Test method for compliance of injector

Abstract

The invention discloses a method for testing compliance of an injector. According to the invention, by optimizing the test device and using a high-precision sensor and data analysis software, efficient, accurate and repeatable evaluation of the compliance of the injector is realized. According to the method, the compliance characteristics such as linearity and sensitivity of the injector can be comprehensively analyzed, the design of the injector can be guided, and the injection precision and the injection speed are improved. Besides, the pressure injector does not need to be disassembled every time, the displacement of the pressure injector can be easily obtained after calculation through the displacement sensor and the customized pressure injector, errors caused by reading are greatly solved, and redundant steps in an experiment are reduced. The method can also be applied to various injectors, and powerful support is provided for technical progress and development of the injector industry.

Description

Technical Field

[0001] The invention belongs to the technical field of syringe testing, in particular to a test method for syringe compliance. Background Art

[0002] The syringe compliance test is a test of the compliance performance of the syringe during use, which aims to ensure the convenience and safety of the syringe in actual operation. The following is a detailed introduction to the syringe compliance test: The contents of the syringe compliance test include: Test samples: Select representative syringe samples, including products of different specifications, models and manufacturers. Test equipment: Use a professional syringe compliance tester to ensure the accuracy and reliability of the test results. Test method: According to national standards or industry standards, the syringe is tested for the following items: a. Push force test: simulate the force required to push the liquid during actual use to evaluate the smoothness of the syringe push. b. Tensile force test: simulate the force required to pull the piston when extracting the liquid, and evaluate the tensile performance of the syringe. c. Wall thickness uniformity test: Check whether the thickness of the syringe barrel wall is uniform to ensure the stability of the liquid injection process. d. Sealing performance test: Detect the sealing performance of each component of the syringe to prevent liquid leakage. Result judgment: According to the test data, the compliance performance of the syringe is evaluated to determine whether it meets the national standards or industry standards.

[0003] However, the traditional method has the following problems in syringe compliance testing: it is cumbersome to disassemble and assemble the pressurized syringe each time, and it is difficult to read the scale of the pressurized syringe during the test, which often leads to inaccurate test results and large errors. Summary of the invention

[0004] The object of the present invention is to provide a test method for syringe compliance in order to solve the above-mentioned problems.

[0005] The technical solution adopted by the present invention is as follows: a test method for syringe compliance, the method comprising the following steps:

[0006] S1: Prepare the test device, clean the syringe to be tested and fill it with distilled water until the nominal capacity, ensuring that all air in the system is exhausted. Fix the syringe to be tested on the adjustable fixing plate, ensuring that the core rod is firmly clamped and cannot move in the jacket;

[0007] S2: Connect the displacement sensor to the pressurized syringe to ensure that the displacement can be accurately measured. Connect the customized pressurized syringe to the test device and ensure that it is firmly connected. Connect the digital pressure gauge to the pressurized syringe to display the applied pressure value in real time. Connect the three-way valve to the syringe under test and the pressurized syringe to control the direction of liquid flow. Connect the water pipe to the pressurized syringe and ensure that it is firmly connected;

[0008] S3: Connect the data acquisition and processing system to the displacement sensor and digital pressure gauge equipment to collect and process data. Turn on the data acquisition and processing system and ensure that it operates normally;

[0009] S4: Set up the liquid system and use three-way valve 2 to isolate the syringe under test from the pressurized syringe and the pressure gauge. Use three-way valve 1 to fill the pressurized syringe with water; apply pressure and record the data, and use the pressurized syringe to apply the pressures given in Table 1 to the liquid system in turn. Record the maximum displacement volume of the pressurized syringe at each pressure. Use the three-way valve to connect the syringe under test to the pressurized syringe and the pressure gauge.

[0010] S5: Repeatedly use the three-way valve 1 to fill the pressurized syringe with water and note the data of the maximum displacement volume in the pressurized syringe when each test pressure is reached, and record the data to ensure that each pressure point has an experimental record;

[0011] S6: Calculate compliance. Calculate the compliance of the syringe under test at each pressure using the formula:

[0012] Compliance = (maximum displacement volume - initial volume) / pressure; where the maximum displacement volume is based on the formula:

[0013] Maximum displacement volume = π*(φ / 2) 2 *L;

[0014] The unit is mL, where φ represents the nominal inner diameter of the pressurized syringe, and L represents the displacement of the pressurized syringe during the test; the initial volume is the nominal capacity of the syringe under test. Record and analyze the compliance data at each pressure point to evaluate the compliance performance of the syringe under test;

[0015] S7: Import the test data into the data analysis software and draw the pressure-compliance curve. Analyze the curve trend and evaluate the compliance characteristics of the tested syringe;

[0016] S8: Based on the test results, discuss the impact of the compliance of the tested syringe on drug injection. Compare it with the compliance data of other syringes and analyze its advantages and disadvantages;

[0017] S9: Summarize the experimental results, draw conclusions, and make suggestions for improvement;

[0018] S10: Turn off the data acquisition and processing system. Disconnect all connections and clean up the test equipment. Turn off the data acquisition and processing system. Disconnect all connections and clean up the test equipment.

[0019] S11: Write a test report, including the test purpose, methods, results, discussion and conclusions. Archive the test report, data files and test device photos, and then the entire syringe compliance test process is completed.

[0020] In a preferred embodiment, in step S1, a syringe with a nominal capacity of 5 mL is selected to ensure that its inner diameter meets the test requirements. High-purity distilled water is used, and the air in the syringe is exhausted by multiple suctions until the syringe is filled with distilled water. The syringe to be tested is fixed on an adjustable fixing plate, and a special clamp is used to clamp the core rod to ensure that it does not move or rotate during the test. A displacement sensor with an accuracy of 0.01 mm is selected and installed on the pressurized syringe to ensure that its displacement can be accurately measured.

[0021] In a preferred embodiment, in step S8, a customized pressurized syringe with a nominal inner diameter of 2.5 mm is selected and connected to the test device to ensure a stable connection. A digital pressure gauge with an accuracy of 0.01 MPa is selected and connected to the pressurized syringe to display the applied pressure value in real time. A three-way valve is selected and connected to the tested syringe and the pressurized syringe to ensure flexible operation and accurate control of the direction of liquid flow. A water pipe of suitable diameter and material is selected and connected to the pressurized syringe to ensure a stable connection.

[0022] In a preferred embodiment, in step S2, the displacement sensor is connected to the data acquisition system and the connection is ensured to be firm. The customized pressurized syringe is connected to the test device and the connection is ensured to be firm. The digital pressure gauge is connected to the data acquisition system and the connection is ensured to be firm. The three-way valve is connected to the tested syringe and the pressurized syringe and the connection is ensured to be firm. The water pipe is connected to the pressurized syringe and the connection is ensured to be firm.

[0023] In a preferred embodiment, in step S3, LabVIEW software is selected as the data acquisition system, and the displacement sensor and the digital pressure gauge are connected to the data acquisition card. The LabVIEW software is opened, and acquisition parameters are set, including sampling frequency and data storage format.

[0024] In a preferred embodiment, in step S5, pressures of 0.1 MPa, 0.2 MPa, 0.3 MPa, 0.4 MPa, and 0.5 MPa are applied to the liquid system in sequence. The maximum displacement volume of the pressurized syringe at each pressure is recorded, and the maximum displacement volume is calculated according to the formula. A three-way valve is used to connect the syringe under test to the pressurized syringe and the pressure gauge, and the steps of applying pressure and recording data are repeated to ensure that data is recorded at each pressure point.

[0025] In a preferred embodiment, in step S6, it is also necessary to draw a pressure-compliance curve, with the applied pressure on the abscissa and the compliance on the ordinate. Observe the trend of the curve, for example, whether it is a linear relationship and whether there is an inflection point. Analyze the slope of the curve, that is, the rate at which compliance changes with pressure, and evaluate the compliance sensitivity of the syringe under test. Calculate the linearity of the curve, that is, the degree of deviation of the curve from the ideal straight line, and evaluate the compliance accuracy of the syringe under test.

[0026] In a preferred embodiment, in step S7, the test results need to be compared with the compliance data of other syringes to analyze their advantages and disadvantages.

[0027] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0028] In the present invention, by optimizing the test device, using high-precision sensors and data analysis software, an efficient, accurate and repeatable evaluation of the compliance of the syringe is achieved. This method can not only comprehensively analyze the compliance characteristics of the syringe, such as linearity, sensitivity, etc., but also guide the design of the syringe and improve the injection accuracy and injection speed. In addition, there is no need to disassemble the pressurized syringe every time, and through the displacement sensor and the customized pressurized syringe, the displacement of the pressurized syringe can be easily obtained after calculation, which greatly solves the error caused by the reading and reduces the unnecessary steps in the experiment. This method can also be applied to a variety of syringes, providing strong support for the technological progress and development of the syringe industry. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 is a flow chart of the overall method of the present invention;

[0030] Figure 2 This is a graph showing the experimental results of the maximum displacement of liquid in the present invention. DETAILED DESCRIPTION

[0031] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0032] Reference Figure 1-2 , a test method for syringe compliance, the method comprising the following steps:

[0033] S1: Prepare the test device, clean the syringe to be tested and fill it with distilled water until the nominal capacity, ensuring that all air in the system is exhausted. Fix the syringe to be tested on the adjustable fixing plate, ensuring that the core rod is firmly clamped and cannot move in the jacket;

[0034] S2: Connect the displacement sensor to the pressurized syringe to ensure that the displacement can be accurately measured. Connect the customized pressurized syringe to the test device and ensure that it is firmly connected. Connect the digital pressure gauge to the pressurized syringe to display the applied pressure value in real time. Connect the three-way valve to the syringe under test and the pressurized syringe to control the direction of liquid flow. Connect the water pipe to the pressurized syringe and ensure that it is firmly connected;

[0035] S3: Connect the data acquisition and processing system to displacement sensors, digital pressure gauges and other equipment to collect and process data. Turn on the data acquisition and processing system and ensure that it operates normally;

[0036] S4: Set up the liquid system and use three-way valve 2 to isolate the syringe under test from the pressurized syringe and the pressure gauge. Use three-way valve 1 to fill the pressurized syringe with water; apply pressure and record the data, and use the pressurized syringe to apply the pressures given in Table 1 to the liquid system in turn. Record the maximum displacement volume of the pressurized syringe at each pressure. Use the three-way valve to connect the syringe under test to the pressurized syringe and the pressure gauge.

[0037] S5: Repeatedly use the three-way valve 1 to fill the pressurized syringe with water and note the data of the maximum displacement volume in the pressurized syringe when each test pressure is reached, and record the data to ensure that each pressure point has an experimental record;

[0038] S6: Calculate compliance. Calculate the compliance of the syringe under test at each pressure using the formula:

[0039] Compliance = (maximum displacement volume - initial volume) / pressure; where the maximum displacement volume is based on the formula:

[0040] Maximum displacement volume = π*(φ / 2) 2 *L;

[0041] The unit is mL, where φ represents the nominal inner diameter of the pressurized syringe, and L represents the displacement of the pressurized syringe during the test; the initial volume is the nominal capacity of the syringe under test. Record and analyze the compliance data at each pressure point to evaluate the compliance performance of the syringe under test;

[0042] S7: Import the test data into the data analysis software and draw the pressure-compliance curve. Analyze the curve trend and evaluate the compliance characteristics of the tested syringe;

[0043] S8: Based on the test results, discuss the impact of the compliance of the tested syringe on drug injection. Compare it with the compliance data of other syringes and analyze its advantages and disadvantages;

[0044] S9: Summarize the experimental results, draw conclusions, and make suggestions for improvement;

[0045] S10: Turn off the data acquisition and processing system. Disconnect all connections and clean up the test equipment. Turn off the data acquisition and processing system. Disconnect all connections and clean up the test equipment.

[0046] S11: Write a test report, including the test purpose, methods, results, discussion and conclusions, etc. Archive the test report, data files, test device photos and other materials, and then the entire syringe compliance test process can be completed.

[0047] In step S1, select a syringe with a nominal capacity of 5 mL to ensure that its inner diameter meets the test requirements. Use high-purity distilled water and expel the air in the syringe by multiple suctions until the syringe is filled with distilled water. Fix the syringe to be tested on an adjustable fixing plate and clamp the core rod with a special clamp to ensure that it does not move or rotate during the test. Select a displacement sensor with an accuracy of 0.01 mm and install it on the pressurized syringe to ensure that its displacement can be accurately measured.

[0048] In step S8, select a customized pressurized syringe with a nominal inner diameter of 2.5 mm and connect it to the test device to ensure a stable connection. Select a digital pressure gauge with an accuracy of 0.01 MPa and connect it to the pressurized syringe to display the applied pressure value in real time. Select a three-way valve and connect it to the tested syringe and the pressurized syringe to ensure flexible operation and accurate control of the direction of liquid flow. Select a water pipe of suitable diameter and material, connect it to the pressurized syringe, and ensure a stable connection.

[0049] In step S2, connect the displacement sensor to the data acquisition system and ensure that the connection is secure. Connect the customized pressurized syringe to the test device and ensure that the connection is secure. Connect the digital pressure gauge to the data acquisition system and ensure that the connection is secure. Connect the three-way valve to the syringe under test and the pressurized syringe and ensure that the connection is secure. Connect the water pipe to the pressurized syringe and ensure that the connection is secure.

[0050] In step S3, LabVIEW software is selected as the data acquisition system, and the displacement sensor and the digital pressure gauge are connected to the data acquisition card. The LabVIEW software is opened, and acquisition parameters are set, including sampling frequency and data storage format.

[0051] In step S5, pressures of 0.1 MPa, 0.2 MPa, 0.3 MPa, 0.4 MPa, and 0.5 MPa are applied to the liquid system in sequence. The maximum displacement volume of the pressurized syringe at each pressure is recorded, and the maximum displacement volume is calculated according to the formula. The syringe under test is connected to the pressurized syringe and the pressure gauge using a three-way valve, and the steps of applying pressure and recording data are repeated to ensure that data is recorded at each pressure point.

[0052] In step S6, it is also necessary to draw a pressure-compliance curve, with the applied pressure on the horizontal axis and the compliance on the vertical axis. Observe the trend of the curve, such as whether it is a linear relationship, whether there is an inflection point, etc. Analyze the slope of the curve, that is, the rate at which compliance changes with pressure, and evaluate the compliance sensitivity of the syringe under test. Calculate the linearity of the curve, that is, the degree of deviation of the curve from the ideal straight line, and evaluate the compliance accuracy of the syringe under test.

[0053] In step S7, the test results need to be compared with the compliance data of other syringes to analyze their advantages and disadvantages. For example, compared with metal syringes, plastic syringes are usually more compliant, but may have insufficient strength.

[0054] In the present invention, by optimizing the test device, using high-precision sensors and data analysis software, an efficient, accurate and repeatable evaluation of the compliance of the syringe is achieved. This method can not only comprehensively analyze the compliance characteristics of the syringe, such as linearity, sensitivity, etc., but also guide the design of the syringe and improve the injection accuracy and injection speed. In addition, there is no need to disassemble the pressurized syringe every time, and through the displacement sensor and the customized pressurized syringe, the displacement of the pressurized syringe can be easily obtained after calculation, which greatly solves the error caused by the reading and reduces the unnecessary steps in the experiment. This method can also be applied to a variety of syringes, providing strong support for the technological progress and development of the syringe industry.

[0055] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0056] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for testing the compliance of a syringe, characterized in that: The method comprises the following steps: S1: Prepare the test device, clean the syringe to be tested and fill it with distilled water until the nominal capacity, ensuring that all air in the system is exhausted; fix the syringe to be tested on the adjustable fixing plate, ensuring that the core rod is firmly clamped and cannot move in the jacket; S2: Connect the displacement sensor to the pressurized syringe to ensure that the displacement can be accurately measured; connect the customized pressurized syringe to the test device and ensure that it is firmly connected; connect the digital pressure gauge to the pressurized syringe to display the applied pressure value in real time; connect the three-way valve to the syringe under test and the pressurized syringe to control the direction of liquid flow; connect the water pipe to the pressurized syringe and ensure that it is firmly connected; S3: Connect the data acquisition and processing system to the displacement sensor and digital pressure gauge equipment to collect and process data; turn on the data acquisition and processing system and ensure its normal operation; S4: Establish a liquid system, use three-way valve 2 to isolate the tested syringe from the pressurized syringe and the pressure gauge; use three-way valve 1 to fill the pressurized syringe with water; apply pressure and record data, use the pressurized syringe to apply the pressures given in Table 1 to the liquid system in turn; record the maximum displacement volume of the pressurized syringe at each pressure; use the three-way valve to connect the tested syringe to the pressurized syringe and the pressure gauge; S5: Repeatedly use the three-way valve 1 to fill the pressurized syringe with water and note the data of the maximum displacement volume in the pressurized syringe when each test pressure is reached, and record the data to ensure that each pressure point has an experimental record; S6: Calculate compliance. Calculate the compliance of the syringe under test at each pressure using the formula: Compliance = (maximum displacement volume - initial volume) / pressure; where the maximum displacement volume is based on the formula: Maximum displacement volume = π*(φ / 2) 2 *L; The unit is mL, where φ represents the nominal inner diameter of the pressurized syringe, and L represents the displacement of the pressurized syringe during the test; the initial volume is the nominal capacity of the syringe under test; the compliance data at each pressure point is recorded and analyzed to evaluate the compliance performance of the syringe under test; S7: Import the test data into the data analysis software to draw the pressure-compliance curve; analyze the curve trend and evaluate the compliance characteristics of the tested syringe; S8: Based on the test results, discuss the impact of the compliance of the tested syringe on drug injection; compare with the compliance data of other syringes and analyze their advantages and disadvantages; S9: Summarize the experimental results, draw conclusions, and make suggestions for improvement; S10: Turn off the data acquisition and processing system; disconnect all connections and clean up the test device. Turn off the data acquisition and processing system; disconnect all connections and clean up the test device. S11: Write a test report, including the test purpose, methods, results, discussion and conclusions; archive the test report, data files and test device photos, and then the entire syringe compliance test process can be completed.

2. A method for testing the compliance of a syringe as claimed in claim 1, characterized in that: In the step S1, a syringe to be tested with a nominal capacity of 5 mL is selected to ensure that its inner diameter meets the test requirements; high-purity distilled water is used, and the air in the syringe is expelled by multiple suctions until the syringe is filled with distilled water; the syringe to be tested is fixed on an adjustable fixing plate, and the core rod is clamped with a special clamp to ensure that it does not move or rotate during the test; a displacement sensor with an accuracy of 0.01 mm is selected and installed on the pressurized syringe to ensure that its displacement can be accurately measured.

3. A method for testing the compliance of a syringe as claimed in claim 1, characterized in that: In the step S8, a customized pressurized syringe with a nominal inner diameter of 2.5 mm is selected and connected to the test device to ensure a stable connection; a digital pressure gauge with an accuracy of 0.01 MPa is selected and connected to the pressurized syringe to display the applied pressure value in real time; a three-way valve is selected and connected to the syringe under test and the pressurized syringe to ensure flexible operation and accurate control of the liquid flow direction; a water pipe of suitable diameter and material is selected and connected to the pressurized syringe to ensure a stable connection.

4. A method for testing the compliance of a syringe as claimed in claim 1, characterized in that: In step S2, the displacement sensor is connected to the data acquisition system and the connection is ensured to be firm; the customized pressurized syringe is connected to the test device and the connection is ensured to be firm; the digital pressure gauge is connected to the data acquisition system and the connection is ensured to be firm; the three-way valve is connected to the syringe under test and the pressurized syringe and the connection is ensured to be firm; the water pipe is connected to the pressurized syringe and the connection is ensured to be firm.

5. A syringe compliance testing method as claimed in claim 1, characterized in that: In step S3, LabVIEW software is selected as the data acquisition system, and the displacement sensor and the digital pressure gauge are connected to the data acquisition card; the LabVIEW software is opened, and acquisition parameters are set, including sampling frequency and data storage format.

6. A method for testing syringe compliance as claimed in claim 1, characterized in that: In step S5, pressures of 0.1 MPa, 0.2 MPa, 0.3 MPa, 0.4 MPa, and 0.5 MPa are applied to the liquid system in sequence; the maximum displacement volume of the pressurized syringe at each pressure is recorded, and the maximum displacement volume is calculated according to the formula; the syringe under test is connected to the pressurized syringe and the pressure gauge using a three-way valve, and the steps of applying pressure and recording data are repeated to ensure that data is recorded for each pressure point.

7. A syringe compliance testing method as claimed in claim 1, characterized in that: In the step S6, it is also necessary to draw a pressure-compliance curve, where the abscissa is the applied pressure and the ordinate is the compliance; Observe the trend of the curve, such as whether it is a linear relationship and whether there is an inflection point; analyze the slope of the curve, that is, the rate at which compliance changes with pressure, and evaluate the compliance sensitivity of the syringe under test; calculate the linearity of the curve, that is, the degree of deviation of the curve from the ideal straight line, and evaluate the compliance accuracy of the syringe under test.

8. A syringe compliance testing method as claimed in claim 1, characterized in that: In step S7, the test results need to be compared with the compliance data of other syringes to analyze their advantages and disadvantages.

Images