Method for detecting bacteria resistance of air-permeable packaging product

Abstract

The invention discloses a method for detecting the bacterial resistance of an air-permeable packaging product, and relates to the technical field of material detection. Comprising the following steps: selecting a plurality of test packaging bags, and sequentially carrying out a microorganism barrier test and a bubble point pressure test; counting the bubble point pressure range with the qualified rate of more than 95% in the microorganism barrier test to determine the bacteria-blocking bubble point pressure; if the bubble point pressure of the subsequent to-be-detected sample is greater than the bacterium-blocking bubble point pressure, judging that the bacterium-blocking property is unqualified, and if the bubble point pressure of the subsequent to-be-detected sample is less than the bacterium-blocking bubble point pressure, judging that the bacterium-blocking property is qualified. The correlation between the microbial barrier and the bubble point pressure is pre-established by using the sample set to determine the bacterial-blocking bubble point pressure, the bacterial-blocking bubble point pressure can be used as an index for subsequently judging whether the qualified rate of the bacterial-blocking property of a material or not, the number of samples needing to be subjected to a microbial barrier test is greatly reduced, the detection efficiency is improved, and the method is high in detection accuracy and low in cost. And the method is not limited by material types, is simple to operate, and can meet factory application requirements.

Description

Technical Field

[0001] This invention relates to the field of materials testing technology, and in particular to a method for testing the antibacterial properties of breathable packaging products. Background Technology

[0002] Medical breathable packaging products are packaging materials specifically designed for medical devices, consumables, and pharmaceuticals. They can effectively block the entry of microorganisms such as bacteria and viruses, ensuring the sterility of the products. While maintaining a sterile barrier, they allow the passage of gases (such as oxygen and carbon dioxide) and water vapor to avoid oxygen deficiency. By controlling humidity through ventilation windows or materials, they can prevent devices from getting damp or mold from growing inside the packaging, thus extending the product's shelf life.

[0003] The integrity of a packaging system is ensured by the combined antimicrobial requirements of the breathable materials and the seals. When testing the antimicrobial properties of medical breathable packaging materials, Part 10 of YY / T 0681-2011 "Test Methods for Sterile Medical Device Packaging" (specifically, Part 14) is used to assess microbial barrier performance. This standard uses aerosols or liquids for microbial challenge tests (such as Staphylococcus aureus suspension) to detect the antimicrobial properties of medical breathable packaging materials. However, this standard method requires several days for microbial culture, necessitates complex equipment to simulate conditions, has a long testing cycle, requires strict biosafety conditions, is complex to operate, and has low testing efficiency, making it unsuitable for industrial-scale testing. Summary of the Invention

[0004] This invention provides a method for testing the antimicrobial properties of breathable packaging products, addressing the technical problems of complex operation, high requirements for testing environment and equipment, and long testing cycle in current antimicrobial testing of medical breathable packaging products. It provides a simple, low-requirement, highly efficient, and highly accurate antimicrobial testing method to meet the needs of industrial applications.

[0005] To address the aforementioned technical problems, the present invention aims to provide a method for detecting the antibacterial properties of breathable packaging products, comprising the following steps: (1) Select more than 50 test packaging bag samples and conduct microbial barrier tests to determine whether the microbial barrier of the samples is qualified; (2) The test packaging bag sample was then subjected to a bubble point pressure test; (3) Statistically analyze the results of the microbial barrier test and the bubble point pressure of the tested packaging bag samples, calculate the bubble point pressure range with a microbial barrier test pass rate of more than 95%, and determine the maximum bubble point pressure within this bubble point pressure range as the antimicrobial bubble point pressure; (4) The bubble point pressure test is performed on the test packaging bag sample. If the bubble point pressure obtained by the test is greater than the antibacterial bubble point pressure, it is determined that the antibacterial performance is unqualified. If the bubble point pressure obtained by the test is less than the antibacterial bubble point pressure, it is determined that the antibacterial performance is qualified.

[0006] In this application's method for testing the antimicrobial barrier properties of breathable packaging products, the microbial barrier and bubble point pressure of multiple test packaging bags are pre-tested. A correlation between the microbial barrier and bubble point pressure is established using a large sample set, thereby determining the antimicrobial bubble point pressure of the test material. This antimicrobial bubble point pressure can then be used as an indicator to determine the material's pass rate for antimicrobial barrier properties. Since the characteristics of industrially mass-produced products have a certain degree of stability, for test samples of the same type, specification, and material, only a batch of samples needs to have its correlation established. Subsequent antimicrobial tests can be directly judged based on the antimicrobial bubble point pressure. This reduces the number of test packaging bag samples required for microbial barrier testing, saving on cumbersome testing steps and avoiding problems such as long microbial culture cycles, harsh testing environments, and waste of material resources. This testing method can establish a correlation between microbial barrier and bubble point pressure for different breathable packaging materials, is not limited by material type, and has high accuracy in detecting the antimicrobial barrier properties and integrity of packaging products, with sensitivity and specificity exceeding 90%, meeting the needs of industrial applications.

[0007] In some embodiments, in step (1), more than 100 test packaging bag samples are selected for a microbial barrier test to determine whether the microbial barrier of the samples is qualified.

[0008] In some embodiments, in step (2), the test packaging bag sample is subjected to bubble point pressure test using a bacteriostatic testing device. The bacteriostatic testing device includes a cylinder, a pressure supply device, a connecting device, and a pressure measuring device. The cylinder is open. One end of the connecting device is sealed to the pressure supply device and the pressure measuring device. The test packaging bag is sealed. The other end of the connecting device is sealed to the inside of the test packaging bag. The cylinder is filled with liquid, and the test packaging bag is immersed in the liquid in the cylinder.

[0009] In some embodiments, the pressure supply device includes a pressure relief valve, a flow control valve, and a compressed air supply system connected in sequence, wherein the pressure relief valve is sealed to the connecting device.

[0010] In some embodiments, the connection device includes a three-lumen catheter and / or a conduit.

[0011] In some embodiments, the pressure measuring device includes a pressure gauge.

[0012] In some embodiments, in step (2), one end of the connecting device of the antibacterial detection device is sealed to the inside of the test packaging bag, and the other end is sealed to the pressure measuring device and the pressure supply device respectively. The test packaging bag sample is completely immersed in the solution in the tank and left to stand for 1-10 minutes to ensure that the sample is completely wetted. Then the pressure supply device is turned on to control the compressed air to enter the inside of the test packaging bag sample. The pressure inside the test packaging bag sample is monitored in real time using the pressure measuring device. It is observed whether there are bubbles on the surface of the test packaging bag. The pressure value detected by the pressure measuring device when the first bubble is discharged is taken as the bubble point pressure of the test packaging bag sample.

[0013] In the method for testing the antibacterial properties of breathable packaging products in this application, when conducting a bubble point pressure test using an antibacterial testing device, the test packaging bag is completely immersed in the liquid. Compressed air is supplied to the inside of the test packaging bag using a pressure supply device. There is a pressure difference between the air inside the test packaging bag and the air outside the cylinder, which can apply a pressure from the inside to the outside of the test packaging bag. When a certain pressure value is reached, bubbles escape from the inside of the test packaging bag to the outside. This pressure can then be determined as the bubble point pressure of the test packaging bag. This bubble point pressure test has low requirements for equipment and environment, and is simple to operate, which can effectively improve the testing efficiency.

[0014] In some embodiments, in step (2), the test packaging bag sample is subjected to bubble point pressure test using a bacteriostatic testing device. The bacteriostatic testing device includes a cylinder, a vacuum system, and a pressure measuring device. The cylinder is enclosed and contains liquid and air. The test packaging bag is submerged in the water in the cylinder. The test packaging bag contains atmospheric pressure air. The vacuum system and the pressure measuring device are both sealed to the cylinder.

[0015] In some embodiments, the pressure measuring device includes a pressure gauge.

[0016] In some embodiments, in step (2), the test packaging bag sample is fixedly immersed in the liquid in the cylinder and left to stand for 1-10 minutes to ensure that the sample is completely wetted. The pressure measuring device and the vacuum system are respectively sealed and connected to the cylinder. The vacuum system is used to vacuum the cylinder. The pressure measuring device is used to monitor the pressure in the cylinder in real time and observe whether there are bubbles on the surface of the test packaging bag. When the first bubble is discharged, the pressure value detected by the pressure measuring device is Pb, and the bubble point pressure of the test packaging bag sample is determined to be -Pb.

[0017] In the method for testing the antibacterial properties of breathable packaging products in this application, when using an antibacterial testing device to perform a bubble point pressure test, the test packaging bag is completely immersed in the liquid. Since the cylinder is in a closed state, by evacuating the cylinder, there is a pressure difference between the air inside the test packaging bag and the air in the cylinder. This can apply a pressure from the inside out to the test packaging bag. When a certain pressure value is reached, bubbles escape from the inside of the test packaging bag to the outside. This pressure can then be determined as the bubble point pressure of the test packaging bag. This bubble point pressure test has low requirements for equipment and environment, and is simple to operate, which can effectively improve the testing efficiency.

[0018] In some embodiments, a limiting plate is detachably fixedly provided inside the cylinder, the limiting plate being located above the test packaging bag to prevent the test packaging bag from floating to the water surface.

[0019] In some embodiments, the liquid inside the cylinder is water.

[0020] In some embodiments, in step (3), the results of the microbial barrier test and the bubble point pressure of the test packaging bag sample are statistically analyzed, the bubble point pressure range with a microbial barrier test pass rate of more than 98% is calculated, and the maximum bubble point pressure within the bubble point pressure range is determined as the antimicrobial bubble point pressure.

[0021] In some embodiments, the test packaging bag is dialysis paper or flash nonwoven material.

[0022] Compared with the prior art, the present invention has the following beneficial effects: 1. In the method for detecting the antimicrobial properties of breathable packaging products in this application, a large sample set is used to establish the correlation between microbial barrier and bubble point pressure, thereby determining the antimicrobial bubble point pressure of the test material. Subsequently, the antimicrobial bubble point pressure can be directly used as an indicator to judge whether the material's antimicrobial properties are qualified. This reduces the number of test packaging bag samples that need to be tested for microbial barrier testing, avoids the problems of long microbial culture cycles and waste of material resources, and reduces the requirements for the testing environment and equipment. This method has high detection accuracy and simple operation, and can meet the needs of industrial applications.

[0023] 2. In the method for testing the antibacterial properties of breathable packaging products in this application, when using an antibacterial testing device to perform a bubble point pressure test, a pressure is applied from the inside out to the test packaging bag. When a certain pressure value is reached, bubbles escape from the inside of the test packaging bag to the outside. This pressure can then be determined as the bubble point pressure of the test packaging bag. The testing process has low requirements for equipment and environment and is simple to operate, which can effectively improve the testing efficiency. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the bubble point pressure test performed by the antibacterial detection device A of the present invention; Figure 2 This is a schematic diagram of the bubble point pressure test performed by the antibacterial detection device B of the present invention. Detailed Implementation

[0025] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0026] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0027] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0028] The antibacterial properties of the breathable packaging products in this application are tested using antibacterial testing device A, such as... Figure 1 As shown, the antibacterial testing device A includes a cylinder, a pressure supply device, a connecting device, a pressure measuring device, and a sealed test packaging bag. The cylinder is filled with water, and the test packaging bag is submerged in the water. The top of the cylinder is open, and a limiting plate is detachably and fixedly installed inside the cylinder. Fixing the limiting plate above the test packaging bag sample can prevent the test packaging bag sample from floating, so that the test packaging bag can be completely submerged in the water in the cylinder.

[0029] The connecting device includes a three-lumen conduit, one end of which is sealed to the inside of the test packaging bag, and the other end of which is connected to the pressure supply device and the detection device via a conduit.

[0030] The pressure supply device includes a pressure relief valve, a flow control valve, and a compressed air supply system connected in sequence via conduits. The pressure relief valve is sealed to a three-lumen conduit via a conduit. The pressure relief valve can open and close to control the supply of compressed air to the compressed air supply system, and the flow control valve controls the flow rate of the compressed air supplied by the compressed air supply system.

[0031] The pressure measuring device includes a pressure gauge, which is sealed to a three-lumen conduit via a conduit, and can be used to monitor the bubble point pressure inside the test packaging bag.

[0032] The method for testing the antimicrobial properties of air-permeable packaged products using antimicrobial testing device A in this application includes the following steps: (1) Select more than 50 test packaging bag samples and test them according to the standard of YY / T 0681-2011 "Test Methods for Sterile Medical Device Packaging" Part 14 on the microbial barrier test of breathable materials to determine whether the microbial barrier of the samples is qualified. (2) The test packaging bag sample was then tested for bubble point pressure using the antibacterial test device A. One end of the three-lumen tube of the antibacterial test device A was sealed to the inside of the test packaging bag, and the other end was sealed to the pressure gauge and the pressure supply device respectively. The test packaging bag sample was completely immersed in the water in the tank and left to stand for 3 minutes to ensure that the sample was completely wetted. At the same time, the limiting plate was fixed above the test packaging bag sample to prevent the sample from floating. (3) Open the pressure limiting valve of the antibacterial detection device A, use the flow control valve to control the flow rate of compressed air entering the test packaging bag sample, use the pressure gauge to monitor the pressure inside the test packaging bag sample in real time, observe whether there are bubbles on the surface of the test packaging bag, and take the pressure value detected by the pressure gauge when the first bubble is discharged as the bubble point pressure of the test packaging bag sample. (4) Statistically analyze the results of the microbial barrier test and the bubble point pressure of the tested packaging bag samples, calculate the bubble point pressure with a microbial barrier test pass rate of more than 95%, and determine it as the antimicrobial bubble point pressure; (5) The test packaging bag samples that have not undergone microbial barrier test are tested for bubble point pressure using antimicrobial testing device A. If the bubble point pressure obtained by the test is greater than the antimicrobial bubble point pressure, it is judged to be unqualified for antimicrobial properties. If the bubble point pressure obtained by the test is less than the antimicrobial bubble point pressure, it is judged to be qualified for antimicrobial properties.

[0033] This application can also use antimicrobial testing device B to test the antimicrobial properties of breathable packaging products, such as... Figure 2As shown, the antibacterial testing device B includes a cylinder, a vacuum system, a pressure measuring device, and a sealed test bag. The cylinder is sealed and contains water and some air. The test bag is submerged in the water within the cylinder and contains atmospheric pressure air. A detachable limiting plate is fixed inside the cylinder, securing the plate above the test bag sample to prevent it from floating and ensuring complete submersion of the test bag in the water. The vacuum system is sealed to the cylinder via a conduit. The pressure measuring device includes a pressure gauge, which is sealed to the inside of the cylinder via a conduit and used to monitor the pressure Pb within the cylinder.

[0034] The method for testing the antimicrobial properties of the breathable packaging product using antimicrobial testing device B includes the following steps: (1) Select more than 50 test packaging bag samples and test them according to the standard of YY / T 0681-2011 "Test Methods for Sterile Medical Device Packaging" Part 14 on the microbial barrier test of breathable materials to determine whether the microbial barrier of the samples is qualified. (2) The test packaging bag sample was then tested for bubble point pressure Pb using the antibacterial testing device B. The test packaging bag sample was completely immersed in the water in the tank and left to stand for 3 minutes to ensure that the sample was completely wetted. At the same time, the limiting plate was fixed above the test packaging bag sample to prevent the sample from floating. (3) The cylinder is vacuumed using a vacuum system. The pressure inside the cylinder is monitored in real time using a pressure gauge. It is observed whether there are bubbles on the surface of the test packaging bag. When the pressure gauge detects the first bubble, the pressure value is Pb. Then the bubble point pressure of the test packaging bag sample is -Pb. (4) Statistically analyze the results of the microbial barrier test and the bubble point pressure of the tested packaging bag samples, calculate the bubble point pressure with a microbial barrier test pass rate of more than 95%, and determine it as the antimicrobial bubble point pressure; (5) The test packaging bag samples that have not undergone microbial barrier test are tested for bubble point pressure using antimicrobial testing device B. If the bubble point pressure obtained by the test is greater than the antimicrobial bubble point pressure, it is judged as unqualified for antimicrobial performance. If the bubble point pressure obtained by the test is less than the antimicrobial bubble point pressure, it is judged as qualified for antimicrobial performance.

[0035] To further illustrate the present invention, the following detailed description is provided in conjunction with embodiments, but these should not be construed as limiting the scope of protection of the present invention. Unless otherwise specified, the raw materials used in the following embodiments and comparative examples are all commercially available, and the same raw materials were used in parallel experiments.

[0036] This application specifically selected four common medical packaging materials for antibacterial testing experiments, namely medical dialysis paper A and B, and flash evaporation nonwoven materials C and D.

[0037] Example 1 A method for testing the antibacterial properties of breathable packaging products includes the following steps: (1) Sample quantity: 100 sealed test packaging bags were selected for the experiment. The material of the test packaging bags was medical dialysis paper A. (2) Microbial barrier test: The test packaging bag samples were tested according to the standard of Part 14 of YY / T 0681-2011 "Test Methods for Sterile Medical Device Packaging" regarding the microbial barrier test of breathable materials, in order to determine whether the microbial barrier of the sample was qualified; (3) Bubble point pressure test: The same batch of test packaging bag samples were tested for bubble point pressure using antibacterial testing device A. One end of the three-lumen tube of antibacterial testing device A was sealed to the inside of the test packaging bag, and the other end was sealed to the pressure gauge and the pressure supply device respectively. The test packaging bag samples were completely immersed in the water in the tank and left to stand for 3 minutes to ensure that the samples were completely wetted. At the same time, the limiting plate was fixed above the test packaging bag samples to prevent the samples from floating. The pressure limiting valve of antibacterial testing device A was opened, and the flow control valve was used to control the flow rate of compressed air entering the test packaging bag samples. The pressure gauge was used to monitor the pressure inside the test packaging bag samples in real time and to observe whether there were bubbles on the surface of the test packaging bag. The pressure value detected by the pressure gauge when the first bubble was discharged was taken as the bubble point pressure of the test packaging bag samples. (4) Determining the antimicrobial bubble point pressure: The test data of the packaging bag samples in Example 1 are as follows: The bubble point pressure of 100 samples ranged from 0.1 to 1.5 bar; among them, there were 48 samples with a bubble point pressure < 0.3 bar, of which 47 samples were qualified for microbial barrier and 1 sample was unqualified, with a microbial barrier qualification rate of 97.9% for these 48 samples; in addition, there were 52 samples with a bubble point pressure greater than 0.3 bar, of which 2 samples were qualified for microbial barrier and 50 samples were unqualified, with a microbial barrier qualification rate of 3% for these 52 samples. Through analysis, it can be seen that when the bubble point pressure < 0.3 bar, the microbial barrier qualification rate reaches 97.9%, which meets the requirement of a high qualification rate. Therefore, the antimicrobial bubble point pressure of medical dialysis paper A material is determined to be 0.3 bar. (5) Verification test: Take 50 test packaging bag samples to be tested again and test the microbial barrier and bubble point pressure in sequence. Use antimicrobial testing device A to test the bubble point pressure. If the bubble point pressure obtained by the test is greater than the antimicrobial bubble point pressure, it is judged as unqualified in antimicrobial performance. If the bubble point pressure obtained by the test is less than the antimicrobial bubble point pressure, it is judged as qualified in antimicrobial performance. (6) Data analysis: Among the 50 samples tested, 27 samples had a bubble point pressure less than 0.3 bar, which was judged as qualified for antimicrobial properties. At the same time, 23 samples had a bubble point pressure greater than 0.3 bar, which was judged as unqualified for antimicrobial properties. Among the 50 samples tested, 25 samples passed the microbial barrier test and 25 samples failed the microbial barrier test. Among them, the bubble point pressure of 23 samples that passed the microbial barrier test and 2 samples that failed the microbial barrier test was less than 0.3 bar, which shows that the specificity of antimicrobial properties detection in this embodiment is 100% and the sensitivity is 92%.

[0038] Example 2 A method for testing the antibacterial properties of breathable packaging products includes the following steps: (1) Sample quantity: 100 sealed test packaging bags were selected for the experiment. The material of the test packaging bags was medical dialysis paper B. (2) Microbial barrier test: The test packaging bag samples were tested according to the standard of Part 14 of YY / T 0681-2011 "Test Methods for Sterile Medical Device Packaging" regarding the microbial barrier test of breathable materials, in order to determine whether the microbial barrier of the sample was qualified; (3) Bubble point pressure test: The same batch of test packaging bag samples were tested for bubble point pressure using antibacterial testing device A. One end of the three-lumen tube of antibacterial testing device A was sealed to the inside of the test packaging bag, and the other end was sealed to the pressure gauge and the pressure supply device respectively. The test packaging bag samples were completely immersed in the water in the tank and left to stand for 3 minutes to ensure that the samples were completely wetted. At the same time, the limiting plate was fixed above the test packaging bag samples to prevent the samples from floating. The pressure limiting valve of antibacterial testing device A was opened, and the flow control valve was used to control the flow rate of compressed air entering the test packaging bag samples. The pressure gauge was used to monitor the pressure inside the test packaging bag samples in real time and to observe whether there were bubbles on the surface of the test packaging bag. The pressure value detected by the pressure gauge when the first bubble was discharged was taken as the bubble point pressure of the test packaging bag samples. (4) Determining the antimicrobial bubble point pressure: The test data of the packaging bag samples in Example 2 are as follows: The bubble point pressure of 100 samples ranged from 0.1 to 1 bar; among them, there were 55 samples with a bubble point pressure < 0.25 bar, of which 53 samples were qualified for microbial barrier and 2 samples were unqualified, with a microbial barrier qualification rate of 96.4%; in addition, there were 45 samples with a bubble point pressure greater than 0.25 bar, of which 2 samples were qualified for microbial barrier and 43 samples were unqualified, with a microbial barrier qualification rate of 4%. Through analysis, it can be seen that when the bubble point pressure < 0.25 bar, the microbial barrier qualification rate reaches 96.5%, which meets the requirement of a high qualification rate. Therefore, the antimicrobial bubble point pressure of medical dialysis paper B material is determined to be 0.25 bar. (5) Verification test: Take 50 test packaging bag samples to be tested again and test the microbial barrier and bubble point pressure in sequence. Use antimicrobial testing device A to test the bubble point pressure. If the bubble point pressure obtained by the test is greater than the antimicrobial bubble point pressure, it is judged as unqualified in antimicrobial performance. If the bubble point pressure obtained by the test is less than the antimicrobial bubble point pressure, it is judged as qualified in antimicrobial performance. (6) Data analysis: Among the 50 samples tested, 23 samples had a bubble point pressure less than 0.25 bar, which was judged as qualified for antimicrobial properties. At the same time, 27 samples had a bubble point pressure greater than 0.25 bar, which was judged as unqualified for antimicrobial properties. Among the 50 samples tested, 20 samples passed the microbial barrier test and 30 samples failed the microbial barrier test. Among them, the bubble point pressure of 20 samples that passed the microbial barrier test and 3 samples that failed the microbial barrier test was less than 0.25 bar, which shows that the specificity of antimicrobial properties detection in this embodiment is 100% and the sensitivity is 90%.

[0039] Example 3 A method for testing the antibacterial properties of breathable packaging products includes the following steps: (1) Sample quantity: 100 sealed test packaging bags were selected for the experiment. The material of the test packaging bags was flash-processed nonwoven material C. (2) Microbial barrier test: The test packaging bag samples were tested according to the standard of Part 14 of YY / T 0681-2011 "Test Methods for Sterile Medical Device Packaging" regarding the microbial barrier test of breathable materials, in order to determine whether the microbial barrier of the sample was qualified; (3) Bubble point pressure test: The same batch of test packaging bag samples were tested for bubble point pressure using antibacterial testing device A. One end of the three-lumen tube of antibacterial testing device A was sealed to the inside of the test packaging bag, and the other end was sealed to the pressure gauge and the pressure supply device respectively. The test packaging bag samples were completely immersed in the water in the tank and left to stand for 3 minutes to ensure that the samples were completely wetted. At the same time, the limiting plate was fixed above the test packaging bag samples to prevent the samples from floating. The pressure limiting valve of antibacterial testing device A was opened, and the flow control valve was used to control the flow rate of compressed air entering the test packaging bag samples. The pressure gauge was used to monitor the pressure inside the test packaging bag samples in real time and to observe whether there were bubbles on the surface of the test packaging bag. The pressure value detected by the pressure gauge when the first bubble was discharged was taken as the bubble point pressure of the test packaging bag samples. (4) Determining the antimicrobial bubble point pressure: The test data of the packaging bag samples in Example 3 are as follows: The bubble point pressure of 100 samples ranged from 0.1 to 4 bar; among them, there were 55 samples with a bubble point pressure < 2 bar, of which 53 samples were qualified for microbial barrier and 2 samples were unqualified, with a microbial barrier qualification rate of 96.4% for these 55 samples; in addition, there were 45 samples with a bubble point pressure greater than 0.25 bar, of which 1 sample was qualified for microbial barrier and 44 samples were unqualified, with a microbial barrier qualification rate of 2% for these 45 samples. Through analysis, it can be seen that when the bubble point pressure is < 2 bar, the microbial barrier qualification rate reaches 96.4%, which meets the requirement of a high qualification rate. Therefore, the antimicrobial bubble point pressure of flash-evaporated nonwoven material C is determined to be 2 bar. (5) Verification test: Take 50 test packaging bag samples to be tested again and test the microbial barrier and bubble point pressure in sequence. Use antimicrobial testing device A to test the bubble point pressure. If the bubble point pressure obtained by the test is greater than the antimicrobial bubble point pressure, it is judged as unqualified in antimicrobial performance. If the bubble point pressure obtained by the test is less than the antimicrobial bubble point pressure, it is judged as qualified in antimicrobial performance. (6) Data analysis: Among the 50 samples tested, 18 samples had a bubble point pressure of less than 2 bar, which was judged as qualified for antimicrobial properties. At the same time, 32 samples had a bubble point pressure of greater than 2 bar, which was judged as unqualified for antimicrobial properties. Among the 50 samples tested, 18 samples passed the microbial barrier test and 32 samples failed the microbial barrier test. Among them, the bubble point pressure of the 18 samples that passed the microbial barrier test was less than 2 bar, which means that the specificity and sensitivity of the antimicrobial property detection in this embodiment are 100% and 100% respectively.

[0040] Example 4 A method for testing the antibacterial properties of breathable packaging products includes the following steps: (1) Sample quantity: 100 sealed test packaging bags were selected for the experiment. The material of the test packaging bags was flash-processed nonwoven material D. (2) Microbial barrier test: The test packaging bag samples were tested according to the standard of Part 14 of YY / T 0681-2011 "Test Methods for Sterile Medical Device Packaging" regarding the microbial barrier test of breathable materials, in order to determine whether the microbial barrier of the sample was qualified; (3) Bubble point pressure test: The same batch of test packaging bag samples were tested for bubble point pressure using antibacterial testing device A. One end of the three-lumen tube of antibacterial testing device A was sealed to the inside of the test packaging bag, and the other end was sealed to the pressure gauge and the pressure supply device respectively. The test packaging bag samples were completely immersed in the water in the tank and left to stand for 3 minutes to ensure that the samples were completely wetted. At the same time, the limiting plate was fixed above the test packaging bag samples to prevent the samples from floating. The pressure limiting valve of antibacterial testing device A was opened, and the flow control valve was used to control the flow rate of compressed air entering the test packaging bag samples. The pressure gauge was used to monitor the pressure inside the test packaging bag samples in real time and to observe whether there were bubbles on the surface of the test packaging bag. The pressure value detected by the pressure gauge when the first bubble was discharged was taken as the bubble point pressure of the test packaging bag samples. (4) Determining the antimicrobial bubble point pressure: The test data of the packaging bag samples in Example 4 are as follows: The bubble point pressure of 100 samples ranged from 0.1 to 5 bar; among them, there were 62 samples with a bubble point pressure < 3 bar, of which 61 samples were qualified for microbial barrier and 1 sample was unqualified, with a microbial barrier qualification rate of 98% for these 62 samples; in addition, there were 38 samples with a bubble point pressure greater than 3 bar, of which 3 samples were qualified for microbial barrier and 35 samples were unqualified, with a microbial barrier qualification rate of 7% for these 38 samples. Through analysis, it can be seen that when the bubble point pressure is < 3 bar, the microbial barrier qualification rate reaches 98%, which meets the requirement of a high qualification rate. Therefore, the antimicrobial bubble point pressure of flash-evaporated nonwoven material D is determined to be 3 bar. (5) Verification test: Take 50 test packaging bag samples to be tested again and test the microbial barrier and bubble point pressure in sequence. Use antimicrobial testing device A to test the bubble point pressure. If the bubble point pressure obtained by the test is greater than the antimicrobial bubble point pressure, it is judged as unqualified in antimicrobial performance. If the bubble point pressure obtained by the test is less than the antimicrobial bubble point pressure, it is judged as qualified in antimicrobial performance. (6) Data analysis: Among the 50 samples tested, 15 samples had a bubble point pressure of less than 3 bar, which was judged as qualified for antimicrobial properties. At the same time, 35 samples had a bubble point pressure of greater than 3 bar, which was judged as unqualified for antimicrobial properties. Among the 50 samples tested, 15 samples passed the microbial barrier test and 35 samples failed the microbial barrier test. Among them, the bubble point pressure of the 15 samples that passed the microbial barrier test was less than 3 bar, which means that the specificity and sensitivity of the antimicrobial property detection in this embodiment are 100% and 100% respectively.

[0041] As can be seen from the experimental results of Examples 1-4 above, the bubble point pressure of four different medical breathable packaging bags can be tested according to the antimicrobial properties test method of this application, and the relationship between bubble point pressure and microbial barrier can be established. The antimicrobial properties of medical breathable packaging bags can be directly evaluated by testing the bubble point pressure of the materials. The method has been verified by independent validation set, and the accuracy of the test is extremely high, with sensitivity and specificity both exceeding 90%, which fully demonstrates the feasibility of the test method.

[0042] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of the present invention. It should be understood that the above descriptions are merely specific embodiments of the present invention and are not intended to limit the scope of protection of the present invention. In particular, it should be noted that any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention for those skilled in the art.

Claims

1. A method for testing the antibacterial properties of breathable packaging products, characterized in that, Includes the following steps: (1) Select more than 50 test packaging bag samples and conduct microbial barrier tests to determine whether the microbial barrier of the samples is qualified; (2) The test packaging bag sample was then subjected to a bubble point pressure test; (3) Statistically analyze the results of the microbial barrier test and the bubble point pressure of the tested packaging bag samples, calculate the bubble point pressure range with a microbial barrier test pass rate of more than 95%, and determine the maximum bubble point pressure within this bubble point pressure range as the antimicrobial bubble point pressure; (4) The bubble point pressure test is performed on the test packaging bag sample. If the bubble point pressure obtained by the test is greater than the antibacterial bubble point pressure, it is determined that the antibacterial performance is unqualified. If the bubble point pressure obtained by the test is less than the antibacterial bubble point pressure, it is determined that the antibacterial performance is qualified.

2. The method for detecting the antibacterial properties of breathable packaging products as described in claim 1, characterized in that, In step (2), the test packaging bag sample is subjected to bubble point pressure test using a bacteriostatic testing device. The bacteriostatic testing device includes a cylinder, a pressure supply device, a connecting device, and a pressure measuring device. The cylinder is open. One end of the connecting device is sealed to the pressure supply device and the pressure measuring device. The test packaging bag is sealed. The other end of the connecting device is sealed to the inside of the test packaging bag. The cylinder is filled with liquid, and the test packaging bag is immersed in the liquid in the cylinder.

3. The method for detecting the antibacterial properties of breathable packaging products as described in claim 2, characterized in that, The pressure supply device includes a pressure limiting valve, a flow control valve, and a compressed air supply system connected in sequence, and the pressure limiting valve is sealed to the connecting device. And / or, the connection device includes a three-lumen catheter and / or a conduit; And / or, the pressure measuring device includes a pressure gauge.

4. The method for testing the antibacterial properties of breathable packaging products as described in claim 2 or 3, characterized in that, In step (2), one end of the connecting device of the antibacterial detection device is sealed to the inside of the test packaging bag, and the other end is sealed to the pressure measuring device and the pressure supply device respectively. The test packaging bag sample is completely immersed in the solution in the tank and left to stand for 1-10 minutes to ensure that the sample is completely wetted. Then, the pressure supply device is turned on to control the compressed air to enter the inside of the test packaging bag sample. The pressure measuring device is used to monitor the pressure inside the test packaging bag sample in real time and observe whether there are bubbles on the surface of the test packaging bag. The pressure value detected by the pressure measuring device when the first bubble is discharged is taken as the bubble point pressure of the test packaging bag sample.

5. The method for testing the antibacterial properties of breathable packaging products as described in claim 1, characterized in that, In step (2), the test packaging bag sample is subjected to bubble point pressure test using a bacteriostatic testing device. The bacteriostatic testing device includes a cylinder, a vacuum system and a pressure measuring device. The cylinder is enclosed and contains liquid and air. The test packaging bag is submerged in the water in the cylinder. The test packaging bag contains atmospheric pressure air. The vacuum system and the pressure measuring device are both sealed to the cylinder.

6. The method for testing the antibacterial properties of breathable packaging products as described in claim 5, characterized in that, The pressure measuring device includes a pressure gauge.

7. The method for testing the antibacterial properties of breathable packaging products as described in claim 5, characterized in that, In step (2), the test packaging bag sample is fixedly immersed in the liquid in the cylinder and left to stand for 1-10 minutes to ensure that the sample is completely wetted. The pressure measuring device and the vacuum system are respectively sealed and connected to the cylinder. The vacuum system is used to vacuum the cylinder. The pressure measuring device is used to monitor the pressure in the cylinder in real time and observe whether there are bubbles on the surface of the test packaging bag. When the first bubble is discharged, the pressure value detected by the pressure measuring device is Pb, then the bubble point pressure of the test packaging bag sample is determined to be -Pb.

8. The method for testing the antibacterial properties of breathable packaging products as described in claim 2 or 5, characterized in that, A limiting plate is detachably and fixedly installed inside the cylinder. The limiting plate is located above the test packaging bag and is used to prevent the test packaging bag from floating to the water surface.

9. The method for testing the antibacterial properties of breathable packaging products as described in claim 2 or 5, characterized in that, The liquid inside the cylinder is water.

10. The method for detecting the antibacterial properties of breathable packaging products as described in claim 1, characterized in that, The test packaging bag is dialysis paper or flash-evaporated nonwoven material.

Images