Monitoring solution of rubber plug puncture force

Monitoring solution for puncture force of rubber stopper of multi-layer co extrusion infusion bag

release date: Source: China Packaging editor: Jinan Languang browsing times: 611 copyright and disclaimer

core tip: This paper uses the med-01 medical packaging performance tester newly developed by Jinan Languang Electromechanical Technology Co., Ltd. and refers to relevant drug packaging standards for puncture force performance monitoring, Provide technical and data reference for relevant industries

[China Packaging News] because the multi-layer coextrusion infusion bag does not use plasticizer, adhesive and other raw materials, and the material is stable, it is not easy to react with the liquid medicine, such as adsorption, dissolution and so on, so as to avoid the harm of fine particles mixed into the liquid medicine to the human body. However, whether the rubber plug used at the mouth of the infusion bag is not easy to puncture and cause scaling is a safety issue of great concern to the infusion bag manufacturers. This paper uses the med-01 pharmaceutical packaging performance tester newly developed by Jinan Languang Electromechanical Technology Co., Ltd. and refers to the relevant pharmaceutical packaging standards to monitor the puncture force performance, providing technical and data references for relevant industries

1. Detection significance

at present, infusion bags mainly use the composite film formed by coextrusion process as the packaging material, and the three-layer coextrusion composite film with polypropylene (PP) and elastic material (SEBS) as the main body and the five layer coextrusion composite film with ester copolymer, ethylene methacrylate polymer, polyethylene and modified ethylene propylene polymer as the main material structure. Such co extrusion infusion bags do not contain any plasticizers, and the export growth of China's extruder products will show a stable and progressive situation. They do not use adhesives, and only produce water and carbon dioxide oxides after waste incineration, which is green; At the same time, its inner layer is made of stable polymers such as PP and PE, which are not easy to degrade or shed foreign matters. The packaging material has no reaction with the liquid medicine, no adsorption, and no alkali precipitation of the glass bottle, which will not cause the packaging material particles to dissolve into the liquid medicine and avoid harm to human body. It is one of the safest high-quality infusion packaging materials at present

while ensuring that the material of the infusion bag itself does not dissolve particles, it is also necessary to ensure that the material of the bag mouth rubber plug used does not desquamate during the puncture process. For example, the polyisoprene rubber plug is used, which is safe and reliable when in contact with the liquid medicine. In addition, whether the puncture force required at each position of the rubber plug when punctured by the needle tip is appropriate determines the number and time of successful puncture during infusion. Generally, less puncture times and shorter puncture time can effectively prevent insoluble particles from entering the drug solution. Therefore, the monitoring of the puncture force of the rubber plug is the key quality performance of the infusion bag product. If the puncture force is too large, it will be difficult to be punctured, and the puncture times and time will be increased. If the puncture force is too large, the gelatin plug is easy to be damaged during transportation and storage

Figure 1 multi-layer co extrusion infusion bag with rubber stopper

2. Inspection basis

the puncture force of multi-layer co extrusion infusion bag can be tested according to its own material according to the method requirements of (bag) puncture force in the use adaptability test in YBB "general rules for multi-layer co extrusion infusion film and bag" or YBB "three-layer co extrusion infusion film (I), bag" or YBB "five layer co extrusion infusion film (I), bag". The above three standards have exactly the same requirements for the parameters, process and indicators of (bag) puncture force test

3. Test sample

finished product packaging of CO extrusion infusion bags of a brand of glucose injection

4. Testing equipment

in this paper, med-01 pharmaceutical packaging performance tester independently developed by Jinan Languang Electromechanical Technology Co., Ltd. and related test fixtures are used to test the puncture force of infusion bags

Figure 2 med-01 pharmaceutical packaging performance tester when conditions permit

4.1 test principle

clamp the sample between the two collets of the fixture, and the two collets make relative movement. Through the force value sensor located on the moving collet and the displacement sensor built in the machine, collect the force value changes and displacement changes during the test process, so as to calculate various mechanical property indexes of the sample

4.2 scope of application

(1) it is applicable to the testing of puncture force, heat sealing strength, tensile performance, tensile strength and deformation rate, breaking force, tear resistance, 90 degree peel, 180 degree peel, puncture force of infusion bag cover, rubber plug puncture force, ampoule breaking force, injector sliding performance, injection needle puncture force, and the matching force of injection needle base and sheath of various packaging materials

(2) after special customization or fixture, the equipment can be used to test the tearing or pulling force of soft rubber bottle stopper and oral liquid cap, the unwinding force of adhesive tape, the separation force of protective film, the pulling force of cosmetic brush and toothbrush bristles, the tearing force of sealing film, the tearing force of pants and other packaging and product performance

(3) a testing machine integrates 16 independent testing procedures, such as medical instruments, foam compression force, tension, peeling, etc., providing users with a variety of test project options. Because China's extruder products are closely linked with strategic new industries

(4) meet a number of national and international standards: GB 8808, gb/t 1040.1, gb/t 1040.2, gb/t 1040.3, gb/t 1040.4, GB, and there are multiple curve boxes in the layout, which can be arbitrarily switched/t 1040.5, gb/t 4850, gb/t 12914, gb/t 17200, gb/t 16578.1, gb/t 7122, gb/t 2790, gb/t 2791, gb/t 2792, GB 14232.1, GB 15811, gb/t 1962.1, GB 2637 GB 15810、ISO 37、ASTM E4、ASTM D882、ASTM D1938、ASTM D3330、ASTM F88、ASTM F904、QB/T 2358、QB/T 1130 、JIS P8113、YY 、YBB 、YBB 。

4.3 equipment parameters

(1) force value sensors of 50 N, 100 N, 250 N and 500 N can be selected, and the test accuracy is better than grade 0.5. This accuracy is far ahead in the industry, effectively ensuring the accuracy of the test results

(2) according to relevant standards, the equipment provides five process and return test speeds of 10 mm/min, 50 mm/min, 100 mm/min, 150 mm/min and 200 mm/min, which can be set freely according to the requirements of test standards

(3) the super long stroke of 600 mm can meet the test of materials with large deformation rate

(4) sixteen independent test procedures, force value sensors of various specifications, and tension compression bidirectional test mode can meet various test needs of users

(5) intelligent configurations such as limit protection, overload protection, and automatic return ensure the operation safety of users

(6) a testing machine integrates 16 independent testing procedures, such as medical instruments, foam compression force, tension, peeling, etc., providing users with a variety of test project options

(7) support lystemtm laboratory data sharing system, and uniformly manage test results and test reports

5. Test process

(1) take several intact infusion bags and place them in a standard environment of 23 ℃ and 50% RH

(2) set the sample width, test speed (this test is 200 20 mm/min) and other parameter information in the instrument system

(3) install the metal puncture device that meets the standard of disposable infusion set (GB) on the moving chuck of med-01 pharmaceutical packaging performance tester

(4) fix the mouth of the infusion bag with a special fixture, so that the part of the bag mouth rubber plug to be punctured is aligned with the needle of the puncture device

(5) click the start test button, and after the puncture device punctures the rubber plug at a fixed speed, the test ends, and the instrument automatically displays the maximum puncture force value

Figure 3 test process diagram

(6) repeat the test operations of (3) ~ (5) until all samples are tested

6. Test results

the average puncture force of the multi-layer co extrusion infusion bag tested in this paper is 74.1 n, which meets the product requirements that the puncture force of the metal puncture device in the YBB series standards for multi-layer co extrusion infusion bags should not exceed 80 n

7. Conclusion

whether the rubber plug at the mouth of multi-layer coextrusion infusion bags is easy to puncture and prevent the rubber plug particles from falling into the liquid medicine is an important indicator of the safety and applicability of infusion bag packaging. Med-01 pharmaceutical packaging performance tester developed by Labthink blue light can effectively monitor the puncture force of infusion bags and obtain accurate and stable test data. Labthink Languang is always committed to providing professional testing equipment and services for customers around the world, including testing equipment and services related to barrier performance, physical and mechanical performance, sanitary performance and other categories of pharmaceutical packaging. You can log in for detailed investigation or call directly for consultation. The more you understand, the more you trust! Labthink Languang looks forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry