Aseptic filling system for high-viscosity pharmaceutical solutions with end-to-end constant temperature control

Abstract

This application relates to a high-viscosity liquid aseptic filling system with end-to-end constant temperature control, including a liquid transfer assembly, an end-to-end heating assembly, a frame, and a clearance mechanism. The end-to-end heating assembly provides continuous heating and insulation for the liquid transfer assembly and is mounted on the frame via the clearance mechanism. The clearance mechanism can switch between an assembly position and a working position. In the assembly position, it drives the heating assembly out of a predetermined space, providing a sterile, isolated operating space for tubing connection and solving the technical problem of heating structures interfering with assembly within a confined sterile chamber. The pump unit adopts a U-shaped groove design with heat-conducting blocks, achieving efficient heat conduction and convenient lateral snap-fit ​​installation. For the reciprocating filling needle holder, a fixed heating chamber provides a constant temperature environment for the moving flexible infusion tubing, avoiding mechanical interference.

Description

Technical Field

[0001] This application relates to the field of filling equipment technology, and in particular to a high-viscosity liquid aseptic filling system with end-to-end constant temperature control. Background Technology

[0002] In the aseptic filling production of high-viscosity pharmaceutical solutions, the solutions usually need to be kept in a specific high-temperature environment to maintain fluidity, thereby ensuring filling accuracy and smooth delivery.

[0003] However, in pharmaceutical processes, aseptic filling typically needs to be carried out within a sterile isolator or a sealed sterile chamber, and operators must perform the work while wearing gloves on the isolator. Existing end-to-end heating and insulation systems typically have large heaters that are fixedly mounted on the equipment rack, occupying valuable space within the sterile chamber. This results in insufficient operating space for operators to connect pipe joints while wearing gloves, making installation extremely difficult. Summary of the Invention

[0004] To address the aforementioned issues, this application provides a high-viscosity pharmaceutical aseptic filling system with end-to-end constant temperature control that resolves spatial interference between the heating components and pipeline assembly operations under aseptic isolation conditions.

[0005] To achieve the above objectives, this application designs a fully temperature-controlled aseptic filling system for high-viscosity pharmaceutical solutions, comprising: The drug solution transfer assembly includes a distribution pipe, a drug solution pump group, an infusion pipe and a filling needle holder connected in sequence, wherein at least a portion of the infusion pipe is a flexible pipe. A full-process heating component is located around the liquid medicine transfer component and is used to heat and keep the liquid medicine flowing through the liquid medicine transfer component throughout the entire process. A frame and a clearance mechanism, wherein at least a portion of the full-process heating assembly is mounted on the frame via the clearance mechanism; The clearance mechanism is configured to switch between an assembly state and a working state. When in the assembly state, the clearance mechanism drives the corresponding full-process heating component to move out of the predetermined space to expose the pipeline connection point of the liquid transfer component; When in the working state, the full-process heating component is reset and wrapped around the outside of the liquid transfer component.

[0006] Preferably, the yielding mechanism is a manually adjustable mechanism, and the outer side of the full-process heating assembly is provided with an operating handle wheel for the operator to grip while wearing gloves inside the sterile isolator, so that the yielding mechanism can be manually switched between the assembly state and the working state.

[0007] Preferably, the full-process heating assembly includes a heat-conducting block covering the outer periphery of the liquid pump group, and an electric heating element is provided inside the heat-conducting block; the heat-conducting block has a U-shaped groove that matches the outer contour of the liquid pump group; the pump body of the liquid pump group is laterally inserted into and tightly fitted into the U-shaped groove, so as to achieve heat conduction heating through the heat-conducting block.

[0008] Preferably, the clearance mechanism includes a first clearance mechanism located on one side of the inlet end of the liquid pump group, the distribution pipe is installed on the first clearance mechanism, and the first clearance mechanism has a vertical lifting freedom. When in the assembled state, the first clearance mechanism drives the dispensing pipe and its associated heating assembly to descend downwards to expose the inlet end of the liquid pump assembly.

[0009] Preferably, the clearance mechanism includes a second clearance mechanism located on one side of the outlet end of the liquid pump assembly, the second clearance mechanism including a sliding track and / or a flip hinge; When in the assembled state, the heating component on the outlet side of the liquid pump assembly slides via the sliding rail and / or flips via the flip hinge to expose the outlet end of the liquid pump assembly.

[0010] Preferably, the full-process heating assembly further includes a fixed heating cavity disposed between the drug pump group and the filling needle holder; the flexible tubing of the infusion tube is accommodated in the internal space of the fixed heating cavity so that the flexible tubing is in a constant temperature heating environment.

[0011] Preferably, the inner diameter of the fixed heating cavity is larger than the outer diameter of the flexible tube, one end of the flexible tube is fixed to the inlet end of the fixed heating cavity, and the other end floats in the fixed heating cavity with the reciprocating motion of the filling needle holder.

[0012] Preferably, a movable cover plate is provided on one side of the fixed heating cavity. The movable cover plate is connected to the fixed heating cavity through a locking assembly or a hinge structure to open the fixed heating cavity in the assembled state.

[0013] Preferably, the full-process heating assembly includes a metal thermally conductive substrate, which has mounting holes for mounting electric heating elements and temperature sensing holes for mounting temperature sensors; the electric heating elements and temperature sensors are electrically connected to an external control system, which is configured to adjust the heating power of the electric heating elements according to the feedback signal of the temperature sensor to achieve closed-loop constant temperature control; the outer surface of the full-process heating assembly is provided with a heat insulation protective layer.

[0014] Preferably, the liquid medicine pump assembly is configured as an independent module; when the system is in the assembled state, the independent module consisting of the liquid medicine pump assembly can be inserted as a whole into the predetermined position of the frame; The inlet end of the liquid pump unit is provided with a first quick-connect interface for sealing and connecting with the opening of the distribution pipe; The outlet end of the drug pump set is provided with a second quick-connect interface for sealing and connecting with the infusion tube opening; After being placed into the frame, the independent module is fixed and connected to the distribution tube and the infusion tube respectively through the first quick-connect interface and the second quick-connect interface.

[0015] The high-viscosity pharmaceutical aseptic filling system designed in this application features a fully temperature-controlled process. By incorporating a clearance mechanism connected to the frame, the heating component can switch between assembly and operational states. In the assembly state, sufficient physical space is provided for pipeline connection, solving the technical challenge of interference during assembly of the heating component within the confined space of the aseptic isolator. The U-shaped groove of the heat-conducting block, tightly fitting the pump body, achieves efficient heat conduction and convenient installation of the pharmaceutical flow components. The fixed heating chamber provides a constant temperature environment for the flexible tubing moving with the filling needle holder, ensuring uniform heating while avoiding mechanical interference from the moving mechanism. By configuring the pharmaceutical pump unit as an independent module with quick-connect interfaces, the assembly and maintenance process in an aseptic environment is simplified, achieving precise temperature control of the high-viscosity pharmaceutical solution throughout the entire process, thus improving the operational efficiency and aseptic assurance level of the filling system. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the structure of the high-viscosity pharmaceutical liquid aseptic filling system with end-to-end constant temperature control provided in the embodiments of this application. Figure 1 .

[0017] Figure 2 This is a schematic diagram of the structure of the high-viscosity pharmaceutical liquid aseptic filling system with end-to-end constant temperature control provided in the embodiments of this application. Figure 2 .

[0018] Figure 3 This is a schematic diagram of the structure of the first yielding mechanism provided in the embodiments of this application.

[0019] Figure 4 yes Figure 3 Enlarged diagram of point A in the middle.

[0020] Figure 5 This is a schematic diagram of the structure of the liquid pump assembly provided in the embodiments of this application.

[0021] Figure 6 This is a schematic diagram of the first yielding mechanism provided in the embodiments of this application.

[0022] Figure 7 This is a schematic diagram of the structure of the second yielding mechanism provided in the embodiments of this application.

[0023] Figure 8 This is a schematic diagram of the structure of the fixed heating cavity provided in the embodiment of this application.

[0024] Figure 9 yes Figure 8 Enlarged diagram of point B in the middle.

[0025] Figure 10 This is a schematic diagram of the arrangement of the full-process heating assembly on the filling needle holder side provided in the embodiments of this application.

[0026] The components include: liquid medicine transfer assembly 10, distribution pipe 11, liquid medicine pump set 12, inlet end 121, outlet end 122, infusion pipe 13, flexible pipeline 131, vertical section 132, filling needle holder 14, liquid medicine tank 15, full-process heating assembly 20, operating handle wheel 21, heat-conducting block 22, U-shaped groove 221, metal heat-conducting substrate 23, frame 30, first clearance mechanism 40, first base 41, transmission mechanism 42, limit block 43, second clearance mechanism 60, second base 61, slide rail 62, support platform 63, box 64, transmission assembly 65, pull rod 66, fixed heating cavity 70, and movable cover plate 71. Detailed Implementation

[0027] The preferred embodiments of this application are described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are for illustration and explanation only and are not intended to limit this application.

[0028] See Figures 1 to 10 This embodiment provides a high-viscosity drug solution aseptic filling system with full-process constant temperature control, which is mainly used for aseptic filling of high-viscosity drug solutions that are sensitive to temperature and easily thicken and solidify at room temperature.

[0029] See Figure 1 , Figure 2 The system mainly includes a liquid transfer assembly 10, a full-process heating assembly 20, a frame 30, and a clearance mechanism. Specifically, the liquid transfer assembly 10 constitutes the main flow channel for liquid delivery, and includes a distribution pipe 11, a liquid pump assembly 12, an infusion pipe 13, and a filling needle holder 14 connected in sequence. To meet the requirements of the filling operation, at least a portion of the infusion pipe 13 is configured as a flexible conduit 131. The full-process heating assembly 20 is located around the liquid transfer assembly 10 and is used to heat and maintain the temperature of the liquid flowing through the liquid transfer assembly 10 throughout the entire process, ensuring that the high-viscosity liquid maintains the required fluidity throughout the entire delivery path.

[0030] In this embodiment, the full-process heating assembly 20 is not directly fixed, but is at least partially mounted on the frame 30 via the clearance mechanism; wherein, the clearance mechanism is configured to switch between an assembled state and an operating state. When the system is in the assembled state, the clearance mechanism drives the corresponding full-process heating component 20 to move out of the predetermined space to expose the pipeline connection point of the liquid transfer component 10, that is, to fully expose the inlet end 121 and outlet end 122 of the liquid pump group 12, thereby providing the operator with an unobstructed operating space to connect the inlet end 121 and outlet end 122 of the liquid pump group 12 in a sterile isolation environment.

[0031] Once the pipeline connection is complete, the system switches to the aforementioned working state. At this time, the full-process heating component 20 resets and tightly wraps around the outside of the drug flow component 10, restoring the constant temperature heating function. This solves the problem of the fully enclosed heating structure interfering with pipeline assembly within the confined space of the sterile isolator.

[0032] In some embodiments, the yielding mechanism is configured as a manually adjustable mechanism; correspondingly, an operating handle 21 is provided on the outside of the full-process heating assembly 20 for the operator to grip while wearing gloves inside the aseptic isolator (not shown). That is, during production, the aseptic filling system provided in this embodiment is placed inside the aseptic isolator in an aseptic isolation environment, and the operator can easily manually switch the yielding mechanism between the assembly state and the working state by applying force to the operating handle 21 while wearing gloves.

[0033] In some embodiments, see Figure 1 , Figure 2 The drug solution transfer assembly 10 also includes a drug solution tank 15 upstream of the distribution pipe 11. The drug solution tank 15 is entirely disposed inside the sterile isolator and is used to receive and buffer the high-viscosity initial drug solution introduced from the external system. The drain port of the drug solution tank 15 is fluidly connected to the inlet end of the distribution pipe 11, so that the buffered drug solution can be distributed into the distribution pipe 11 in a multi-channel distribution mode. For example, a one-in-five-out distribution structure can be used to divide the drug solution into five channels and deliver them to the corresponding branches of the drug solution pump group 12.

[0034] To ensure the rheological properties of the medicine solution during the buffering stage, the full-process heating assembly 20 also includes a tank heating and temperature control unit located around the medicine solution tank 15. This unit covers the outer surface of the medicine solution tank 15 and is equipped with an electric heating element and a temperature sensor. Furthermore, the exterior of the tank heating and temperature control unit is covered with a heat insulation layer. The tank heating and temperature control unit is electrically connected to an external control system, thereby preheating and maintaining the externally introduced medicine solution within a set temperature range, ensuring sufficient and stable flowability of the medicine solution before it enters the distribution pipe 11 and the medicine solution pump assembly 12.

[0035] In some embodiments, see Figure 4 The full-process heating assembly 20 includes a heat-conducting block 22 covering the outer periphery of the liquid pump assembly 12, and an electric heating element is provided inside the heat-conducting block 22. Specifically, the heat-conducting block 22 has a U-shaped groove 221 that matches the outer contour of the liquid pump assembly 12; during assembly, the pump body of the liquid pump assembly 12 can be laterally inserted and tightly fitted into the U-shaped groove 221, thereby avoiding cumbersome perforation and docking operations, and achieving efficient heat conduction heating through the heat-conducting block 22.

[0036] Furthermore, in order to achieve assembly clearance between the interfaces at both ends of the liquid pump assembly 12, the clearance mechanism specifically includes a first clearance mechanism 40 and a second clearance mechanism 60 located on both sides of the pump assembly: A first clearance mechanism 40 located on one side of the inlet end 121 of the liquid medicine pump assembly 12 has a vertical lifting freedom, and the distribution pipe 11 is mounted on the first clearance mechanism 40. When in the assembled state, the first clearance mechanism 40 drives the distribution pipe 11 and its attached heating assembly to descend downwards, so as to suspend it in the air to make way for the operating area and fully expose the inlet end 121 of the liquid medicine pump assembly 12.

[0037] In one specific embodiment, see Figure 3 , Figure 5 , Figure 6 The first yielding mechanism 40 includes a first base 41, a transmission mechanism 42, and a handwheel as an operating handle 21. The distribution pipe 11 is mounted on the first base 41, and the first base 41 and the distribution pipe 11 are surrounded by corresponding full-process heating components 20 to heat and keep the liquid medicine in the distribution pipe 11 warm. The first base 41 is vertically and vertically mounted on the frame 30. The handwheel is rotatably disposed at the bottom of the frame 30. The transmission mechanism 42 is connected between the handwheel and the first base 41, and the transmission mechanism 42 is configured to convert the rotational motion of the handwheel into the vertical lifting motion of the first base 41.

[0038] In specific implementation, to ensure that the first base 41 can be vertically and stably mounted on the frame 30, at least two guide rods are vertically fixed on the frame 30. The first base 41 is provided with guide sleeves adapted to the guide rods, which slide along the guide rods. A handwheel is rotatably mounted on the bottom of the frame 30, and a transmission mechanism 42 connects the handwheel and the first base 41. In this embodiment, the transmission mechanism 42 is configured as a screw drive assembly, which includes a reversing gearbox, a vertically mounted screw, and a nut threaded into the screw. The drive shaft of the handwheel is horizontally connected to the input end of the reversing gearbox, the screw is connected to the output end of the reversing gearbox, and the nut is fixedly mounted on the bottom of the first base 41. The rotational motion of the handwheel, after the reversing gearbox changes the transmission direction, drives the screw to rotate, which is then converted into the vertical lifting motion of the first base 41 along the guide rods via the nut.

[0039] Furthermore, to ensure accuracy during assembly and repositioning, a limiting block 43 is fixedly installed on the liquid pump assembly 12. This limiting block 43 is located on the vertical upward path of the first base 41 and is used to limit the maximum upward height of the first base 41. When the system is in the assembly state and it is necessary to connect the distribution pipe 11 to the inlet end 121 of the liquid pump assembly 12, the operator drives the transmission mechanism 42 by rotating the handwheel, causing the first base 41 to lower the distribution pipe 11 and the corresponding full-process heating assembly 20 as a whole, thereby fully exposing the inlet end 121 of the liquid pump assembly 12 and providing unobstructed operating space for pipe connection. When the system switches to the working state after the pipe connection is completed, the operator rotates the handwheel in the opposite direction to drive the first base 41 to rise until the first base 41 abuts against the limiting block 43. At this time, the full-process heating assembly 20 is accurately repositioned and completes the wrapping of the pipe connection.

[0040] The second clearance mechanism 60, located on one side of the outlet end 122 of the liquid pump assembly 12, includes a sliding rail and / or a flip hinge. In the assembled state, the operator operates the handle wheel 21 to slide the heating assembly on the outlet end 122 side of the liquid pump assembly 12 via the sliding rail and / or flip it outward via the flip hinge, thereby providing the space required to mate the outlet end 122 of the liquid pump assembly 12 with the infusion tube 13 and exposing the outlet end 122.

[0041] In this embodiment, the specific structure of the second clearance mechanism 60 located on the side of the outlet end 122 of the liquid pump group 12 can be the same as the structure of the first clearance mechanism 40, that is, it adopts a vertical lifting clearance transmission method.

[0042] In some embodiments, see Figure 1 , Figure 2 , Figure 8 , Figure 10The filling needle holder 14 is configured to reciprocate up and down relative to the frame 30 to perform the filling action. The full-process heating assembly 20 also includes a fixed heating chamber 70 disposed between the drug pump assembly 12 and the filling needle holder 14. The flexible tubing 131 of the infusion tube 13 is housed within the internal space of the fixed heating chamber 70, so that the flexible tubing 131 remains in a constant heating environment when the filling needle holder 14 moves up and down.

[0043] To prevent mechanical interference, the inner diameter of the fixed heating cavity 70 is larger than the outer diameter of the flexible tube 131; one end of the flexible tube 131 is fixed to the inlet end of the fixed heating cavity 70, and the other end floats and bends freely within the fixed heating cavity 70 with the reciprocating motion of the filling needle holder 14, so as to prevent heat loss and motion interference during the dynamic filling process.

[0044] In this embodiment, a movable cover plate 71 is provided on one side of the fixed heating cavity 70. The movable cover plate 71 is connected to the fixed heating cavity 70 through a locking assembly or a hinge structure. In the assembled state, the operator can easily open the movable cover plate 71 through the gloves on the isolator to insert the flexible pipeline 131.

[0045] In another embodiment, see Figure 8 , Figure 9 Considering that the drug pump assembly 12 is arranged horizontally, and the filling needle holder 14 needs to perform vertical reciprocating motion during the filling operation, in order to reduce bending fatigue and mechanical damage to the flexible tubing 131 of the infusion tube 13 caused by the up-and-down movement of the filling needle holder 14, the fixed end of the flexible tubing 131 and the follower end connected to the filling needle holder 14 are preferably set at the same horizontal height. For this purpose, after the infusion tube 13 is led out from the outlet end 122 of the drug pump assembly 12, it forms an upwardly extending vertical section 132. The upper end of this vertical section 132 is fixed in the internal space of the fixed heating cavity 70, and then bends horizontally to form the flexible tubing 131.

[0046] To accommodate the spatial layout of the aforementioned vertical segment 132, please refer to... Figure 7 , Figure 9The second clearance mechanism 60 is configured as a composite clearance structure combining horizontal sliding and flip-top mechanisms. Specifically, the second clearance mechanism 60 includes a second base 61 vertically slidably mounted on the frame 30. A support platform 63 is slidably mounted on the second base 61 via a slide rail 62. A housing 64 is fixedly mounted on the top of the support platform 63. A handwheel is provided on the frame 30, and the handwheel is connected to a horizontally extending transmission component 65. The output end of the transmission component 65 is connected to the second base 61 to convert the rotational drive of the handwheel into the vertical lifting and lowering movement of the second base 61, thereby clearing the outlet end 122 of the exposed liquid pump assembly 12. In addition, a pull rod 66 is provided on the side of the support platform 63 to apply external force to the support platform 63.

[0047] Furthermore, at least a portion of the vertical section 132 and the inlet end of the infusion tube 13 are housed within the enclosure 64. The full-process heating assembly 20 is disposed outside the enclosure 64 to provide all-around heating and insulation for the internal vertical section 132. To facilitate assembly operations within the sterile chamber and to accommodate the fixing of the vertical pipeline, a hinged flap 67 is provided on the front side of the enclosure 64.

[0048] When the system is in the assembly state, the operator uses the pull rod 66 to slide the housing 64, along with the support platform 63, horizontally relative to the second base 61 via the slide rail 62. Then, the operator opens the flip cover 67 on the front of the housing 64, fully exposing the internal piping connection space. In this state, the operator can connect the inlet end of the infusion tube 13 to the outlet end 122 of the drug pump unit 12 without interference, and securely arrange the vertical section 132 inside the housing 64. After assembly and piping fixation, the operator closes the flip cover 67 and reverses the handwheel to horizontally slide the support platform 63 and housing 64 back to the working state, thus completing the sealing and temperature control of the drug outlet flow channel.

[0049] Further, see Figure 8 , Figure 10 The full-process heating components 20 are arranged on both opposite sides of the filling needle holder 14. The two oppositely arranged full-process heating components 20 maintain a set distance to form a reciprocating motion space for the filling needles on the filling needle holder 14 to move vertically up and down. The filling needles move up and down within this reciprocating motion space to perform the filling operation.

[0050] To meet the requirements of a high-level aseptic process environment, the tops of the full-process heating components 20 located on both sides of the filling needle are open without structural obstruction, creating a vertical airflow channel with an open top in the reciprocating motion space. This vertical airflow channel is configured to allow clean air or laminar airflow inside the aseptic isolator to pass smoothly from top to bottom, thereby effectively avoiding the risk of local laminar flow blockage or eddies caused by equipment structural interference, and ensuring a dynamic aseptic environment in the core filling area.

[0051] In some embodiments, see Figure 4 , Figure 9 The full-process heating assembly 20 includes a metal thermally conductive substrate 23, such as an aluminum substrate. The metal thermally conductive substrate 23 has mounting holes for installing electric heating elements and temperature sensing holes for installing temperature sensors. Both the electric heating elements and the temperature sensors are electrically connected to an external control system. The control system is configured to precisely adjust the heating power of the corresponding electric heating elements based on the feedback signal from the temperature sensors, achieving independent closed-loop constant temperature control for each section. Simultaneously, the outer surface of the full-process heating assembly 20 is provided with a heat-insulating protective layer, which reduces heat loss to the external sterile environment and protects operators from burns.

[0052] In some embodiments, see Figure 3 , Figure 5 To further improve assembly efficiency under aseptic conditions, the drug pump assembly 12 in this embodiment is configured as an independent module that can be pre-assembled. When the system is in the assembly state, the independent module consisting of the drug pump assembly 12 can be inserted into the predetermined position of the frame 30 in one go. In conjunction with this modular design, the inlet end 121 of the drug pump assembly 12 is provided with a first quick-connect interface for sealing connection with the outlet of the distribution pipe 11; the outlet end 122 of the drug pump assembly 12 is provided with a second quick-connect interface for sealing connection with the outlet of the infusion pipe 13. After the independent module is inserted into the frame 30, it can be fixed and connected to the distribution pipe 11 and the infusion pipe 13 respectively through the first quick-connect interface and the second quick-connect interface, effectively simplifying the on-site assembly process of the equipment within the isolator.

[0053] The high-viscosity pharmaceutical aseptic filling system with end-to-end constant temperature control provided in this application embodiment, through the setting of a clearance mechanism connected to the frame, allows the heating component to switch between an assembly state and an operating state. In the assembly state, sufficient physical space is provided for pipeline connection, solving the technical challenge of interference during assembly of the heating component within the confined space of the aseptic isolator. The design of the U-shaped groove of the heat-conducting block tightly fitting the pump body achieves efficient heat conduction and convenient installation of the pharmaceutical flow component. The fixed heating chamber provides a constant temperature environment for the flexible tubing moving with the filling needle holder, ensuring heating uniformity while avoiding mechanical interference from the moving mechanism. By configuring the pharmaceutical pump unit as an independent module with a quick-connect interface, the assembly and maintenance process of the equipment in an aseptic environment is simplified, achieving precise constant temperature control of the high-viscosity pharmaceutical solution throughout the entire process, improving the operating efficiency and aseptic assurance level of the filling system.

[0054] In the description of this application, it should be noted that the terms "vertical", "up", "down", "horizontal", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0055] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0056] Finally, it should be noted that the above descriptions are merely preferred embodiments of this application and are not intended to limit this application. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A high-viscosity pharmaceutical liquid aseptic filling system with end-to-end constant temperature control, characterized in that, include: The drug solution transfer assembly includes a distribution pipe, a drug solution pump group, an infusion pipe and a filling needle holder connected in sequence, wherein at least a portion of the infusion pipe is a flexible pipe. A full-process heating component is located around the liquid medicine transfer component and is used to heat and keep the liquid medicine flowing through the liquid medicine transfer component throughout the entire process. A frame and a clearance mechanism, wherein at least a portion of the full-process heating assembly is mounted on the frame via the clearance mechanism; The clearance mechanism is configured to switch between an assembly state and a working state. When in the assembly state, the clearance mechanism drives the corresponding full-process heating component to move out of the predetermined space to expose the pipeline connection point of the liquid transfer component; When in the working state, the full-process heating component is reset and wrapped around the outside of the liquid transfer component.

2. The aseptic filling system for high-viscosity pharmaceutical solutions with end-to-end constant temperature control according to claim 1, characterized in that, The yielding mechanism is a manually adjustable mechanism, and the outer side of the full-process heating assembly is provided with an operating handle wheel for the operator to grip while wearing gloves inside the sterile isolator, so that the yielding mechanism can be manually switched between the assembly state and the working state.

3. The aseptic filling system for high-viscosity pharmaceutical solutions with end-to-end constant temperature control according to claim 1, characterized in that, The full-process heating assembly includes a heat-conducting block covering the outer periphery of the liquid pump group, and an electric heating element is provided inside the heat-conducting block; a U-shaped groove adapted to the outer contour of the liquid pump group is opened on the heat-conducting block; the pump body of the liquid pump group is laterally inserted and tightly fitted into the U-shaped groove, so as to achieve heat conduction heating through the heat-conducting block.

4. The high-viscosity pharmaceutical liquid aseptic filling system with end-to-end constant temperature control according to claim 3, characterized in that, The clearance mechanism includes a first clearance mechanism located on one side of the inlet end of the liquid pump group, the distribution pipe is installed on the first clearance mechanism, and the first clearance mechanism has a vertical lifting degree of freedom. When in the assembled state, the first clearance mechanism drives the dispensing pipe and its associated heating assembly to descend downwards to expose the inlet end of the liquid pump assembly.

5. The high-viscosity pharmaceutical liquid aseptic filling system with end-to-end constant temperature control according to claim 3, characterized in that, The clearance mechanism includes a second clearance mechanism located on one side of the outlet end of the liquid pump assembly, the second clearance mechanism including a sliding track and / or a flip hinge; When in the assembled state, the heating component on the outlet side of the liquid pump assembly slides via the sliding rail and / or flips via the flip hinge to expose the outlet end of the liquid pump assembly.

6. The high-viscosity pharmaceutical liquid aseptic filling system with end-to-end constant temperature control according to claim 1, characterized in that, The full-process heating assembly also includes a fixed heating cavity located between the drug pump group and the filling needle holder; the flexible tubing of the infusion tube is housed in the internal space of the fixed heating cavity so that the flexible tubing is in a constant temperature heating environment.

7. The aseptic filling system for high-viscosity pharmaceutical solutions with end-to-end constant temperature control according to claim 6, characterized in that, The inner diameter of the fixed heating cavity is larger than the outer diameter of the flexible tube. One end of the flexible tube is fixed to the inlet end of the fixed heating cavity, and the other end floats in the fixed heating cavity with the reciprocating motion of the filling needle holder.

8. The aseptic filling system for high-viscosity pharmaceutical solutions with end-to-end constant temperature control according to claim 6, characterized in that, A movable cover plate is provided on one side of the fixed heating cavity. The movable cover plate is connected to the fixed heating cavity through a locking assembly or a hinge structure to open the fixed heating cavity in the assembled state.

9. The aseptic filling system for high-viscosity pharmaceutical solutions with end-to-end constant temperature control according to claim 1, characterized in that, The full-process heating assembly includes a metal thermally conductive substrate, which has mounting holes for installing electric heating elements and temperature sensing holes for installing temperature sensors. The electric heating elements and temperature sensors are electrically connected to an external control system, which is configured to adjust the heating power of the electric heating elements according to the feedback signal of the temperature sensor to achieve closed-loop constant temperature control. The outer surface of the full-process heating assembly is provided with a heat insulation protective layer.

10. The aseptic filling system for high-viscosity pharmaceutical solutions with end-to-end constant temperature control according to claim 2, characterized in that, The liquid medicine pump unit is configured as an independent module; when the system is in the assembly state, the independent module consisting of the liquid medicine pump unit can be placed into the predetermined position of the frame as a whole; The inlet end of the liquid pump unit is provided with a first quick-connect interface for sealing and connecting with the opening of the distribution pipe; The outlet end of the drug pump set is provided with a second quick-connect interface for sealing and connecting with the infusion tube opening; After being placed into the frame, the independent module is fixed and connected to the distribution tube and the infusion tube respectively through the first quick-connect interface and the second quick-connect interface.

Images