Lyophilized powder injection and sterilization system

Abstract

The utility model relates to the technical field of medicine production equipment, concretely is freeze-dried powder injection material suction and sterilization system, including displacement track and laminar flow discharge trolley, laminar flow discharge trolley can move along displacement track, move back and forth between freeze-drier discharge port and gun head sterilizer, drive slide rail and slide are arranged in laminar flow discharge trolley, and the discharge gun head is connected on slide, drive slide rail and slide cooperate action, can drive discharge gun head to enter and exit laminar flow discharge trolley, and cooperate suction with freeze-drier discharge port, or cooperate and carry out sterilization treatment with gun head sterilizer. The utility model can automatically realize the aseptic discharge of freeze-dried injection medicine powder and the sterilization process of discharge gun head: when the discharge gun head completes batch production, automatically transfers to the sterilization station through the hundred level laminar flow discharge trolley, accurately docks with the sterilizer tank body and is automatically locked, carries out sterilization operation in the closed aseptic operation system, the whole process does not need manual intervention, effectively avoids the pollution risk brought by manual operation.

Description

Technical Field

[0001] This utility model relates to the field of pharmaceutical production equipment technology, specifically to a freeze-dried powder injection feeding and sterilization system. Background Technology

[0002] In the production of lyophilized powder injections, the vacuum suction nozzle must be thoroughly cleaned and sterilized after each batch. Traditional suction and cleaning processes have the following drawbacks:

[0003] First, there is a lot of human intervention: In the existing technology, operators need to disassemble, transfer and load the nozzles, which introduces 3-5 human intervention risks per batch on average, which cannot meet the "zero intervention" requirement of GMP Annex 1 for the aseptic core area;

[0004] Secondly, during the material suction process, the freeze-dried material is prone to clump together too large, causing blockages when the nozzle is suctioned.

[0005] Third, sterilization is incomplete: Existing technologies mostly use hydrogen peroxide for sterilization, which is prone to forming sterilization dead zones due to the complex structure of the nozzle (the measured F0 value fluctuates by ±15%), resulting in poor sterilization effect;

[0006] Fourth, it is inefficient: the sterilization cycle of existing technologies is as long as 4-6 hours and requires an additional drying process. Utility Model Content

[0007] The technical problem to be solved by this utility model is to overcome the defects of the prior art and provide a freeze-dried powder injection feeding and sterilization system, which is particularly suitable for the aseptic production of highly active and highly allergenic active pharmaceutical ingredients.

[0008] To solve the above-mentioned technical problems, this utility model provides the following technical solution:

[0009] The freeze-dried powder injection feeding and sterilization system includes a displacement track and a laminar flow discharge cart. The laminar flow discharge cart can move along the displacement track and move back and forth between the freeze dryer outlet and the nozzle sterilizer. The laminar flow discharge cart is equipped with a drive slide rail and a slide seat. The discharge nozzle is connected to the slide seat. The drive slide rail and the slide seat cooperate to drive the discharge nozzle in and out of the laminar flow discharge cart to feed the freeze dryer outlet or to sterilize it in conjunction with the nozzle sterilizer.

[0010] In the above structure, the laminar flow discharge cart moves the discharge nozzle to the suction station, that is, to the freeze dryer's outlet. After the cabinet door aligns, the discharge nozzle sucks up material from the freeze dryer's raw material tray. The freeze-dried powder injection enters the raw material storage tank for storage. After the suction operation is completed, the laminar flow discharge cart moves the nozzle to the sterilization station, that is, the nozzle sterilizer, for sterilization. Throughout this process, there is no need to disassemble the nozzle; the laminar flow discharge cart transports it back and forth, avoiding human intervention and thus achieving the "zero intervention" requirement for the sterile core area.

[0011] The discharge gun head includes a gun head suction pipe, one end of which is connected to an automatic suction gun head. A crushing wheel is provided at the suction port of the automatic suction gun head, and the crushing wheel is connected to a drive mechanism, which can drive the crushing wheel to rotate.

[0012] The crushing wheel can pre-crush the freeze-dried powder injection before it enters the automatic feeding gun head, so that the freeze-dried powder injection can quickly enter the automatic feeding gun head and avoid blockage.

[0013] The driving mechanism includes a motor. The end of the suction pipe away from the automatic suction gun head is externally connected to the motor. The output end of the motor is connected to a transmission rod. The end of the transmission rod away from the motor is rotatably connected to the automatic suction gun head and is fixedly connected to a first bevel gear. The first bevel gear meshes with a second bevel gear. The second bevel gear is rotatably positioned on one side of the automatic suction gun head. The second bevel gear is connected to a transmission gear set. The transmission gear set is connected to the crushing wheel and is rotatably positioned on one side of the automatic suction gun head.

[0014] In the above structure, the motor drives the transmission rod to rotate, the transmission rod drives the first bevel gear to rotate, the first bevel gear meshes with the second bevel gear, changing the direction of the transmission power, thereby transmitting the power to the transmission gear set, and the transmission gear set drives the crushing wheel to rotate.

[0015] The crushing wheel includes a central shaft and several crushing teeth, and the central shaft is used to connect with the transmission gear set.

[0016] An air blowing pipe is provided on the outside of the suction pipe of the gun head. The output end of the air blowing pipe is located close to the automatic suction gun head. The air blowing pipe blows nitrogen gas into the suction port of the automatic suction gun head, which helps the freeze-dried powder injection crushed by the crushing wheel to enter the automatic suction gun head.

[0017] The sterilizer includes a sterilizer tank, which is equipped with a pure steam inlet, a pure steam spray pipe, and a condensate outlet.

[0018] Pure steam, entering through the pure steam inlet, is sprayed through the pure steam spray pipe, ensuring effective cleaning of both the inner and outer walls and efficient heat distribution.

[0019] The sterilizer tank is equipped with a cap at one end and an automatic door at the other end. The automatic door is connected to a door-pushing cylinder. The sterilizer tank is also equipped with a gun head support with several through holes.

[0020] The nozzle suction pipe is fixedly connected to a nozzle sterilization chamber door panel, which can cooperate with the automatic door of the nozzle sterilizer to seal the nozzle sterilizer.

[0021] The sterilizer tank is connected to a temperature probe interface; the sterilizer tank is also connected to an air inlet hose, which is connected to nitrogen gas, so that the sterilizer tank can be purged and dried after sterilization.

[0022] The end of the suction tube away from the automatic suction gun head is provided with a quick-connect port, which is connected to the raw material storage tank through a hose.

[0023] The beneficial effects achieved by this utility model are:

[0024] This invention enables fully automated aseptic dispensing of freeze-dried injectable active pharmaceutical ingredients (APIs) and sterilization of the dispensing nozzle: after batch production, the dispensing nozzle is automatically transferred to the sterilization station via a Class 100 laminar flow dispensing cart, precisely docking with and automatically locking into the sterilizer tank. A closed, aseptic operating system then performs the sterilization operation. After sterilization, the API can be directly used for the next batch. The entire process requires no manual intervention, effectively avoiding the contamination risks associated with manual operation, significantly improving the safety and reliability of aseptic API production, and substantially increasing production efficiency and system stability.

[0025] The automatic suction gun head of this utility model is equipped with a crushing wheel at the suction port, which can pre-crush the freeze-dried powder injection before it enters the automatic suction gun head, so that the freeze-dried powder injection can quickly enter the automatic suction gun head.

[0026] This invention uses high-temperature steam sterilization, shortening the pure steam penetration time to 8 minutes (compared to 45 minutes in the traditional process), stabilizing F0 at 18±0.5, ensuring high sterilization reliability, and reducing the sterilization and drying cycle to 1.5 hours, thus increasing equipment utilization by 300%. Attached Figure Description

[0027] The accompanying drawings are provided to further illustrate the present invention and form part of the specification. They are used together with the embodiments of the present invention to explain the present invention, but do not constitute a limitation thereof. In the drawings:

[0028] Figure 1 This is a structural schematic diagram of the present invention (first-person perspective);

[0029] Figure 2 This is a partial structural schematic diagram of the present invention (second perspective).

[0030] Figure 3 This is a schematic diagram of the internal structure of the sterilizer tank (discharge nozzle in the in-process state).

[0031] Figure 4 This is a structural diagram of the discharge gun head (first-person perspective);

[0032] Figure 5 yes Figure 4Enlarged view of the structure at point A in the middle;

[0033] Figure 6 This is a schematic diagram of the discharge gun head (second perspective).

[0034] In the diagram: 1. Laminar flow discharge trolley; 2. Displacement track; 3. Discharge nozzle; 31. Nozzle suction pipe; 32. Transmission rod; 33. Motor; 34. Automatic suction nozzle; 35. Air blow pipe; 36. Crushing wheel; 37. Transmission gear set; 38. Second bevel gear; 39. First bevel gear; 310. Nozzle sterilization chamber door panel; 311. Quick-release port; 4. Freeze dryer raw material tray; 5. Nozzle sterilizer; 51. Sterilizer tank; 52. Pure steam spray pipe; 53. End cap; 54. Pure steam inlet; 55. Automatic door; 56. Door push cylinder; 57. Condensate outlet; 58. Temperature probe interface; 59. Nozzle support; 6. Raw material storage tank; 7. Drive slide rail; 8. Slide seat; 9. Air inlet hose. Detailed Implementation

[0035] The preferred embodiments of the present invention will be 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 the present invention.

[0036] Example:

[0037] like Figures 1-6 As shown, the freeze-dried powder injection feeding and sterilization system includes a displacement track 2 and a laminar flow discharge carriage 1. The laminar flow discharge carriage 1 can move along the displacement track 2, moving back and forth between the freeze dryer outlet and the nozzle sterilizer 5. The laminar flow discharge carriage 1 is equipped with a drive slide rail 7 and a slide block 8. A vacuum feeding nozzle 3 is connected to the slide block 8. The drive slide rail 7 and the slide block 8 work together to move the nozzle 3 in and out of the laminar flow discharge carriage 1, feeding material at the freeze dryer outlet or sterilizing it in conjunction with the nozzle sterilizer 5. The drive slide rail 7 and the slide block 8 can achieve linear movement of the slide block 8 using a conventional structure.

[0038] In the above structure, the laminar flow discharge carriage 1 moves along the displacement track 2, driving the discharge nozzle 3 to the suction station, that is, to the discharge port of the freeze dryer. Figure 1 The middle suction station only shows the freeze dryer raw material tray 4 at the freeze dryer outlet (other structures are not shown). After the cabinet door is connected, the discharge nozzle 3 sucks up material from the freeze dryer raw material tray 4. The freeze-dried powder injection is sent to the raw material storage tank 6 by the discharge nozzle 3 for storage. After the suction operation is completed, the discharge nozzle 3 returns to the laminar flow discharge cart 1. The laminar flow discharge cart 1 drives the discharge nozzle 3 to the sterilization station, that is, the nozzle sterilizer 5, and sends the discharge nozzle 3 into the nozzle sterilizer 5 for sterilization.

[0039] The discharge gun head 3 includes a gun head suction pipe 31, one end of which is connected to an automatic suction gun head 34. A crushing wheel 36 is provided at the suction port of the automatic suction gun head 34. The crushing wheel 36 is connected to a drive mechanism, which can drive the crushing wheel 36 to rotate.

[0040] The crushing wheel 36 can pre-crush the freeze-dried powder injection before it enters the automatic suction head 34, so that the freeze-dried powder injection can quickly enter the automatic suction head 34 and avoid blockage.

[0041] The driving mechanism includes a motor 33. The end of the suction pipe 31 away from the automatic suction gun head 34 is externally connected to the motor 33. The output end of the motor 33 is connected to the transmission rod 32. The end of the transmission rod 32 away from the motor 33 is rotatably connected to the automatic suction gun head 34 and is fixedly connected to a first bevel gear 39. The first bevel gear 39 is meshed with a second bevel gear 38. The second bevel gear 38 is rotatably disposed on one side of the automatic suction gun head 34. The second bevel gear 38 is connected to a transmission gear set 37. The transmission gear set 37 is connected to the crushing wheel 36 and is rotatably disposed on one side of the automatic suction gun head 34.

[0042] In the above structure, the motor 33 drives the transmission rod 32 to rotate, and the transmission rod 32 drives the first bevel gear 39 to rotate. The first bevel gear 39 meshes with the second bevel gear 38, changing the direction of the transmission power, thereby transmitting the power to the transmission gear set 37. The transmission gear set 37 drives the crushing wheel 36 to rotate. The transmission gear set 37 can be equipped with multiple gears for power transmission.

[0043] The crushing wheel 36 includes a central shaft and several crushing teeth. The central shaft is used to connect with the transmission gear set 37.

[0044] Furthermore, an air blowing pipe 35 is provided on the outside of the suction pipe 31 of the gun head. The output end of the air blowing pipe 35 is located close to the automatic suction gun head 34. The air blowing pipe 35 blows nitrogen gas into the suction port of the automatic suction gun head 34, which helps to blow the freeze-dried powder injection crushed by the crushing wheel 36 into the automatic suction gun head 34.

[0045] The sterilizer 5 includes a sterilizer tank 51, which is equipped with a pure steam inlet 54, a pure steam spray pipe 52, and a condensate outlet 57. The pure steam entering through the pure steam inlet 54 is sprayed through the pure steam spray pipe 52 to fully cover the inner and outer walls, effectively ensuring the cleaning effect and heat distribution of the inner and outer walls.

[0046] The sterilizer tank 51 is provided with a cap 53 at one end and an automatic door 55 at the other end. The automatic door 55 is connected to a door-pushing cylinder 56. The sterilizer tank 51 is also provided with a gun head support 59 with several through holes. The gun head support 59 is used to support the discharge gun head 3.

[0047] The nozzle suction pipe 31 is externally fixedly connected to a nozzle sterilization chamber door plate 310, which can cooperate with the automatic door 55 of the nozzle sterilizer 5 to seal the nozzle sterilizer 5. The transmission rod 32 can rotate relative to the nozzle sterilization chamber door plate 310.

[0048] The sterilizer tank 51 is connected to a temperature probe interface 58, which is used to connect a temperature sensor to monitor the internal temperature in real time.

[0049] The sterilizer tank 51 is also connected to an air inlet hose 9, which is connected to nitrogen gas. After sterilization, the sterilizer tank 51 can be purged and dried.

[0050] The end of the suction pipe 31 away from the automatic suction nozzle 34 is provided with a quick-connect port 311, which is connected to the raw material storage tank through a pipe.

Claims

1. A freeze-dried powder injection feeding and sterilization system, characterized in that, Includes a displacement track (2) and a laminar flow discharge cart (1). The laminar flow discharge cart (1) can move along the displacement track (2) and move back and forth between the freeze dryer outlet and the gun head sterilizer (5). The laminar flow discharge cart (1) is equipped with a drive slide rail (7) and a slide seat (8). The discharge gun head (3) is connected to the slide seat (8). The drive slide rail (7) and the slide seat (8) work together to drive the discharge gun head (3) to enter and exit the laminar flow discharge cart (1), cooperate with the freeze dryer outlet to suck up material, or cooperate with the gun head sterilizer (5) to perform sterilization treatment.

2. The freeze-dried powder injection feeding and sterilization system according to claim 1, characterized in that, The discharge gun head (3) includes a gun head suction pipe (31), one end of which is connected to an automatic suction gun head (34). A crushing wheel (36) is provided at the suction port of the automatic suction gun head (34). The crushing wheel (36) is connected to a drive mechanism, which can drive the crushing wheel (36) to rotate.

3. The freeze-dried powder injection feeding and sterilization system according to claim 2, characterized in that, The driving mechanism includes a motor (33), and the end of the suction pipe (31) away from the automatic suction gun head (34) is externally connected to the motor (33). The output end of the motor (33) is connected to the transmission rod (32). The end of the transmission rod (32) away from the motor (33) is rotatably connected to the automatic suction gun head (34) and is fixedly connected to a first bevel gear (39). The first bevel gear (39) is meshed with a second bevel gear (38). The second bevel gear (38) is rotatably disposed on one side of the automatic suction gun head (34). The second bevel gear (38) is connected to a transmission gear set (37). The transmission gear set (37) is connected to the crushing wheel (36). The transmission gear set (37) is rotatably disposed on one side of the automatic suction gun head (34).

4. The freeze-dried powder injection feeding and sterilization system according to claim 2, characterized in that, The crushing wheel (36) includes a central shaft and several crushing teeth.

5. The freeze-dried powder injection feeding and sterilization system according to claim 2, characterized in that, An air blowing pipe (35) is provided on the outside of the suction pipe (31) of the gun head, and the output end of the air blowing pipe (35) is located close to the automatic suction gun head (34).

6. The freeze-dried powder injection feeding and sterilization system according to claim 2, characterized in that, The nozzle sterilizer (5) includes a sterilizer tank (51), which is equipped with a pure steam inlet (54), a pure steam spray pipe (52) and a condensate outlet (57).

7. The freeze-dried powder injection feeding and sterilization system according to claim 6, characterized in that, The sterilizer tank (51) has a cap (53) at one end and an automatic door (55) at the other end. The automatic door (55) is connected to a door-pushing cylinder (56). The sterilizer tank (51) also has a gun head bracket (59) with several through holes.

8. The freeze-dried powder injection feeding and sterilization system according to claim 7, characterized in that, The nozzle suction pipe (31) is fixedly connected to the outside of the nozzle sterilization chamber door plate (310). The nozzle sterilization chamber door plate (310) can cooperate with the automatic door (55) of the nozzle sterilizer (5) to seal the nozzle sterilizer (5).

9. The freeze-dried powder injection feeding and sterilization system according to claim 6, characterized in that, The sterilizer tank (51) is connected to a temperature probe interface (58), and the sterilizer tank (51) is also connected to an air inlet hose (9).

10. The freeze-dried powder injection feeding and sterilization system according to claim 2, characterized in that, The end of the suction pipe (31) away from the automatic suction nozzle (34) is provided with a quick-connect port (311), which is connected to the raw material storage tank through a hose.

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