A cleaning system and method for negative pressure filling and capping equipment

Abstract

This application discloses a cleaning system and method for negative pressure filling and capping equipment, relating to the field of pharmaceutical preparation production technology. The cleaning system for negative pressure filling and capping equipment includes a cleaning fluid supply unit, a positive pressure drive unit, and a cleaning cup. The cleaning fluid supply unit supplies cleaning fluid, and the positive pressure drive unit delivers the cleaning fluid into the upper storage tank and foam recovery tank of the negative pressure filling and capping equipment. A cleaning chamber is formed inside the cleaning cup. The cleaning system and method for negative pressure filling and capping equipment of this application can perform in-situ cleaning of the equipment, improving cleaning efficiency and avoiding secondary contamination.

Description

Technical Field

[0001] This application relates to the field of pharmaceutical preparation production technology, and in particular to a cleaning system and cleaning method for negative pressure filling and capping equipment. Background Technology

[0002] In pharmaceutical manufacturing, negative pressure filling and capping equipment is a key piece of equipment. Its filling system (including upper / lower reservoirs, filling needles, connecting hoses, drug pipelines, etc.) must be thoroughly and reliably cleaned and disinfected after production to prevent cross-contamination and ensure drug quality.

[0003] In current technology, the conventional cleaning method involves operators disassembling all components of the negative pressure filling and capping equipment that come into contact with the medication after production. These components include, but are not limited to, the upper and lower storage tanks, vacuum tubes, filling needles, and medication pipelines. The disassembled components are then manually transferred to a cleaning room for rinsing, alkali soaking, and disinfection, typically supplemented by sterilization and drying in a separate pulsed vacuum sterilizer. After all components are sterilized and dried, they are manually transported back to the filling room for reassembly, connection, and testing. This process constitutes a complete cleaning and disinfection cycle.

[0004] While the above cleaning methods can achieve the cleaning purpose, they have the following problems: 1. Low operational efficiency and high labor costs. The entire process of disassembly, transportation, cleaning, sterilization, reassembly, and debugging is complicated and requires a large amount of manual intervention and time consumption. Completing a complete cleaning and disinfection cycle usually takes about 4 hours, which seriously limits the production availability of the equipment and becomes a bottleneck for improving production efficiency; 2. High risk of secondary contamination and foreign object introduction. Components are easily contaminated during multiple transportations, exposures, manual cleaning, and reassembly after disassembly, introducing difficult-to-detect secondary contaminants and foreign objects, posing a serious challenge to product quality; 3. Severe mechanical wear of equipment components. Frequent physical disassembly and installation, especially of precision filling needles, sealing interfaces, and hose connectors, will cause mechanical wear, aging of seals, and stripping of threads, directly affecting the long-term operational stability, filling accuracy, and service life of the equipment, and increasing maintenance costs. Summary of the Invention

[0005] The purpose of this application is to provide a cleaning system and method for negative pressure filling and capping equipment, which can achieve in-situ, sealed, and automated cleaning of parts that come into contact with liquid medicine.

[0006] To achieve the above objectives, this application provides a cleaning system for a negative pressure filling and capping equipment, comprising: a cleaning fluid supply unit, a positive pressure drive unit, and a cleaning cup;

[0007] The cleaning fluid supply unit is used to supply cleaning fluid;

[0008] The positive pressure drive unit is used to send the cleaning fluid into the upper storage tank and foam recovery tank of the negative pressure filling and capping equipment.

[0009] The cleaning cup can be sealed with the filling needle of the negative pressure filling and capping equipment. A cleaning chamber can be formed inside the cleaning cup. The filling needle has an inner channel and an outer channel. One end of the inner channel is connected to the upper liquid storage tank through a vacuum tube, and the other end is connected to the cleaning chamber. The filling needle is provided with a reflux interface. One end of the outer channel is connected to the reflux interface, and the other end is connected to the cleaning chamber. The reflux interface is connected to the lower liquid storage tank of the negative pressure filling and capping equipment through a medicine hose. Both the foam recovery tank and the lower liquid storage tank are provided with drain ports.

[0010] In some embodiments, a sealing ring is provided at the mouth of the cleaning cup, the sealing ring being used to seal with the filling needle.

[0011] In some embodiments, the outer wall of the injection needle is provided with a relief groove, which is flush with the sealing ring to avoid direct contact between the outer wall of the injection needle and the sealing ring.

[0012] In some embodiments, a drying unit is also provided, which is capable of introducing clean compressed air into the upper liquid storage tank and the foam recovery tank.

[0013] In some embodiments, an emission monitoring unit is also provided, which is installed at each of the two discharge ports to detect the discharged wastewater.

[0014] In some embodiments, both the cleaning fluid supply unit and the drying unit are equipped with electrically controlled valves at their input terminals.

[0015] In some embodiments, the upper liquid storage tank and the lower liquid storage tank are connected by a return pipe, and the return pipe is equipped with a control valve.

[0016] A cleaning method for a negative pressure filling and capping equipment, applied to the cleaning system for negative pressure filling and capping equipment described in any one of the above-mentioned methods, includes the following steps:

[0017] Open the electronically controlled valve at the cleaning fluid supply unit, start the positive pressure drive unit, and discharge the cleaning fluid into the upper storage tank and foam recovery tank. The cleaning fluid in the upper storage tank enters the filling needle through the vacuum tube, then enters the cleaning cup through the inner channel of the filling needle, and enters the lower storage tank through the outer channel of the filling needle and the medicine hose. The cleaning fluid in the lower storage tank and foam recovery tank is discharged through the drain port.

[0018] The discharged cleaning fluid is tested by the emission monitoring unit. Once the discharged cleaning fluid meets the requirements, the electrically controlled valve and positive pressure drive unit between the cleaning fluid supply unit and the upper storage tank are closed.

[0019] In some embodiments, after the discharged cleaning fluid meets the requirements and the electrically controlled valve and positive pressure drive unit between the cleaning fluid supply unit and the upper storage tank are closed, the method further includes: closing the drain ports of the lower storage tank and the foam recovery tank, replacing the cleaning fluid in the cleaning fluid supply unit with disinfectant, opening the electrically controlled valve at the cleaning fluid supply unit, starting the positive pressure drive unit, discharging the disinfectant into the upper storage tank and the foam recovery tank, closing the positive pressure drive unit after the liquid level in the lower storage tank reaches the set requirements, soaking for a set time, opening the drain ports of the lower storage tank and the foam recovery tank, and rinsing with purified water until the pH value of the discharged fluid is neutral.

[0020] In some embodiments, after rinsing with purified water until the pH of the effluent is neutral, the process further includes: opening the electrically controlled valve at the drying unit and introducing clean compressed air for purging and drying.

[0021] Compared to the aforementioned background technology, the cleaning system for a negative pressure filling and capping device provided in this application includes a cleaning fluid supply unit, a positive pressure drive unit, and a cleaning cup. The cleaning fluid supply unit is used to supply cleaning fluid, and the positive pressure drive unit is used to send the cleaning fluid into the upper storage tank and the foam recovery tank of the negative pressure filling and capping device. A cleaning chamber can be formed inside the cleaning cup. The filling needle has an inner channel and an outer channel. One end of the inner channel is connected to the upper storage tank through a vacuum tube, and the other end is connected to the cleaning chamber. The filling needle is provided with a return port. One end of the outer channel is connected to the return port, and the other end is connected to the cleaning chamber. The return port is connected to the lower storage tank of the negative pressure filling and capping device through a medicine hose. Both the foam recovery tank and the lower storage tank are provided with drain ports. The positive pressure drive unit pumps the cleaning fluid from the cleaning fluid supply unit into the upper storage tank and the foam recovery tank. The cleaning fluid in the upper storage tank enters the inner channel of the filling needle through the vacuum tube and is then fed into the cleaning cup. The cleaning fluid in the cleaning cup rinses the outer wall of the filling needle. The cleaning fluid in the cleaning cup can then flow from the outer channel of the filling needle along the drug pipeline into the lower storage tank. The cleaning fluid in the lower storage tank and the foam recovery tank can be discharged through their respective drain ports. During the flow of the cleaning fluid, the inner walls of each component are rinsed. After cleaning, the cleaning fluid in the cleaning fluid supply unit is replaced with disinfectant. The positive pressure drive unit pumps the disinfectant into the pipeline system. After soaking for a set time, the disinfectant is discharged, and purified water is introduced into the pipeline until the pH of the discharged liquid is neutral, thus achieving disinfection. The cleaning system and method for negative pressure filling and capping equipment disclosed in this application enable in-situ cleaning and disinfection of the equipment. Compared with manual disassembly and cleaning, this method shortens the cleaning time, thereby increasing the equipment's uptime and improving production efficiency. The cleaning process takes place in situ, and the cleaning system is a closed pipeline, avoiding the risk of secondary microbial contamination and foreign object introduction caused by component disassembly, transportation, and manual handling. It also avoids physical and mechanical wear and fatigue damage to the precision structure of the filling needle, pipeline joints, and seals caused by frequent disassembly, resulting in a reduction in overall maintenance costs. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this application. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0023] Figure 1 This is a schematic diagram of a cleaning system for a negative pressure filling and capping device according to an embodiment of this application.

[0024] in:

[0025] 100. Upper reservoir; 200. Filling needle; 300. Lower reservoir; 400. Vacuum suction tube; 500. Medicine tubing; 600. Foam recovery tank;

[0026] 1. Cleaning fluid supply unit; 2. Cleaning cup; 3. Sealing ring; 4. Drying unit. Detailed Implementation

[0027] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0028] To enable those skilled in the art to better understand the present application, the present application will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0029] It should be noted that the directional terms such as "upper end," "lower end," "left side," and "right side" mentioned below are defined based on the accompanying drawings in the instruction manual.

[0030] like Figure 1 As shown in the embodiment of this application, the cleaning system for a negative pressure filling and capping device includes a cleaning fluid supply unit 1, a positive pressure drive unit, and a cleaning cup 2. The cleaning fluid supply unit 1 is used to supply cleaning fluid, and the positive pressure drive unit is used to send the cleaning fluid into the upper storage tank 100 and the foam recovery tank 600 of the negative pressure filling and capping device. A cleaning chamber can be formed inside the cleaning cup 2. The filling needle 200 has an inner channel and an outer channel. One end of the inner channel is connected to the upper storage tank 100 through a vacuum tube 400, and the other end is connected to the cleaning chamber. The filling needle 200 is provided with a return port. One end of the outer channel is connected to the return port, and the other end is connected to the cleaning chamber. The return port is connected to the lower storage tank 300 of the negative pressure filling and capping device through a medicine hose 500. Both the foam recovery tank 600 and the lower storage tank 300 are provided with drain ports.

[0031] Specifically, the cleaning fluid supply unit 1 can be a storage tank containing cleaning fluid. The cleaning fluid supply unit 1 is connected to the upper storage tank 100 and the foam recovery tank 600 of the negative pressure filling and capping equipment via pipelines. The positive pressure drive unit can be a clean centrifugal pump, which pumps the liquid in the cleaning fluid supply unit 1 into the upper storage tank 100 and the foam recovery tank 600. The upper storage tank 100 is connected to the inner channel of the filling needle 200 via a vacuum tube 400. The filling needle 200 extends into the cleaning cup. The cleaning cup 2 can be sealed with the filling needle 200 of the negative pressure filling and capping equipment, thereby isolating the outlet of the filling needle 200 from the outside. The outer channel of the filling needle 200 is connected to the lower storage tank 300 via a liquid pipeline. The entire pipeline system is a closed system.

[0032] Understandably, the positive pressure drive unit pumps the cleaning fluid from the cleaning fluid supply unit 1 into the upper storage tank 100 and the foam recovery tank 600. The cleaning fluid in the upper storage tank 100 enters the inner channel of the filling needle 200 through the vacuum tube 400 and is fed into the cleaning cup. The cleaning fluid in the cleaning cup rinses the outer wall of the filling needle 200. The cleaning fluid in the cleaning cup can enter the lower storage tank 300 from the outer channel of the filling needle 200 along the drug pipeline. The cleaning fluid in the lower storage tank 300 and the foam recovery tank 600 can be discharged through the corresponding drain ports. During the flow, the cleaning fluid rinses the inner walls of each component. After cleaning, the cleaning fluid in the cleaning fluid supply unit 1 is replaced with disinfectant. The positive pressure drive unit pumps the disinfectant into the pipeline system. After soaking for a set time, the disinfectant is discharged, and purified water is introduced into the pipeline until the pH of the discharged liquid is neutral, thus achieving disinfection.

[0033] The cleaning system for negative pressure filling and capping equipment disclosed in this application enables in-situ cleaning and disinfection of the equipment. Compared with manual disassembly and cleaning, it shortens the cleaning time, thereby increasing the equipment's uptime and improving production efficiency. The cleaning process takes place in situ, and the cleaning system is a closed pipeline, avoiding the risk of secondary microbial contamination and foreign object introduction caused by component disassembly, transportation, and manual handling. At the same time, it avoids physical and mechanical wear and fatigue damage to the precision structure of the filling needle 200, pipeline joints, and seals caused by frequent disassembly, thus reducing overall maintenance costs.

[0034] In some embodiments, a sealing ring 3 is provided at the mouth of the cleaning cup 2, which is used to seal with the filling needle 200.

[0035] Specifically, a sealing fit is formed between the sealing ring 3 and the outer wall of the filling needle 200.

[0036] Understandably, the sealing ring 3 further ensures that the outlet of the filling needle 200 is isolated from the atmospheric environment to avoid contamination of the filling needle 200.

[0037] Based on the above embodiments, the outer wall of the filling needle 200 is provided with a relief groove, which is flush with the sealing ring 3 to avoid direct contact between the outer wall of the filling needle 200 and the sealing ring 3.

[0038] It is understandable that by setting the clearance groove, the outer wall of the filling needle 200 is prevented from directly contacting the sealing ring 3, thereby preventing the sealing ring 3 from contaminating the outer wall of the filling needle 200.

[0039] In some embodiments, a drying unit 4 is also provided, which can introduce clean compressed air into the upper liquid storage tank 100 and the foam recovery tank 600.

[0040] It is understood that the drying unit 4 can be a blower. The drying unit 4 introduces clean compressed air through the upward liquid storage tank 100 and the foam recovery tank 600. When the compressed air flows in the pipeline system, it can purge and dry the pipeline and equipment.

[0041] Specifically, the input pipelines of the upper liquid storage tank 100 and the foam recovery tank 600 are provided with two input ends. Both input ends are equipped with tees and valves, and are connected to the cleaning fluid supply unit 1 and the drying unit 4. The input of cleaning water, disinfectant and clean compressed air can be switched through the valves.

[0042] In some embodiments, an emission monitoring unit is also provided, which is installed at each of the two discharge ports to detect the discharged wastewater.

[0043] Specifically, the emission monitoring unit can be a conductivity meter.

[0044] Understandably, the cleaning effect can be identified by monitoring the conductivity of the drain outlet. The cleaning process can be terminated when the conductivity of the discharged liquid reaches the set range.

[0045] In some embodiments, both the input terminals of the cleaning fluid supply unit 1 and the drying unit 4 are equipped with electrically controlled valves.

[0046] Understandably, using electrically controlled valves can reduce manual operation and improve cleaning efficiency.

[0047] In some embodiments, the upper liquid storage tank 100 and the lower liquid storage tank 300 are connected by a return pipe, and the return pipe is equipped with a control valve.

[0048] The cleaning method for negative pressure filling and capping equipment of this application, applied to the cleaning system for negative pressure filling and capping equipment in the above embodiments, includes the following steps:

[0049] First, open the electrically controlled valve at the cleaning fluid supply unit 1, close the control valve of the return pipe between the upper storage tank 100 and the lower storage tank 300, start the positive pressure drive unit, and discharge the cleaning fluid into the upper storage tank 100 and the foam recovery tank 600. The cleaning fluid in the upper storage tank 100 enters the filling needle 200 through the vacuum suction tube 400, then enters the cleaning cup through the inner channel of the filling needle 200, and enters the lower storage tank 300 through the outer channel of the filling needle 200 and the medicine hose 500. The cleaning fluid in the lower storage tank 300 and the foam recovery tank 600 is discharged through the drain port.

[0050] The second step is to test the discharged cleaning fluid through the discharge monitoring unit. Once the discharged cleaning fluid meets the requirements, the electrical control valve and positive pressure drive unit between the cleaning fluid supply unit 1 and the upper storage tank 100 are closed.

[0051] Third, close the drain ports of the lower storage tank 300 and the foam recovery tank 600, replace the cleaning solution in the cleaning solution supply unit 1 with disinfectant, open the electrically controlled valve at the cleaning solution supply unit 1, start the positive pressure drive unit, and discharge the disinfectant into the upper storage tank 100 and the foam recovery tank 600. After the liquid level in the lower storage tank 300 reaches the set requirement, close the positive pressure drive unit, soak for the set time, then open the drain ports of the lower storage tank 300 and the foam recovery tank 600, and flush with purified water until the pH value of the discharged liquid is neutral, thus completing the disinfection.

[0052] Fourth step: Open the electrical control valve at point 4 of the drying unit and introduce clean compressed air for purging and drying. After drying is complete, remove the cleaning system, and the negative pressure filling and capping equipment can be put into use.

[0053] It should be noted that in this specification, relational terms such as first and second are used only to distinguish one entity from several other entities, and do not necessarily require or imply any such actual relationship or order between these entities.

[0054] The cleaning system and method for negative pressure filling and capping equipment provided in this application have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the embodiments above are only for the purpose of helping to understand the solution and core ideas of this application. It should be noted that those skilled in the art can make several improvements and modifications to this application without departing from the principles of this application, and these improvements and modifications also fall within the protection scope of the claims of this application.

Claims

1. A cleaning system for a negative pressure filling and capping machine, characterized in that, include: Cleaning fluid supply unit (1), the cleaning fluid supply unit (1) is used to supply cleaning fluid; A positive pressure drive unit is used to deliver cleaning fluid into the upper storage tank (100) and foam recovery tank (600) of the negative pressure filling and capping equipment; A cleaning cup (2) is provided, which can be sealed with the filling needle (200) of the negative pressure filling and capping equipment. A cleaning chamber can be formed inside the cleaning cup (2). The filling needle (200) has an inner channel and an outer channel. One end of the inner channel is connected to the upper liquid storage tank (100) through a vacuum tube (400), and the other end is connected to the cleaning chamber. The filling needle (200) is provided with a return port. One end of the outer channel is connected to the return port, and the other end is connected to the cleaning chamber. The return port is connected to the lower liquid storage tank (300) of the negative pressure filling and capping equipment through a medicine hose (500). Both the foam recovery tank (600) and the lower liquid storage tank (300) are provided with drain ports.

2. The cleaning system for a negative pressure filling and capping equipment according to claim 1, characterized in that, The cleaning cup (2) has a sealing ring (3) at its mouth, which is used to seal with the filling needle (200).

3. The cleaning system for a negative pressure filling and capping equipment according to claim 2, characterized in that, The outer wall of the filling needle (200) is provided with a relief groove, which is flush with the sealing ring (3) to avoid direct contact between the outer wall of the filling needle (200) and the sealing ring (3).

4. The cleaning system for a negative pressure filling and capping equipment according to claim 1, characterized in that, A drying unit (4) is also provided, which can introduce clean compressed air into the upper liquid storage tank (100) and the foam recovery tank (600).

5. The cleaning system for a negative pressure filling and capping equipment according to claim 1, characterized in that, An emission monitoring unit is also provided, which is installed at each of the two discharge ports to monitor the discharged wastewater.

6. The cleaning system for a negative pressure filling and capping equipment according to claim 4, characterized in that, Both the cleaning fluid supply unit (1) and the drying unit (4) are equipped with electrically controlled valves at their input ends.

7. The cleaning system for a negative pressure filling and capping equipment according to claim 1, characterized in that, The upper liquid storage tank (100) and the lower liquid storage tank (300) are connected by a return pipe, and the return pipe is equipped with a control valve.

8. A cleaning method for a negative pressure filling and capping equipment, applied to the cleaning system for a negative pressure filling and capping equipment as described in any one of claims 1-7, characterized in that, include: Open the electrical control valve at the cleaning fluid supply unit (1), start the positive pressure drive unit, and discharge the cleaning fluid into the upper storage tank (100) and the foam recovery tank (600). The cleaning fluid in the upper storage tank (100) enters the filling needle (200) through the vacuum tube (400), then enters the cleaning cup through the inner channel of the filling needle (200), and enters the lower storage tank (300) through the outer channel of the filling needle (200) and the medicine hose (500). The cleaning fluid in the lower storage tank (300) and the foam recovery tank (600) is discharged through the drain port. The discharged cleaning fluid is detected by the discharge monitoring unit. Once the discharged cleaning fluid meets the requirements, the electrical control valve and positive pressure drive unit between the cleaning fluid supply unit (1) and the upper storage tank (100) are closed.

9. The cleaning method for a negative pressure filling and capping equipment according to claim 8, characterized in that, After the discharged cleaning fluid meets the requirements, the electrically controlled valve and positive pressure drive unit between the cleaning fluid supply unit (1) and the upper storage tank (100) are closed, and the process further includes: Close the drain ports of the lower storage tank (300) and the foam recovery tank (600), replace the cleaning solution in the cleaning solution supply unit (1) with disinfectant, open the electric control valve at the cleaning solution supply unit (1), start the positive pressure drive unit, and discharge the disinfectant into the upper storage tank (100) and the foam recovery tank (600). After the liquid level in the lower storage tank (300) reaches the set requirement, close the positive pressure drive unit, soak for a set time, open the drain ports of the lower storage tank (300) and the foam recovery tank (600), and flush with purified water until the pH value of the discharged liquid is neutral.

10. The cleaning method for a negative pressure filling and capping equipment according to claim 9, characterized in that, After rinsing with purified water until the pH of the effluent is neutral, the process further includes: Open the electrically controlled valve at the drying unit (4) and introduce clean compressed air for purging and drying.

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