Filling and cleaning device for sterile environment

Abstract

The invention relates to a filling and cleaning device for a sterile environment, comprising: a filling station for filling a container; the cleaning station is used for cleaning or sterilizing components of the device; the needle head assembly comprises at least one filling needle; the transfer mechanism is used for transferring the needle head assembly between the filling station and the cleaning station; wherein the cleaning station is adjacent to the filling station in the horizontal direction, and the filling station is located at the position higher than the cleaning station in the vertical direction. According to the filling and cleaning device for the sterile environment, the filling station and the cleaning station are arranged at a close distance in the horizontal direction, meanwhile, the filling station is higher than the cleaning station in the vertical direction, cross contamination of the cleaning station to the filling station is blocked through the gravity effect, and the filling efficiency is improved. Due to the fact that the station distance is short, the movement stroke of the transfer mechanism is reduced, the mechanical stress borne by a pipeline connected to the needle head assembly is reduced, and the reliability of equipment is improved.

Description

Technical Field

[0001] The present application relates to the technical field of pharmaceutical equipment, and in particular to a filling and cleaning device for use in a sterile environment. Background Art

[0002] In the current production process of sterile injectables, to ensure product sterility and safety and avoid cross-contamination between batches, the filling equipment used must have online cleaning (CIP) and online sterilization (SIP) functions. This means that after completing a production batch, the filling needle assembly used to fill the drug solution must be able to automatically move from the filling station where it was performing the filling task to a dedicated cleaning / sterilization station to complete the cleaning and disinfection process and prepare for the next batch of production.

[0003] Currently, the industry's common approach to achieving this goal is to place the cleaning and filling stations at a considerable distance. However, this design requires the transfer mechanism to have a large travel range, resulting in significant bending and torsional stresses in the tubing connected to the needle assembly (typically rigid or semi-rigid tubes used to transport medication, cleaning fluids, steam, etc.). This repeated, drastic deformation can easily lead to tubing fatigue, loose connections, and even leakage, severely impacting the equipment's reliability and service life, and posing a potential risk of contamination. Furthermore, the long-stroke transfer mechanism itself is complex and bulky, occupying valuable clean space within sterile isolators or restricted-access barrier systems.

[0004] Another approach to overcome the drawbacks of the aforementioned long-stroke solution is to use linear motion mechanisms such as linear guides and ball screws to transfer the needle assembly. While this approach shortens the stroke, friction between the rolling or sliding components of the linear sliding mechanism during motion inevitably generates metal or non-metallic particles, a serious source of contamination that is absolutely unacceptable in a clean environment. Furthermore, to protect these moving parts, a flexible cover such as a bellows is typically required for sealing. However, the bellows' pleated structure creates numerous blind spots during cleaning and sterilization, making them difficult to clean thoroughly. Furthermore, the bellows themselves are susceptible to fatigue and breakage, compromising the integrity of the sterile environment. Summary of the Invention

[0005] In order to solve the above problems, the present application provides a filling and cleaning device for use in a sterile environment, which avoids cross contamination while reducing the mechanical stress of the filling pipeline.

[0006] In order to achieve the above-mentioned purpose, the filling and cleaning device for a sterile environment designed in the present application includes: a filling station for filling containers; a cleaning station for cleaning or sterilizing components of the device; a needle assembly including at least one filling needle; and a transfer mechanism configured to transfer the needle assembly between the filling station and the cleaning station; wherein the cleaning station is arranged adjacent to the filling station in the horizontal direction, and the filling station is located at a position higher than the cleaning station in the vertical direction.

[0007] Preferably, the transfer mechanism includes a lifting mechanism, a base, a posture synchronization mechanism and a main rotating arm that swings around the axis of the base. The base is vertically lifted and lowered under the drive of the lifting mechanism, and the needle assembly is installed at the end of the main rotating arm; the posture synchronization mechanism is used to keep the filling needles of the needle assembly in a preset vertical posture when the main rotating arm swings.

[0008] Preferably, the posture synchronization mechanism includes: a driving wheel, which is coaxially arranged at the axis of the base and fixed relative to the base; a driven wheel, which is coaxially arranged at the installation position of the needle assembly; and a flexible transmission member connecting the driving wheel and the driven wheel.

[0009] Preferably, the flexible transmission member is a synchronous belt, and the driving wheel and the driven wheel are synchronous pulleys with the same transmission ratio.

[0010] Preferably, the posture synchronization mechanism further includes a tensioning wheel, and the tensioning wheel is used to apply tensioning force to the synchronous belt.

[0011] Preferably, an installation space is formed in the internal hollow of the main rotating arm, and the driving wheel, driven wheel and flexible transmission member are all accommodated in the installation space; the driven wheel has an axially horizontally extending connecting shaft, and the connecting shaft has an exposed portion extending out of the installation space, and the needle assembly is detachably mounted on the exposed portion through an assembly seat.

[0012] Preferably, an annular shielding cover is provided on the side wall of the main rotating arm facing the assembly seat, the annular shielding cover is arranged around the circumference of the exposed part, and an annular elastic lip is provided on one end of the annular shielding cover away from the main rotating arm and in contact with the assembly seat.

[0013] Preferably, the assembly seat includes a first branch and a second branch arranged at an angle to the first branch, the exposed portion is fixedly mounted on the first branch by an axial locking screw, and the first branch is provided with a first cover body covering the axial locking screw; the needle assembly is detachably mounted on the second branch by a hand screw.

[0014] Preferably, the lifting mechanism has a vertically lifting bearing platform, and the base is fixedly mounted on the bearing platform; a driving motor is provided on the bearing platform, and the driving motor is connected to the main rotating arm through a transmission mechanism.

[0015] Preferably, the transmission mechanism includes a first bevel tooth arranged on the base and a second bevel tooth meshing with the first bevel tooth, and a second cover covering the first bevel tooth and the second bevel tooth; the first bevel tooth is connected to the main rotating arm, and the base is mounted on the supporting platform through a hollow support tube, and a transmission rod is vertically arranged in the support tube, one end of the transmission rod extends into the second cover and is connected to the second bevel tooth, and the other end is connected to the output shaft of the drive motor.

[0016] The filling and cleaning device designed for a sterile environment, designed in this application, utilizes gravity to prevent cross-contamination of the filling station from the cleaning station by locating the filling and cleaning stations horizontally close together and vertically positioning the filling station higher than the cleaning station. The close proximity of the stations also reduces the travel of the transfer mechanism, reducing the mechanical stress on the tubing connected to the needle assembly and improving the reliability of the device. Furthermore, the use of a rotary transfer mechanism for station switching avoids the problem of particulate contamination caused by friction in traditional linear sliding mechanisms, ensuring the cleanliness of the sterile environment. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 This is a filling and cleaning device for a sterile environment provided in an embodiment of the present application.

[0018] Figure 2 It is a structural schematic diagram of a filling and cleaning device for a sterile environment provided in an embodiment of the present application.

[0019] Figure 3 It is a three-dimensional exploded view of the posture synchronization mechanism provided in an embodiment of the present application.

[0020] Figure 4 It is a schematic diagram of the planar structure of the transfer mechanism provided in an embodiment of the present application.

[0021] Figure 5 yes Figure 3 Cross-sectional view at AA in the middle.

[0022] Figure 6 yes Figure 3 Cross-sectional view at the middle BB.

[0023] Among them: filling station 10, cleaning station 20, needle assembly 30, filling needle 31, transfer mechanism 40, lifting mechanism 41, bearing platform 411, drive motor 412, support cylinder 413, base 42, posture synchronization mechanism 43, driving wheel 431, driven wheel 432, connecting shaft 4321, exposed part 4322, flexible transmission part 433, tensioning wheel 434, main rotating arm 44, installation space 441, assembly seat 50, first branch 51, second branch 52, shaft locking screw 53, first cover body 54, hand screw 55, annular shielding cover 60, annular elastic lip 61, transmission mechanism 70, first bevel gear 71, second bevel gear 72, second cover body 73, transmission rod 74, pipe rack 80. DETAILED DESCRIPTION

[0024] The preferred embodiments of the present application are described below in conjunction with the accompanying drawings. It should be understood that the preferred embodiments described herein are only used to illustrate and explain the present application and are not used to limit the present application.

[0025] like Figures 1 to 6 As shown, the filling and cleaning device for a sterile environment described in this embodiment mainly includes a filling station 10 , a cleaning station 20 , a needle assembly 30 and a transfer mechanism 40 for transferring the needle assembly 30 .

[0026] In this embodiment, the filling station 10 is a designated operating area for sterile liquid filling of specific containers, such as vials and cartridges. The cleaning station 20 is a designated operating area for performing cleaning-in-place (CIP) or sterilization-in-place (SIP) on the needle assembly 30. The needle assembly 30 includes a needle holder and at least one filling needle 31 mounted on the holder for fluid delivery. The specific number of filling needles 31 is determined based on actual needs and is not specifically limited here.

[0027] The cleaning station 20 is horizontally adjacent to the filling station 10. For example, the horizontal distance between the center points of the two stations can be controlled within 300 mm, preferably between 100-200 mm. Furthermore, the filling station 10 is vertically located above the cleaning station 20. This height difference makes it difficult for waste liquid, condensed water, or splashing droplets generated by the filling needle 31 during cleaning or sterilization in the cleaning station 20 to overcome gravity and upwardly contaminate the clean filling station 10, thereby forming an effective physical contamination barrier.

[0028] At the same time, if Figure 1As shown, the transfer mechanism 40 is disposed beside the filling station 10 and the cleaning station 20 and is configured to transfer the needle assembly 30 between the filling station 10 and the cleaning station 20. During operation, illustratively, the transfer mechanism 40 drives the needle assembly 30 to first be positioned at the higher filling station 10, where it performs the filling task on the containers transferred there. After a batch of filling tasks is completed, the transfer mechanism 40 again drives the needle assembly 30 to move down from the filling station 10 to the lower cleaning station 20, where the needle assembly 30 undergoes an in-line cleaning or sterilization process.

[0029] In specific implementation, the device is usually installed inside a sterile isolator with internal positive pressure or a restricted access barrier system. With the above structural design, since the horizontal distance between the filling station 10 and the cleaning station 20 is very close, the movement stroke of the transfer mechanism 40 is effectively shortened, which makes the bending and torsional stresses borne by the filling liquid supply pipeline (not shown) connected to each filling needle 31 on the needle assembly 30 effectively minimized. After the cleaning and sterilization process is completed, the transfer mechanism 40 lifts and transfers the needle assembly 30 back to the filling station 10, ready to perform the next filling task. In this way, this embodiment does not need to adopt a linear sliding mechanism that is easy to generate dust, and also avoids the pipeline stress problem caused by long-distance transfer, taking into account the multiple needs of preventing cross contamination, ensuring mechanical cleanliness and improving equipment reliability. In this embodiment, if Figure 1 As shown, a tube rack 80 is also provided on the needle assembly 30 for fixing the infusion tubes connected to each filling needle 31.

[0030] In some embodiments, as Figure 1 、 Figure 2 、 Figure 3 As shown, the transfer mechanism 40 includes a lifting mechanism 41, a base 42, a posture synchronization mechanism 43 and a main rotating arm 44. Specifically, the lifting mechanism 41 serves as the vertical motion unit of the entire transfer mechanism 40, and can drive the components carried thereon to achieve vertical lifting and lowering as a whole. The base 42 is fixedly mounted on the lifting mechanism 41 and is vertically lifted and lowered accordingly. One end of the main rotating arm 44 is pivotally connected to the base 42 in a rotatable manner and can swing around a central axis of the base 42 at a predetermined angle. The needle assembly 30 is mounted on the other end of the main rotating arm 44, i.e., the end. By coordinating the lifting and lowering movement of the lifting mechanism 41 with the swinging movement of the main rotating arm 44, the needle assembly 30 can be precisely displaced from the filling station 10 to the cleaning station 20 in three-dimensional space.

[0031] In this embodiment, the posture synchronization mechanism 43 is used to maintain the predetermined vertical posture of each filling needle 31 of the needle assembly 30 when the main rotating arm 44 swings. That is, when the main rotating arm 44 swings to any target angle, the posture synchronization mechanism 43 ensures that the needle assembly 30 always maintains its initial posture. In this embodiment, the posture synchronization mechanism 43 keeps the filling needle 31 vertically downward, which facilitates filling, cleaning and sterilization.

[0032] In some embodiments, as Figure 2 As shown, the posture synchronization mechanism 43 includes a driving wheel 431, a driven wheel 432, and a flexible transmission member 433. The driving wheel 431 is coaxially disposed on the axis of the base 42 and fixed relative to the base 42; the driven wheel 432 is coaxially disposed at the mounting location of the needle assembly 30; and the flexible transmission member 433 connects the driving wheel 431 and the driven wheel 432. In a specific embodiment, the flexible transmission member 433 is a synchronous belt, and the driving wheel 431 and the driven wheel 432 are synchronous pulleys with the same transmission ratio, that is, they have the same number of teeth.

[0033] With this structural design, when the main rotating arm 44 swings clockwise around the axis of the base 42 through an angle θ, since the driving wheel 431 is fixed, this swing forces the flexible transmission member 433, or the timing belt, to shift, thereby driving the driven wheel 432 to rotate in an equal and opposite direction relative to the main rotating arm 44, i.e., counterclockwise through an angle θ. This compensating rotation offsets the attitude change caused by the swing of the main rotating arm 44, thereby ensuring that the angular displacement of the needle assembly 30 relative to a fixed reference frame, such as the base 42 or the ground, is always zero, thus achieving a constant attitude.

[0034] Furthermore, in order to ensure the transmission accuracy and prevent the synchronous belt from loosening or jumping teeth during operation, Figure 2 As shown, the posture synchronization mechanism 43 also includes a tensioning wheel 434. Specifically, the tensioning wheel 434 is arranged between the driving wheel 431 and the driven wheel 432, and is pressed against the outer side of the synchronous belt to provide it with continuous and appropriate tension, ensuring the stability and reliability of the entire synchronization system.

[0035] In some embodiments, as Figure 2 As shown, the main rotating arm 44 is hollowed out to form an installation space 441, and the driving wheel 431, the driven wheel 432, and the flexible transmission member 433 are all accommodated in the installation space 441. This isolates the moving parts from the external sterile environment, effectively protecting the internal mechanism from external cleaning agents or moisture, and fundamentally eliminating the risk of particles generated by the moving mechanism leaking into the external environment.

[0036] At the same time, if Figure 2 、 Figure 5、 Figure 6 As shown, the driven wheel 432 has an axially horizontally extending connecting shaft 4321, and the connecting shaft 4321 has an exposed portion 4322 extending out of the installation space 441. The needle assembly 30 is detachably mounted on the exposed portion 4322 via an assembly seat 50. This facilitates the replacement and disassembly of needle assemblies 30 of different specifications for cleaning. In some embodiments, as Figure 2 、 Figure 6 As shown, an annular shielding cover 60 is provided on the side wall of the main rotating arm 44 facing the assembly seat 50. The annular shielding cover 60 is arranged around the circumference of the exposed portion 4322, and an annular elastic lip 61 is provided on the end of the annular shielding cover 60 facing away from the main rotating arm 44, which contacts the assembly seat 50. The elastic lip 61 forms a slight, flexible contact with the surface of the assembly seat 50, forming an effective physical seal to further avoid the risk of particles that may be generated by the moving parts themselves leaking into the external environment. In addition, when the equipment is being cleaned externally, this annular elastic lip 61 can effectively prevent cleaning liquid or impurities from invading the rotating gap and the interior of the equipment.

[0037] In some embodiments, as Figure 1 、 Figure 2 As shown, the assembly base 50 is generally L-shaped, comprising a first branch 51 and a second branch 52 arranged at an angle to the first branch 51. The exposed portion 4322 is fixedly mounted to the first branch 51 via a locking screw 53 to ensure rigidity and precision in power transmission. Furthermore, a first cover 54 is provided on the first branch 51 to cover the locking screw 53, eliminating blind spots during cleaning and preventing possible particle leakage. The needle assembly 30 is removably mounted to the second branch 52 via a thumb screw 55. This allows the operator to quickly replace the needle assembly 30 without any tools, significantly improving production efficiency and ease of use.

[0038] In some embodiments, as Figure 1 、 Figure 3 、 Figure 4 As shown, the lifting mechanism 41 has a vertically lifting support platform 411, and the base 42 is fixedly mounted on the support platform 411; a driving motor 412 is provided on the support platform 411, and the driving motor 412 is connected to the main rotating arm 44 through a transmission mechanism 70, so as to ultimately drive the main rotating arm 44 to swing around the axis of the base 42.

[0039] When implementing it specifically, Figure 1 、 Figure 3 、 Figure 4As shown, the base 42 is mounted on the support platform 411 through a hollow support tube 413 to form a stable support. The transmission mechanism 70 includes a first bevel tooth 71 provided on the base 42 and a second bevel tooth 72 meshing with the first bevel tooth 71. The first bevel tooth 71 is connected to the main rotating arm 44, and its rotation will directly drive the main rotating arm 44 to swing. A transmission rod 74 is vertically arranged in the support tube 413. One end of the transmission rod 74 extends into the second cover body 73 and is connected to the second bevel tooth 72, and the other end is connected to the output shaft of the drive motor 412 to form a complete power transmission path. In addition, the transmission mechanism 70 also includes a second cover body 73 covering the first bevel tooth 71 and the second bevel tooth 72. This is to isolate the gear meshing area from the external environment and prevent lubricant leakage or wear particles from leaking out. In this way, the moving parts can be isolated by the support tube 413 and the second cover body 73, and the base 42 is installed on the supporting platform 411 through the support tube 413, so that the lifting mechanism 41 can be set in the working area away from the filling needle 31 to avoid contamination.

[0040] The filling and cleaning device for a sterile environment provided in the embodiments of the present application utilizes gravity to prevent cross-contamination of the filling station from the cleaning station by locating the filling and cleaning stations horizontally close together and vertically positioning the filling station higher than the cleaning station. The close proximity of the stations also reduces the travel of the transfer mechanism, reducing the mechanical stress on the tubing connected to the needle assembly and improving the reliability of the device. Furthermore, the use of a rotary motion-based transfer mechanism for station switching avoids the problem of particulate contamination caused by friction in traditional linear sliding mechanisms, ensuring the cleanliness of the sterile environment.

[0041] In the description of this application, it should be noted that the terms "vertical", "up", "down", "horizontal", etc. indicate orientations or positional relationships based on the orientations or positional relationships 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, be constructed and operated in a specific orientation. Therefore, they cannot be understood as limitations on this application.

[0042] It should also be noted that, in the description of this application, unless otherwise expressly specified or limited, the terms "disposed," "installed," "connected," and "connected" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on specific circumstances.

[0043] Finally, it should be noted that the above description is merely a preferred embodiment of the present application and is not intended to limit the present application. Although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art may still modify the technical solutions described in the aforementioned embodiments or substitute equivalents for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application shall be included within the scope of protection of the present application.

Claims

1. A filling and cleaning device for a sterile environment, characterized in that: include: Filling station, used for filling containers; a cleaning station for cleaning or sterilizing components of the device; a needle assembly comprising at least one filling needle; A transfer mechanism is configured to transfer the needle assembly between the filling station and the cleaning station; wherein the cleaning station is arranged adjacent to the filling station in the horizontal direction, and the filling station is located at a position higher than the cleaning station in the vertical direction.

2. The filling and cleaning device for a sterile environment according to claim 1, characterized in that: The transfer mechanism includes a lifting mechanism, a base, a posture synchronization mechanism and a main rotating arm that swings around the axis of the base. The base is vertically lifted and lowered under the drive of the lifting mechanism, and the needle assembly is installed at the end of the main rotating arm; the posture synchronization mechanism is used to keep the filling needles of the needle assembly in a preset vertical posture when the main rotating arm swings.

3. The filling and cleaning device for a sterile environment according to claim 2, characterized in that: The posture synchronization mechanism includes: a driving wheel, which is coaxially arranged at the axis of the base and fixed relative to the base; a driven wheel, which is coaxially arranged at the installation position of the needle assembly; and a flexible transmission member connecting the driving wheel and the driven wheel.

4. The filling and cleaning device for a sterile environment according to claim 3, characterized in that: The flexible transmission member is a synchronous belt, and the driving wheel and the driven wheel are synchronous pulleys with the same transmission ratio.

5. The filling and cleaning device for a sterile environment according to claim 4, characterized in that: The posture synchronization mechanism further includes a tensioning wheel, and the tensioning wheel is used to apply tensioning force to the synchronous belt.

6. The filling and cleaning device for a sterile environment according to claim 3, characterized in that: The internal hollow space of the main rotating arm forms an installation space, and the driving wheel, driven wheel and flexible transmission member are all accommodated in the installation space; the driven wheel has an axially horizontally extending connecting shaft, and the connecting shaft has an exposed portion extending out of the installation space, and the needle assembly is detachably mounted on the exposed portion through an assembly seat.

7. The filling and cleaning device for a sterile environment according to claim 6, characterized in that: An annular shielding cover is provided on the side wall of the main rotating arm facing the assembly seat. The annular shielding cover is arranged around the circumference of the exposed part, and an annular elastic lip is provided on one end of the annular shielding cover away from the main rotating arm and in contact with the assembly seat.

8. The filling and cleaning device for a sterile environment according to claim 6, characterized in that: The assembly seat includes a first branch and a second branch arranged at an angle to the first branch. The exposed portion is fixedly mounted on the first branch by an axial locking screw, and a first cover body covering the axial locking screw is provided on the first branch; the needle assembly is detachably mounted on the second branch by a hand screw.

9. The filling and cleaning device for a sterile environment according to claim 2, characterized in that: The lifting mechanism has a vertically lifting bearing platform, and the base is fixedly mounted on the bearing platform; a driving motor is provided on the bearing platform, and the driving motor is connected to the main rotating arm through a transmission mechanism.

10. The filling and cleaning device for a sterile environment according to claim 9, characterized in that: The transmission mechanism includes a first bevel tooth arranged on the base and a second bevel tooth meshing with the first bevel tooth, and a second cover body covering the first bevel tooth and the second bevel tooth; the first bevel tooth is connected to the main rotating arm, and the base is mounted on the supporting platform through a hollow support tube, and a transmission rod is vertically arranged in the support tube, one end of the transmission rod extends into the second cover body and is connected to the second bevel tooth, and the other end is connected to the output shaft of the drive motor.

Images