Testing device and testing method for evaluating filling running smoothness of butyl rubber plug

Abstract

The invention relates to a testing device and a testing method for evaluating butyl rubber plug filling running smoothness, the device comprises a detection platform, a horizontal base, an angle sensor, an angle driving device and a control console, four corners of the lower end face of the horizontal base are provided with adjustable support legs, and the upper end face of the horizontal base is provided with the detection platform; a placement groove is formed in the upper end face of the horizontal base, an angle driving device is installed in the placement groove and drives the detection platform to turn over to adjust the angle, a photoelectric sensor is installed on the detection platform, an angle sensor is installed at the bottom of the detection platform, and a console is installed on the side portion of the detection platform; according to the butyl rubber plug filling running performance evaluation device, the butyl rubber plug filling running performance can be rapidly and accurately evaluated, the butyl rubber plug filling running performance evaluation device has the advantages of being simple and easy to operate, and rubber plug production and technical improvement of pharmaceutical enterprises can be effectively supported.

Description

Technical Field

[0001] The invention relates to the technical field of drug packaging material detection, and in particular to a test device and a test method for evaluating the smoothness of a butyl rubber plug filling machine. Background Art

[0002] Sterile injections are an indispensable and important part of the modern medical field, and their quality directly affects the treatment effect and life safety of patients. As one of the key components of the sterile injection sealing system, butyl rubber stoppers, together with vials and aluminum-plastic combination caps, form a closed sealing system, which is crucial to ensure the quality and safety of drugs. Butyl rubber stoppers are widely used in the packaging of various sterile injections due to their excellent chemical stability and low permeability.

[0003] In the production process of injections, pharmaceutical companies usually use high-speed filling machines to accurately dispense liquid medicine into vials. Butyl rubber stoppers are fed through the oscillating hopper of the filling machine equipment, then move along the stopper guide rail and cooperate with the vial to complete the plugging operation, thereby achieving the initial packaging of the injection. This process is called the filling and running process of butyl rubber stoppers. With the development of pharmaceutical technology, the speed of aseptic filling of drugs continues to increase, which puts higher requirements on the running speed and smoothness of butyl rubber stoppers during the filling process; however, the existing evaluation methods for the smoothness of butyl rubber stopper filling often rely on experience judgment or more complex experimental methods, and lack a standardized, efficient and accurate evaluation system. Summary of the invention

[0004] In view of the technical problems existing in the background technology, the present invention provides a test device and a test method for evaluating the smoothness of the filling and running of butyl rubber stoppers, which can not only quickly and accurately evaluate the filling and running performance of butyl rubber stoppers, but also has the characteristics of being simple and easy to operate, and can effectively support the technology improvement of rubber stopper production and pharmaceutical companies.

[0005] In order to solve the above technical problems, the present invention adopts the following technical solutions to achieve: A test device for evaluating the smoothness of a butyl rubber plug filling machine comprises a detection platform, a horizontal base, an angle sensor, an angle driving device and a control console. Adjustable feet are arranged at the four corners of the lower end surface of the horizontal base, a detection platform is arranged at the upper end surface of the horizontal base, a placement groove is opened on the upper end surface of the horizontal base, an angle driving device is arranged in the placement groove and drives the detection platform to flip and adjust the angle, a photoelectric sensor is arranged on the detection platform, an angle sensor is arranged at the bottom of the detection platform, a control console is arranged on the side of the detection platform, and the control console is electrically connected with the photoelectric sensor, the angle driving device and the angle sensor through a cable.

[0006] In a preferred solution, a liquid level is provided at the upper end surface of the horizontal base.

[0007] In a preferred solution, the bottom surface of the detection platform is vertically connected to the side wall of the rotating shaft, the two ends of the rotating shaft are rotatably connected to the shaft seat, the shaft seat is vertically installed on the horizontal base, and the rotating shaft rotates freely around its own axis.

[0008] In a preferred embodiment, the angle driving device includes a servo motor, which is installed in a placement slot and connected to a control console via a cable. The servo motor is hinged to one end of a connecting rod, and the other end of the connecting rod is hinged to the bottom surface of the detection platform via a hinge. The servo motor drives the detection platform to rotate around the axis of the rotating shaft via the connecting rod.

[0009] In a preferred solution, a rubber plug guide plate is placed at the center of the detection platform, and the rubber plug guide plate is placed parallel to the upper end surface of the detection platform.

[0010] In a preferred solution, a slide groove is provided at the upper end surface of the rubber plug guide plate, and a placement opening is provided at the end of the slide groove.

[0011] In a preferred solution, guide rods are arranged in parallel on both sides of the rubber plug guide plate, and photoelectric sensors are sleeved on the guide rods. The photoelectric sensors slide along the guide rods and can be fixed in position.

[0012] A test method for evaluating the smoothness of butyl rubber plug filling, the method comprising the following steps: S1. Take 10 rubber stopper samples to be tested, package them in breathing packaging bags, and place them in a high-pressure steam sterilizer for wet heat sterilization at 121℃±2℃ for 30 minutes. After sterilization, dry the samples; S2. The control console sends a command signal to the angle drive device to adjust the flip angle of the detection platform to a 0° horizontal position, and uses a liquid level to calibrate the horizontality of the horizontal base, and ensures that the entire device is in a horizontal state by adjusting the four supporting feet on the lower side of the horizontal base; S3, weighing the mass m of a single rubber plug sample after being processed in step S1, and then placing the rubber plug sample into the slide groove from the circular placement opening above the rubber plug guide plate, and adjusting the position of the photoelectric sensor to fix it on both sides of the rubber plug; S4. Press the start button on the main control box to start the test. The servo motor runs and drives the detection platform to slowly flip and tilt. When the detection platform tilts to a certain angle and the rubber plug starts to slide in the slide, the photoelectric sensor sends a signal to the control console, which stops the servo motor immediately and records the tilt angle α output by the angle sensor at the same time. S5. Calculate the total resistance f of each rubber plug in the guide rail based on the angle α measured in step S4. 总 , the calculation formula is: 总 = m × g × sinα; (where g is the acceleration due to gravity, which is 9.8 N / kg; m is the mass of the rubber plug; α is the flip angle of the detection platform (1)); S6. Repeat steps S3 to S5 to test the remaining 9 rubber plug samples, obtain the inclination angle α and mass m of each sample, and calculate the total resistance f. 总 And find the average value f 平 , with this average value f 平 To characterize the filling smoothness performance of butyl rubber stopper, where f 平 The smaller the value, the better the running smoothness of the butyl rubber plug.

[0013] A test device and test method for evaluating the smoothness of butyl rubber plug filling, which has the following advantages in practical application: 1. The test device of the present invention can accurately measure the critical angle α of the butyl rubber plug when it moves on the guide rail, and combine the mass m of the rubber plug to use the formula f 总 = m × g × sinα to calculate the total resistance ftotal of the rubber plug. By calculating the average value f of multiple samples 平 , and realized the quantitative evaluation of the smoothness performance of the butyl rubber plug filling machine; 2. The present invention uses automatic components such as angle sensors, light sensors and servo motors to ensure the accuracy of the measurement results. The angle sensor accurately measures the tilt angle α when the rubber plug starts to slide, the light sensor accurately captures the moment when the rubber plug slides, and the servo motor ensures the stability and precise tilt of the test platform, all of which make the measurement results more reliable; 3. Due to the use of automated control and measurement methods, the present invention can significantly reduce the time required for testing and improve evaluation efficiency. This is particularly important for pharmaceutical companies and rubber plug manufacturers that need to frequently test the performance of different batches of rubber plugs; 4. The method of the present invention is not only applicable to butyl rubber plugs, but can also be extended to the testing of other types of rubber plugs or similar materials, and has wide applicability. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 It is a schematic diagram of the overall structure of the present invention; Figure 2 It is a side view of the overall structure of the present invention; Figure 3 It is a top view of the overall structure of the present invention; Figure 4 This is a force analysis diagram of the butyl rubber plug when it moves in the rubber plug guide.

[0015] In the figure: detection platform 1, horizontal base 2, placement groove 201, support foot 3, guide rod 4, rubber plug guide 5, slide groove 501, placement port 502, angle sensor 6, photoelectric sensor 7, control console 8, connecting rod 9, servo motor 10, liquid level 11, hinge 12, cable 13, rotating shaft 14, shaft seat 15. DETAILED DESCRIPTION

[0016] like Figure 1 and Figure 2 As shown, a test device for evaluating the smoothness of butyl rubber plug filling, comprises a detection platform 1, a horizontal base 2, an angle sensor 6, an angle driving device and a control console 8. Adjustable feet 3 are arranged at the four corners of the lower end surface of the horizontal base 2, and the detection platform 1 is arranged at the upper end surface of the horizontal base 2. A placement groove 201 is opened on the upper end surface of the horizontal base 2. The angle driving device is arranged in the placement groove 201 and drives the detection platform 1 to rotate stably in the range of 0°-90°. A photoelectric sensor 7 is arranged on the detection platform 1, an angle sensor 6 is arranged at the bottom of the detection platform 1, and a control console 8 is arranged on the side of the detection platform 1. The control console 8 is electrically connected with the photoelectric sensor 7, the angle driving device and the angle sensor 6 through a cable 13.

[0017] The preferred solution is Figure 1 As shown, a liquid level 11 is provided at the upper end surface of the horizontal base 2, and the levelness of the horizontal base 2 can be monitored by the liquid level 11. The top of the support leg 3 is threadedly connected to the lower end surface of the horizontal base 2 through a screw, and the levelness of the horizontal base 2 can be adjusted in conjunction with the liquid level 11.

[0018] The preferred solution is Figure 3 As shown, the bottom surface of the detection platform 1 is vertically connected to the side wall of the rotating shaft 14, and the two ends of the rotating shaft 14 are rotatably connected to the shaft seat 15. The shaft seat 15 is vertically installed on the horizontal base 2, and the rotating shaft 14 rotates freely around its own axis.

[0019] The preferred solution is Figure 2 As shown, the angle driving device includes a servo motor 10, which is installed in the placement groove 201 and connected to the control console 8 through a cable 13. The servo motor 10 is hinged to one end of the connecting rod 9, and the other end of the connecting rod 9 is hinged to the bottom surface of the detection platform 1 through a hinge 12. The servo motor 10 drives the detection platform 1 to rotate around the axis of the rotating shaft 14 through the connecting rod 9.

[0020] The preferred solution is Figure 3 As shown, a rubber plug guide plate 5 is placed at the center of the detection platform 1. The rubber plug guide plate 5 is placed parallel to the upper end surface of the detection platform 1. When the detection platform 1 is horizontal, the detection platform 1 also maintains a corresponding level.

[0021] The preferred solution is Figure 3As shown, a slide groove 501 is provided at the upper end surface of the rubber plug guide plate 5, and a placement opening 502 is provided at the end of the slide groove 501. The rubber plug guide plate 5 should be made of 304 stainless steel, and the surface roughness of the inner slide groove 501 should be less than 0.6 μm. The preferred solution is Figure 1 and Figure 3 As shown, guide rods 4 are arranged in parallel on both sides of the rubber plug guide plate 5, and photoelectric sensors 7 are sleeved on the guide rods 4. The photoelectric sensors 7 can slide along the guide rods 4 and can be fixed in position; the photoelectric sensors 7 can slide relatively to the sample position and be fixed to sense the dynamics of the rubber plug sample. When the rubber plug sample slides, the photoelectric sensor 7 sends a signal to stop the servo motor immediately and maintain the inclination angle of the detection platform 1.

[0022] Example: S1. Take 10 13-D1 (state 1) rubber stopper samples to be tested, package them in breathing packaging bags, and place them in a high-pressure steam sterilizer for wet heat sterilization at 121℃±2℃ for 30 minutes. After sterilization, dry the samples; S2, the control console 8 sends a command signal to the angle driving device to adjust the flip angle of the detection platform 1 to a horizontal position of 0°, and calibrates the horizontality of the horizontal base 2 using a liquid level 11, and ensures that the entire device is in a horizontal state by adjusting the four legs 3 on the lower side of the horizontal base 2; S3, weighing the mass m of a single rubber plug sample after being processed in step S1, and then placing the rubber plug sample into the slide groove 501 from the circular placement opening 502 above the rubber plug guide plate 5, and adjusting the position of the photoelectric sensor 7 to fix it on both sides of the rubber plug; S4, the start button on the main control box is turned on to start the test, the servo motor 10 runs and drives the detection platform 1 to slowly flip and tilt, when the detection platform 1 tilts to a specific angle causing the rubber plug to start sliding in the slide groove 501, the photoelectric sensor 7 sends a signal to the control console 8, and the control console 8 stops the servo motor 10 immediately and records the tilt angle α output by the angle sensor 6 at the same time; S5. Calculate the total resistance f of each rubber plug in the guide rail based on the angle α measured in step S4. 总 , the calculation formula is: 总 = m × g × sinα; (e.g. Figure 4 shown) (where g is the acceleration of gravity, which is 9.8N / kg; m is the mass of the rubber plug; α is the flip angle of the detection platform 1); S6. Repeat steps S3 to S5 to test the remaining 9 rubber plug samples, obtain the inclination angle α and mass m of each sample, and calculate the total resistance f. 总 And find the average value f 平, with this average value f 平 To characterize the filling smoothness performance of butyl rubber stopper, where f 平 The smaller the value, the better the running smoothness of the butyl rubber plug; The data measured according to the above test device and test method are shown in Table 1 below: Table 1 13-D1 (state 1) rubber plug measurement data

[0023] Example 2: The test equipment and test method in Example 1 are used to measure the relevant data of the 13-D1 (state 2) model product, and the measured data results are shown in Table 2 below; Table 2 13-D1 (state 2) rubber plug measurement data

[0024] Example 3: The test equipment and test method in Example 1 are used to measure the relevant data of the 13-D1 (state 3) model product, and the measured data results are shown in Table 3 below; Table 3 13-D1 (state 3) rubber plug measurement data

[0025] Example 4: The test equipment and test method in Example 1 are used to measure the relevant data of the 13-D1 (state 4) model product, and the measured data results are shown in Table 4 below; Table 4 13-D1 (state 4) rubber plug measurement data

[0026] The test equipment and test methods used in Examples 1-4 are the same, and the sample structures tested are the same, except that: The 13-D1 (state 1) sample tested in Example 1 was siliconized by adding 1.8 ml / 10,000 pieces of 500# silicone oil during cleaning and siliconization; The 13-D1 (state 2) sample tested in Example 2 was siliconized by adding 0.6 ml / 10,000 pieces of 500# silicone oil during cleaning and siliconization; The 13-D1 (state 3) sample tested in Example 3 was siliconized by adding 1.2 ml / 10,000 silicone oil during cleaning and siliconization; The 13-D1 (state 4) sample tested in Example 4 was siliconized by adding 2.4 ml / 10,000 pieces of 500# silicone oil during cleaning and siliconization; (Siliconization treatment: after the butyl rubber stopper is cleaned, a layer of dimethyl silicone oil film is attached to its surface and dried and solidified. This oil film layer can play a lubricating role, so that the rubber stopper can be smoothly transmitted on the oscillating bucket and screw conveyor of the high-speed filling machine. Usually, the more silicone oil is used during siliconization treatment, the smoother the rubber stopper will be).

[0027] In order to further verify the rationality of the test device and test method, the rubber plug samples in Examples 1-4 were tested for the rubber plug running speed. The higher the running speed, the better the running smoothness of the product. The specific method is: the rubber plug samples in Examples 1-4 are placed in the butyl rubber plug running equipment of the filling line, and after the machine is started, the rubber plugs supplied within 5 minutes are taken at the end of the rubber plug guide rail, and the specific number of rubber plugs is counted to obtain the number of rubber plugs supplied per minute. The final test results are shown in Table 5 below: Table 5 Rubber plug sample status, test results and actual machine speed information of Examples 1-4

[0028] It can be seen from the data in the table that the f of the rubber plug samples tested in Examples 1-4 is 总 The value is positively correlated with the actual running speed. Therefore, the test device and test method for evaluating the running smoothness of butyl rubber plug filling provided by the present invention can quickly evaluate the running smoothness performance of butyl rubber plug products during filling, and quantify the running smoothness performance of the plug. It is obvious to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the present invention can be implemented in other specific forms without departing from the spirit or essential features of the present invention. Therefore, the embodiments should be regarded as exemplary and non-restrictive from all points of view, and the scope of the present invention is defined by the appended claims rather than the above description, and it is intended that all changes falling within the meaning and scope of the equivalent elements of the claims are included in the present invention; any reference numerals in the claims should not be regarded as limiting the claims involved.

Claims

1. A test device for evaluating the smoothness of a butyl rubber plug filling machine, comprising a detection platform (1), a horizontal base (2), an angle sensor (6), an angle drive device and a control console (8), characterized in that: Adjustable feet (3) are arranged at the four corners of the lower end surface of the horizontal base (2), a detection platform (1) is arranged at the upper end surface of the horizontal base (2), a placement groove (201) is opened on the upper end surface of the horizontal base (2), an angle driving device is arranged in the placement groove (201) and drives the detection platform (1) to flip and adjust the angle, a photoelectric sensor (7) is arranged on the detection platform (1), an angle sensor (6) is arranged at the bottom of the detection platform (1), and a control console (8) is arranged on the side of the detection platform (1), and the control console (8) is electrically connected to the photoelectric sensor (7), the angle driving device and the angle sensor (6) through a cable (13).

2. The device for evaluating the smoothness of butyl rubber plug filling according to claim 1 is characterized in that: A liquid level (11) is provided at the upper end surface of the horizontal base (2).

3. The device for evaluating the smoothness of butyl rubber plug filling according to claim 1 is characterized in that: The bottom surface of the detection platform (1) is vertically connected to the side wall of the rotating shaft (14), and the two ends of the rotating shaft (14) are rotatably connected to the shaft seat (15). The shaft seat (15) is vertically installed on the horizontal base (2), and the rotating shaft (14) is freely rotatable around its own axis.

4. The device for evaluating the smoothness of butyl rubber plug filling according to claim 3 is characterized in that: The angle driving device comprises a servo motor (10), which is installed in the placement groove (201) and connected to the control console (8) via a cable (13). The servo motor (10) is hinged to one end of a connecting rod (9), and the other end of the connecting rod (9) is hinged to the bottom surface of the detection platform (1) via a hinge (12). The servo motor (10) drives the detection platform (1) to rotate around the axis of the rotating shaft (14) via the connecting rod (9).

5. The device for evaluating the smoothness of butyl rubber plug filling according to claim 1 is characterized in that: A rubber plug guide plate (5) is placed at the center of the detection platform (1), and the rubber plug guide plate (5) is placed parallel to the upper end surface of the detection platform (1).

6. The device for evaluating the smoothness of butyl rubber plug filling according to claim 5 is characterized in that: A slide groove (501) is provided at the upper end surface of the rubber plug guide plate (5), and a placement opening (502) is provided at the end of the slide groove (501).

7. The device for evaluating the smoothness of butyl rubber plug filling according to claim 1 is characterized in that: Guide rods (4) are arranged in parallel on both sides of the rubber plug guide plate (5), and photoelectric sensors (7) are sleeved on the guide rods (4). The photoelectric sensors (7) slide along the guide rods (4) in a limited position and can be fixed in position.

8. A test method for evaluating the smoothness of butyl rubber plug filling, characterized in that: The method comprises the following steps: S1. Take 10 rubber stopper samples to be tested, package them in breathing packaging bags, and place them in a high-pressure steam sterilizer for wet heat sterilization at 121℃±2℃ for 30 minutes. After sterilization, dry the samples; S2, the control console (8) sends a command signal to the angle driving device to adjust the flip angle of the detection platform (1) to a horizontal position of 0°, and calibrates the horizontality of the horizontal base (2) using a liquid level (11), and ensures that the entire device is in a horizontal state by adjusting the four supporting legs (3) on the lower side of the horizontal base (2); S3, weighing the mass m of a single rubber plug sample after being processed in step S1, and then placing the rubber plug sample into the slide groove (501) from the circular placement opening (502) above the rubber plug guide plate (5), and adjusting the position of the photoelectric sensor (7) so that it is fixed on both sides of the rubber plug; S4, the start button on the main control box is turned on to start the test, the servo motor (10) is operated and drives the detection platform (1) to slowly flip and tilt, when the detection platform (1) tilts to a specific angle causing the rubber plug to start sliding in the slide groove (501), the photoelectric sensor (7) sends a signal to the control console (8), and the control console (8) stops the servo motor (10) immediately and simultaneously records the tilt angle α output by the angle sensor (6); S5. Calculate the total resistance f of each rubber plug in the guide rail based on the angle α measured in step S4. 总 , the calculation formula is: 总 = m × g × sinα; (where g is the acceleration due to gravity, which is 9.8 N / kg; m is the mass of the rubber plug; α is the flip angle of the detection platform (1)); S6. Repeat steps S3 to S5 to test the remaining 9 rubber plug samples, obtain the inclination angle α and mass m of each sample, and calculate the total resistance f. 总 And find the average value f 平 , with this average value f 平 To characterize the filling smoothness performance of butyl rubber stopper, where f 平 The smaller the value, the better the running smoothness of the butyl rubber plug.

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