlet is provided on the inner wall of the installation groove.
[0008] Preferably, the flow guiding assembly includes a flow guiding box installed above the filter membrane, a screw is fixedly connected to one side of the top of the flow guiding box, a fixing rod is fixedly connected to the other side of the top of the flow guiding box, a rotating cylinder is threaded onto the screw, a sliding cylinder is sleeved on the fixing rod, and a top plate is fixedly connected to the top of the sliding cylinder.
[0009] Preferably, a pair of screws, fixing rods, and top plates are provided, the top of the rotating cylinder is rotatably connected to the bottom of the top plate, and the screws and fixing rods are symmetrically distributed.
[0010] Preferably, the filter membrane on the raw material filter cartridge is a microporous membrane with a diameter of 0.1 micrometers, the filter membrane on the reaction liquid filter cartridge is a microporous membrane with a diameter of 0.1 micrometers, and the connecting pipe between the reaction vessel, the raw material filter cartridge, and the reaction liquid filter cartridge is a closed sterile pipe.
[0011] Based on the above content and purpose, please help me write a beneficial effect; Compared with the prior art, the beneficial effects of this utility model are as follows: 1. When using this utility model, a 0.45μm sterilization filtration step can be added before the raw and auxiliary materials are fed in, which can significantly reduce the initial load of microorganisms and endotoxins from the very source of production, reduce the sterilization pressure of subsequent process links, and set a 0.22μm sterilization-grade filter at the most critical position before spray drying. This can filter out most of the bacterial corpses and particles that may exist in the polymerization reaction liquid, directly and efficiently reduce the bacterial endotoxin content, and provide a last solid guarantee for the quality of the final product.
[0012] 2. In use, the flow guiding component, through the cooperation of the screw, rotating cylinder, fixed rod, and sliding cylinder, can stably compress the filter membrane, preventing membrane displacement or wrinkling due to pressure changes during filtration, thus ensuring effective utilization of the filtration area and consistent filtration effect. The mounting groove and sealing gasket design at the edge of the filter membrane further enhance the sealing performance of the filter cartridge, preventing leakage of unfiltered materials and ensuring filtration accuracy. The threaded connection structure between the cylinder cover and the filter cartridge facilitates filter membrane replacement and maintenance, reducing the difficulty of equipment operation. Attached Figure Description
[0013] Figure 1 This is a three-dimensional structural diagram of the sterilization treatment device proposed in this utility model; Figure 2 This is a cross-sectional view of the filter cylinder of the sterilization treatment device proposed in this utility model; Figure 3This is a three-dimensional structural diagram of the filter membrane of the sterilization treatment device proposed in this utility model. Figure 4 This is a three-dimensional structural diagram of the flow guiding component of the sterilization treatment device proposed in this utility model.
[0014] In the diagram: 1. Reactor; 2. Raw material filter cylinder; 3. Reaction liquid filter cylinder; 4. Pipeline; 5. Transfer pump; 6. Placement bar; 7. Filter membrane; 8. Flow guide assembly; 9. Cylinder cover; 10. Sealing cover; 11. Mounting groove; 12. Sealing gasket; 13. Drain outlet; 14. Flow guide box; 15. Screw; 16. Fixing rod; 17. Rotating cylinder; 18. Sliding cylinder; 19. Top plate. Detailed Implementation
[0015] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present utility model. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present utility model without creative effort are within the protection scope of the present utility model.
[0016] Reference Figures 1-4 The sterilization treatment device includes a reaction vessel 1 fixedly installed on the ground, a raw material filter cartridge 2, and a reaction liquid post-filter cartridge 3. All components form a complete material processing flow path through pipes 4 and a delivery pump 5. The reaction vessel 1 is a prior art device used in this field, specifically a polymerization reaction vessel. The polymerization reaction vessel is equipped with a pH sensor, an oxygen content sensor, a temperature controller, a stirrer, and a nitrogen inlet pipe. The nitrogen inlet pipe is connected to the bottom of the polymerization reaction vessel for introducing high-purity nitrogen gas from the bottom of the reaction liquid. An exhaust valve is located at the top of the polymerization reaction vessel, which will not be described in detail here.
[0017] The outlet of the raw material filter cartridge 2 is connected to the inlet of the reactor 1 via a pipe 4 and a transfer pump 5. The outlet of the reactor 1 is connected to the inlet of the reaction liquid filter cartridge 3 via a pipe 4 and a transfer pump 5, thus realizing a continuous processing process from raw material filtration to reaction treatment and then to subsequent filtration. The inner wall of the raw material filter cartridge 2 is fixedly connected with a placement strip 6, which is used to support the filter membrane 7 and provide a stable installation base for the filter membrane 7. The filter membrane 7 is provided with a flow guiding component 8 that can press and stabilize it. The filter cartridge 3 after the reaction liquid is provided with the same filter membrane 7 and flow guiding component 8 as the raw material filter cartridge 2, ensuring the consistency and reliability of the two filtration structures. To facilitate material addition and equipment maintenance, the top opening of the raw material filter cylinder 2 is threadedly connected to a cylinder cover 9 with a feeding hopper. The feeding hopper allows for convenient addition of raw materials, while the threaded connection facilitates the opening and closing of the cylinder cover 9, making it convenient to clean the inside of the filter cylinder or replace parts. The top opening of the reaction liquid filter cylinder 3 is threadedly connected to a sealing cap 10. The tight connection of the sealing cap 10 ensures the airtightness of the filtration process after the reaction liquid and prevents external contamination. The top edge of the filter membrane 7 is provided with an installation groove 11, and a sealing gasket 12 is fitted on the installation groove 11. The sealing gasket 12 can effectively enhance the sealing between the filter membrane 7 and the inner wall of the filter cartridge, prevent unfiltered materials from leaking out from the gaps, and ensure filtration accuracy. The inner wall of the installation groove 11 is provided with a drain outlet 13, which can discharge the accumulated liquid generated during the filtration process in a timely manner to prevent the accumulated liquid from affecting the filtration efficiency. The flow guiding assembly 8 includes a flow guiding box 14 installed above the filter membrane 7. The flow guiding box 14 guides the material, ensuring its uniform distribution on the surface of the filter membrane 7 and improving the filtration effect. A screw 15 is fixedly connected to one side of the top of the flow guiding box 14, and a fixing rod 16 is fixedly connected to the other side. A rotating cylinder 17 is threaded onto the screw 15, and a sliding cylinder 18 is sleeved on the fixing rod 16. A top plate 19 is fixedly connected to the top of the sliding cylinder 18. By rotating the rotating cylinder 17, the screw 15 can be moved up and down, thereby pressing or releasing the filter membrane 7 with the flow guiding box 14. The cooperation between the fixing rod 16 and the sliding cylinder 18 ensures the stability of the flow guiding box 14 during its up and down movement, preventing it from shifting. Each of the screw 15, the fixing rod 16 and the top plate 19 is provided with a pair. The top of the rotating cylinder 17 is rotatably connected to the bottom of the top plate 19. The screw 15 and the fixing rod 16 are symmetrically distributed. This symmetrical structure design further improves the uniformity of the flow guiding assembly 8 pressing the filter membrane 7, ensuring that the filter membrane 7 is under balanced force during operation and avoiding damage due to excessive local force.
[0018] In this embodiment, the filter membrane 7 on the raw material filter cartridge 2 is a 0.45-micron microporous membrane, which can perform preliminary filtration of the raw materials to remove larger particulate impurities and some microorganisms. The filter membrane 7 on the reaction liquid post-filter cartridge 3 is a 0.22-micron microporous membrane, which can perform fine filtration of the reacted materials, effectively removing endotoxins and other minute harmful substances, ensuring the quality of the final product. Meanwhile, the connecting pipe 4 between the reaction vessel 1, the raw material filter cartridge 2, and the reaction liquid post-filter cartridge 3 is a closed sterile pipe, preventing the materials from contacting the external environment throughout the process, preventing secondary contamination, and meeting the strict sterility requirements of pharmaceutical production.
[0019] Working principle: First, the operator opens the cover with the feeding hopper on top of the raw material filter cartridge, adds the material to be processed, and pumps it into the reactor using a transfer pump. During the transfer process, the raw materials undergo preliminary filtration through a 0.45-micron filter membrane, removing larger particles and some microorganisms. After entering the reactor, the polymerization reaction takes place under controlled pH, oxygen content, and temperature conditions. High-purity nitrogen is introduced from the bottom for protection, and a top exhaust valve regulates gas emissions to ensure the reaction proceeds in a safe and sealed environment.
[0020] After the reaction is complete, the reaction solution is pumped into the post-reaction filter cartridge by a transfer pump, where it undergoes fine filtration through a 0.22-micron filter membrane to effectively remove endotoxins and other minute impurities. During filtration, the flow guiding component evenly distributes the material and presses the filter membrane, while sealing gaskets and drain outlets ensure a tight seal and proper drainage. The final treated material is output through a closed, sterile pipeline, eliminating external contamination throughout the entire process and meeting aseptic production requirements.
[0021] The above description is only a preferred embodiment of the present utility model, but the protection scope of the present utility model is not limited thereto. Any equivalent substitutions or changes made by those skilled in the art within the technical scope disclosed in the present utility model, based on the technical solution and the inventive concept of the present utility model, should be included within the protection scope of the present utility model.
Claims
1. A sterilization treatment device, comprising a reaction vessel (1) fixedly installed on the ground, a raw material filter cartridge (2), and a reaction liquid post-filter cartridge (3), characterized in that, The outlet of the raw material filter cartridge (2) is connected to the inlet of the reactor (1) through a pipe (4) and a delivery pump (5), and the outlet of the reactor (1) is connected to the inlet of the reaction liquid filter cartridge (3) through a pipe (4) and a delivery pump (5). The inner wall of the raw material filter cylinder (2) is fixedly connected with a placement strip (6), a filter membrane (7) is installed on the placement strip, and a flow guiding component (8) is provided on the filter membrane (7) to press and stabilize the filter membrane (7). The reaction liquid filter cylinder (3) is provided with the same filter membrane (7) and flow guiding component (8) as the raw material filter cylinder (2).
2. The sterilization treatment device according to claim 1, characterized in that, The top opening of the raw material filter cylinder (2) is threadedly connected to a cylinder cover (9) with a feeding hopper, and the top opening of the reaction liquid filter cylinder (3) is threadedly connected to a sealing cap (10).
3. The sterilization treatment device according to claim 1, characterized in that, The top edge of the filter membrane (7) is provided with an installation groove (11), a sealing gasket (12) is provided on the installation groove (11), and a drain outlet (13) is provided on the inner wall of the installation groove (11).
4. The sterilization treatment device according to claim 1, characterized in that, The flow guiding assembly (8) includes a flow guiding box (14) installed above the filter membrane (7). A screw (15) is fixedly connected to one side of the top of the flow guiding box (14), and a fixing rod (16) is fixedly connected to the other side of the top of the flow guiding box (14). A rotating cylinder (17) is threaded onto the screw (15), and a sliding cylinder (18) is sleeved on the fixing rod (16). A top plate (19) is fixedly connected to the top of the sliding cylinder (18).
5. The sterilization treatment device according to claim 4, characterized in that, The screw (15), the fixing rod (16) and the top plate (19) are each provided in a pair. The top of the rotating cylinder (17) is rotatably connected to the bottom of the top plate (19). The screw (15) and the fixing rod (16) are symmetrically distributed.
6. The sterilization treatment device according to claim 1, characterized in that, The filter membrane (7) on the raw material filter cylinder (2) is a 0.45-micrometer microporous filter membrane, the filter membrane (7) on the reaction liquid filter cylinder (3) is a 0.22-micrometer microporous filter membrane, and the connecting pipe (4) between the reaction vessel (1), the raw material filter cylinder (2) and the reaction liquid filter cylinder (3) is a closed sterile pipe.