Method for testing use performance of gasket for pen type insulin injector

Abstract

The invention discloses a method for testing the service performance of a gasket for a pen type insulin injector, and aims to solve the problem of lack of effective detection means in the prior art. The method comprises the three steps of gasket pretreatment, cartridge bottle assembly and simulated use test. And the gasket is boiled, washed, sterilized and dried to be used for sealing the cartridge bottle filled with distilled water. A simulated use test evaluates gasket performance by repeating the puncture process and checking leakage conditions. In a preferable scheme, the gasket is made of halogenated butyl rubber or isoprene-containing rubber, and during pretreatment, the gasket needs to be boiled for 5 minutes, sterilized by high-pressure steam and dried for 30 minutes at 105 DEG C. Injection needles of different specifications are adopted for simulated puncture, and leakage is judged through naked eye observation or a filter paper method. The method is simple in process and reliable in result, the sealing performance of the gasket after multiple times of puncture can be accurately evaluated, and an effective means is provided for product quality control.

Description

Technical Field

[0001] The invention relates to the technical field of medical experiments, and in particular to a method for testing the performance of a gasket for an insulin pen-type syringe. Background Art

[0002] As the number of patients with diabetes increases, insulin, as one of the main drugs for the treatment of diabetes, continues to grow in market demand. According to statistics, the number of insulin purchased in the first centralized purchase in 2021 reached about 218 million, indicating that there is a huge demand for insulin and its supporting components. However, due to the high technical difficulty of developing double-layer gaskets for pen-type syringes, only a few international companies (such as West and Datwyler) provide related products in the market, and domestic companies have not yet been able to launch corresponding products.

[0003] The gasket for pen syringes is a key medical rubber accessory, mainly used to seal cartridge bottles to ensure that there will be no leakage during use. During use by diabetics, the gasket will be constantly punctured by the insulin injection needle, so its sealing performance is crucial. If leakage occurs at the puncture site, it will not only cause contamination or deterioration of the drug solution, but may also delay the patient's treatment and even have an adverse effect on the patient's physical health; however, the current performance testing method for gaskets for pen syringes is still immature, and there is a lack of effective testing methods to ensure that the gasket can still maintain good sealing performance after multiple punctures. Therefore, it is particularly important to develop a test method that can accurately evaluate the performance of gaskets for insulin pen syringes. Summary of the invention

[0004] In view of the technical problems existing in the background technology, the present invention provides a method for testing the performance of a gasket for an insulin pen injector. The method effectively evaluates the performance of a gasket for a pen injector by simulating the number of punctures in actual use and checking whether leakage occurs at the puncture point, thereby ensuring its safety and reliability in actual applications.

[0005] In order to solve the above technical problems, the present invention adopts the following technical solutions to achieve: A method for testing the performance of a gasket for an insulin pen-type syringe, the method comprising the following steps: S1, gasket pretreatment; S1.1. Prepare the gasket for insulin pen syringe with aluminum cap, and place it in a clean, sufficiently large wide-mouth conical bottle to ensure that the gasket can move freely without obstruction; S1.2. Add enough distilled water to the conical flask to completely immerse the gasket. Place the conical flask on a heating device and heat the water until it boils. Keep boiling to ensure that any impurities on the surface of the gasket are removed. S1.3. After boiling, carefully remove the gasket from the conical flask and immediately rinse it thoroughly with running distilled water to remove any remaining impurities. S1.4. Put the gasket back into the conical flask again, put the conical flask into the high pressure steam sterilizer, and perform steam sterilization at high temperature to eliminate possible microorganisms; S1.5. After sterilization, take out the gasket from the conical flask and place it in a clean environment to dry naturally or use appropriate drying equipment to dry it. Finally, place the gasket after drying in a dust-free environment for later use; S2, cartridge assembly; S2.1. Prepare matching cartridges and equip each cartridge with a suitable piston; S2.2. Clean the cartridge and piston to ensure they are sterile; S2.3. Add an appropriate amount of distilled water to each cartridge to simulate insulin solution, use a sterilized and dried gasket, and seal the cartridge mouth according to standard operating procedures to ensure that the gasket is tightly combined with the cartridge mouth to ensure a good sealing effect; S3, simulated use test; S3.1. Place the sealed cartridge into the matching pen-type insulin injection pen; S3.2. Open the pen cap, screw the insulin injection needle into the injection pen, and make sure it is tightened. Then loosen the injection needle and remove it, simulating a complete puncture process. S3.3, repeat step S3.2, and after every 5 punctures, carefully check whether there is liquid leakage at the puncture hole. If leakage is found, record the specific information and stop the test. If no leakage is found, continue to repeat this process; S3.4. Continue to repeat this process until a total of 60 punctures are completed without any leakage, record the test results, and analyze the performance of the gasket under simulated use conditions.

[0006] In a preferred embodiment, the gasket material used in the syringe is halogenated butyl rubber or contains isoprene rubber.

[0007] In a preferred embodiment, in S1.2, the conical flask containing the sample gasket is boiled with purified water for 5 minutes and then rinsed with purified water 5 times. In S1.4, the conical flask containing the sample gasket is placed in a high-pressure steam sterilizer and heated to 121°C ± 2°C within 30 minutes and maintained for 30 minutes.

[0008] In a preferred embodiment, in S1.5, the drying condition of the sample gasket is to dry it in hot air at 105° C. for 30 minutes, and then take it out and store it in a sealed glass container for future use.

[0009] In a preferred embodiment, in S2.3, a nominal volume of distilled water is added to the cartridge, and after capping, the cartridge is observed to be free of bubbles to ensure that the distilled water fills the entire cartridge.

[0010] In a preferred embodiment, in S3.2, the method for simulating the complete puncture process is to pick up the pen-type insulin injection pen horizontally, pierce the gasket with the injection needle parallel to the injection pen, and then tighten the injection needle; The injection needle can be selected according to the usage: 31G×4mm (0.23mm×4TW LB); 31G×5mm (0.25mm×5TW LB); 31G×6mm (0.25mm×6TW LB).

[0011] In the preferred solution, in S3.3, the puncture hole is observed with the naked eye to seep out liquid. If the naked eye cannot accurately determine, the punctured surface of the gasket can be pressed against the surface of the filter paper to see if there are water marks on the surface of the filter paper to determine whether the gasket is leaking.

[0012] A method for testing the performance of a gasket for an insulin pen-type syringe, the beneficial effects of the method include but are not limited to the following points: 1. The present invention realizes the detection of the performance of the gasket for insulin pen injector for the first time by simulating the puncture process actually used by diabetic patients, which makes the test results closer to the actual use and improves the reliability and accuracy of the test; 2. The test process of the present invention is concise and easy to implement. It includes the steps of gasket pretreatment, cartridge assembly and simulated use test, etc. These steps can be completed with common laboratory equipment and tools without complicated instruments and equipment; 3. Evaluate the performance of the gasket by observing whether it leaks under simulated use conditions. This method is intuitive and easy to understand, making it easy to draw conclusions quickly. 4. Through a strict pretreatment process (including boiling, rinsing, sterilization and drying), the surface of the gasket is ensured to be clean and free of impurities, thereby ensuring the true reflection of the gasket performance in the subsequent testing process; 5. By using different specifications of injection needles (such as 31G×4mm, 31G×5mm, 31G×6mm) for puncture testing, different usage conditions can be simulated to comprehensively evaluate the durability and sealing performance of the gasket; 6. Use visual observation or filter paper method to determine whether the gasket has leakage. These two methods are simple and easy to use, suitable for laboratory environment, and also convenient for daily monitoring by the quality control department. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 This is a gasket image with no leakage after 60 acupunctures; Figure 2 This is a picture of a leaking gasket after 42 needle punctures (air bubbles in the cartridge); Figure 3 This is a picture of a leaking gasket after being punctured 10 times;. DETAILED DESCRIPTION

[0014] Embodiment 1: Prepare several gaskets with aluminum caps, a set of reusable pen-type insulin injection pen covers, 10 matching cartridges, 10 matching plugs for the cartridges, and a box of matching injection needles; Experimental steps: S1. Place 10 insulin pen syringes with aluminum caps in a wide-mouth conical flask, add purified water and boil for 5 minutes, then rinse with purified water 5 times, place the gasket in the conical flask, cover it with aluminum foil or borosilicate beaker, place it in a high-pressure steam sterilizer and heat it to 121℃±2℃ and keep it for 30 minutes, cool it naturally, dry it in hot air at 105℃ for 30 minutes, and store the dried gasket in a sealed glass container for later use; S2. Add the nominal volume of water into each cartridge, ensure that there are no bubbles in the bottle, and seal the cartridge mouth with a sterilized and dried gasket; S3. Place the cartridge into the matching pen-type insulin injection pen, insert the injection needle into the gasket while keeping it parallel to the injection pen, tighten the injection needle, and then withdraw it. Check for liquid leakage after every 5 punctures. If there is no leakage during the puncture process, continue until 60 punctures are completed.

[0015] The puncture results are shown in Table 1.

[0016] Table 1 Performance test results of gaskets for insulin pen-type syringes of manufacturer A (such as Figure 1 shown)

[0017] Embodiment 2: Prepare several gaskets with aluminum caps, a set of reusable pen-type insulin injection pen covers, 10 matching cartridges, 10 matching plugs for the cartridges, and a box of matching injection needles; Experimental steps: S1. Place 10 insulin pen syringes with aluminum caps in a wide-mouth conical flask, add purified water and boil for 5 minutes, then rinse with purified water 5 times, place the gasket in the conical flask, cover it with aluminum foil or borosilicate beaker, place it in a high-pressure steam sterilizer and heat it to 121℃±2℃ and keep it for 30 minutes, cool it naturally, dry it in hot air at 105℃ for 30 minutes, and store the dried gasket in a sealed glass container for later use; S2. Add a nominal volume of water into each cartridge, with a small amount of bubbles in the bottle, and seal the cartridge mouth with a sterilized and dried gasket; S3. Place the cartridge into the matching pen-type insulin injection pen, insert the injection needle into the gasket while keeping it parallel to the injection pen, tighten the injection needle, and then withdraw it. Check for liquid leakage after every 5 punctures. If there is no leakage during the puncture process, continue until 60 punctures are completed.

[0018] The puncture results are shown in Table 2.

[0019] Table 2 Performance test results of gaskets for insulin pen syringes from manufacturer A (e.g. Figure 2 shown)

[0020] Embodiment 3: Prepare several gaskets with aluminum caps, a set of reusable pen-type insulin injection pen covers, 10 matching cartridges, 10 matching plugs for the cartridges, and a box of matching injection needles; Experimental steps: S1. Place 10 insulin pen syringes with aluminum caps in a wide-mouth conical flask, add purified water and boil for 5 minutes, then rinse with purified water 5 times, place the gasket in the conical flask, cover it with aluminum foil or borosilicate beaker, place it in a high-pressure steam sterilizer and heat it to 121℃±2℃ and keep it for 30 minutes, cool it naturally, dry it in hot air at 105℃ for 30 minutes, and store the dried gasket in a sealed glass container for later use; S2. Add the nominal volume of water to each cartridge, make sure that the liquid fills the entire cartridge, shake the cartridge until bubbles appear, and seal the cartridge mouth with a sterilized and dried gasket; S3. Place the cartridge into the matching pen-type insulin injection pen, insert the injection needle into the gasket while keeping it parallel to the injection pen, tighten the injection needle, and then withdraw it. Check for liquid leakage after every 5 punctures. If there is no leakage during the puncture process, continue until 60 punctures are completed.

[0021] The puncture results are shown in Table 3.

[0022] Table 3 Performance test results of gaskets for insulin pen-type syringes of manufacturer A (such as Figure 2 shown)

[0023] Embodiment 4: Prepare several gaskets with aluminum caps, a set of reusable pen-type insulin injection pen covers, 10 matching cartridges, 10 matching plugs for the cartridges, and a box of matching injection needles; Experimental steps: S1. Place 10 insulin pen syringes with aluminum caps in a wide-mouth conical flask, add purified water and boil for 5 minutes, then rinse with purified water 5 times, place the gasket in the conical flask, cover it with aluminum foil or borosilicate beaker, place it in a high-pressure steam sterilizer and heat it to 121℃±2℃ and keep it for 30 minutes, cool it naturally, dry it in hot air at 105℃ for 30 minutes, and store the dried gasket in a sealed glass container for later use; S2. Add the nominal volume of water to each cartridge bottle, ensure that there are no bubbles in the bottle, and seal the cartridge bottle mouth with a sterilized and dried gasket, but do not completely tighten the bottle mouth when sealing; S3. Place the cartridge into the matching pen-type insulin injection pen, insert the injection needle into the gasket while keeping it parallel to the injection pen, tighten the injection needle, and then withdraw it. Check for liquid leakage after every 5 punctures. If there is no leakage during the puncture process, continue until 60 punctures are completed.

[0024] Table 4 Performance test results of gaskets for insulin pen syringes from manufacturer A (e.g. Figure 3 shown)

[0025] It can be seen from the data in Tables 1 to 4 that if bubbles appear in the cartridge or the cap is not tightly rolled, resulting in bubbles in the cartridge solution, the test results will be affected. Examples 1 to 4 can also well prove that this method can be used to test the performance of gaskets for insulin pen injectors, and is suitable for quality control of leakage during the use of gaskets for insulin pen injectors.

[0026] 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 method for testing the performance of a gasket for an insulin pen injector. Features: The test method includes the following steps: S1, gasket pretreatment; S1.

1. Prepare the gasket for insulin pen syringe with aluminum cap, and place it in a clean, sufficiently large wide-mouth conical bottle to ensure that the gasket can move freely without obstruction; S1.

2. Add enough distilled water to the conical flask to completely immerse the gasket. Place the conical flask on a heating device and heat the water until it boils. Keep boiling to ensure that any impurities on the surface of the gasket are removed. S1.

3. After boiling, carefully remove the gasket from the conical flask and immediately rinse it thoroughly with running distilled water to remove any remaining impurities. S1.

4. Put the gasket back into the conical flask again, put the conical flask into the high pressure steam sterilizer, and perform steam sterilization at high temperature to eliminate possible microorganisms; S1.

5. After sterilization, take out the gasket from the conical flask and place it in a clean environment to dry naturally or use appropriate drying equipment to dry it. Finally, place the gasket after drying in a dust-free environment for later use; S2, cartridge assembly; S2.

1. Prepare matching cartridges and equip each cartridge with a suitable piston; S2.

2. Clean the cartridge and piston to ensure they are sterile; S2.

3. Add an appropriate amount of distilled water to each cartridge to simulate insulin solution, use a sterilized and dried gasket, and seal the cartridge mouth according to standard operating procedures to ensure that the gasket is tightly combined with the cartridge mouth to ensure a good sealing effect; S3, simulated use test; S3.

1. Place the sealed cartridge into the matching pen-type insulin injection pen; S3.

2. Open the pen cap, screw the insulin injection needle into the injection pen, and make sure it is tightened. Then loosen the injection needle and remove it, simulating a complete puncture process. S3.3, repeat step S3.2, and after every 5 punctures, carefully check whether there is liquid leakage at the puncture hole. If leakage is found, record the specific information and stop the test. If no leakage is found, continue to repeat this process; S3.

4. Continue to repeat this process until a total of 60 punctures are completed without any leakage, record the test results, and analyze the performance of the gasket under simulated use conditions.

2. The method for testing the performance of the insulin pen syringe gasket according to claim 1, Features: The gasket material used for the syringe is halogenated butyl rubber or contains isoprene rubber.

3. The method for testing the performance of the insulin pen injector gasket according to claim 1, Features: In S1.2, the conical flask containing the sample septum is boiled in purified water for 5 minutes and then rinsed 5 times with purified water. In S1.4, the conical flask containing the sample septum is placed in a high pressure steam sterilizer and heated to 121°C ± 2°C within 30 minutes and maintained for 30 minutes.

4. The method for testing the performance of the insulin pen syringe gasket according to claim 1, Features: In S1.5, the drying condition of the sample pad is to dry it in hot air at 105° C. for 30 minutes, and then take it out and store it in a sealed glass container for future use.

5. The method for testing the performance of the insulin pen syringe gasket according to claim 1, Features: In S2.3, add the nominal volume of distilled water to the cartridge, and observe that there are no bubbles in the cartridge after crimping to ensure that the distilled water fills the entire cartridge.

6. The method for testing the performance of the insulin pen injector gasket according to claim 1, Features: In S3.2, the method for simulating the complete puncture process is to hold the pen-type insulin injection pen horizontally, pierce the gasket with the injection needle parallel to the injection pen, and then tighten the injection needle; The injection needle can be selected according to the usage: 31G×4mm (0.23mm×4TW LB); 31G×5mm (0.25mm×5TWLB); 31G×6mm (0.25mm×6TW LB).

7. The method for testing the performance of the insulin pen injector gasket according to claim 1, Features: In S3.3, observe with the naked eye whether there is liquid seeping out of the puncture hole. If the naked eye cannot accurately judge, the punctured surface of the gasket can be pressed against the surface of the filter paper to determine whether the gasket is leaking by observing whether there are water marks on the surface of the filter paper.

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