Solution for monitoring puncture force of multi-layer coextrusion infusion bag rubber plug

Abstract: the multi-layer co extrusion infusion bag does not use plasticizer, adhesive and other raw materials, and the material is stable and is not easy to react with the liquid medicine, such as adsorption and dissolution, so as to avoid the harm of fine particles mixed with the liquid medicine However, whether the rubber plug used in the mouth of infusion bag is easy to pierce and produce desquamation is a safety issue of great concern for infusion bag manufacturers In this paper, the med-01 medical packaging performance tester newly developed by Zui of Jinan Languang mechanical and Electrical Technology Co., Ltd is used, and the puncture force performance is monitored with reference to relevant pharmaceutical packaging standards, so as to provide technical and data reference for relevant industries Key words: multi-layer co extrusion infusion bag, rubber plug desquamation, infusion bag rubber plug, puncture force, puncture resistance, medical packaging performance tester, liquid medicine, soft plastic packaging, medical packaging 1 Currently, the infusion bag mainly uses the composite film formed by CO extrusion process as the packaging material, polypropylene (PP), elastic material (SEBS ）The three-layer coextrusion composite membrane and the five layer coextrusion composite membrane with ester copolymer, vinyl methacrylate polymer, polyethylene and modified ethylene propylene polymer as the main materials and structures were studied This kind of coextrusion infusion bag does not contain any plasticizer, does not use adhesive, and only produces water and carbon dioxide oxides after incineration It is green and environmental friendly At the same time, its inner material is PP and PE This kind of stable polymer, which is not easy to degrade or fall off foreign matters, has no reaction between the package material and the liquid medicine, no adsorption phenomenon, no alkali evolution phenomenon of glass bottle, and will not cause the package material particles to dissolve into the liquid medicine, so as to avoid harm to human body It is one of the safe infusion packaging materials for Zui at present To ensure that the infusion bag material does not dissolve particles, it is also necessary to ensure that the bag mouth rubber plug material used does not desquamate during the puncture process, such as the use of polyisoprene rubber plug, which is safe and reliable in contact with the liquid medicine In addition, whether the puncture force needed for each position of the rubber plug to be punctured by the needle tip is appropriate determines the number and time of successful puncture during infusion Generally, the less the number of punctures and the shorter the time of punctures, it can effectively prevent the 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 is easy to cause that the rubber plug is not easy to be punctured, increasing the puncture times and time If the puncture force is too large, the gelatin plug is easy to be damaged during transportation and storage Fig 1 multi layer co extrusion infusion bag with rubber plug 2 The inspection can be based on the inspection of puncture force of multi layer co extrusion infusion bag according to its own material and related "application adaptability test" in ybb00342002 "general rules for multi layer co extrusion infusion film and bag" or ybb000102005 "three layer Co extrusion infusion film (I) bag" or ybb00112005 "five layer co extrusion infusion film (I) bag" Method requirements for puncture force The above three standards have the same requirements on the parameters, process and indicators of the puncture force test 3 The packaging of the co extrusion infusion bag of a certain brand of glucose injection for the test sample 4 In this paper, the med-01 medical packaging performance tester independently developed by Jinan Languang Electromechanical Technology Co., Ltd is used to test the puncture force of infusion bag Fig 2 med-01 medical packaging performance tester 4.1 test principle: mount the sample between two collets of the fixture, and the two collets make relative motion Through the force value sensor on the moving collet and the displacement sensor built in the machine, collect the force value change and displacement change during the test, and then calculate various mechanical performance indexes of the sample 4.1 scope of application (1) it is applicable to the detection of puncture force, heat sealing strength, tensile performance, tensile strength and deformation rate, breaking force, tear resistance, 90 degree peeling, 180 degree peeling, puncture force of infusion bag cover, rubber plug puncture force, ampule breaking force, syringe sliding performance, needle puncture force, needle seat and sheath coordination force of various packaging materials (2) After special customization or fixture, the equipment can be used to test the tear or pull-out force of soft rubber bottle stopper and oral liquid cap, the unwinding force of adhesive tape, the separation force of protective film, the pull-out force of makeup brush and toothbrush brush, the tear force of sealing film, the tear force of trouser type and other packaging and product performance (3) a test machine integrates sixteen kinds of independent testing procedures, including medical apparatus, foam compression force, stretching and stripping, and provides users with many kinds of test items (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 / 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 0613-2007 、 YBB 00042002 、 YBB 00112004 。 4.3 four kinds of force value sensors with equipment parameters (1) 50 N, 100 N, 250 N and 500 N can be selected, and the test accuracy is better than level 0.5 This accuracy is the first in the industry, which effectively ensures the accuracy of the test results (2) According to the relevant standards, the equipment provides five 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 the test standards (3) The ultra long stroke of 600 mm can meet the test of materials with large deformation rate (4) Sixteen kinds of independent test procedures, various specifications of force sensors, and two-way test mode of tension and compression can meet various test needs of users (5) Intelligent configuration of limit protection, overload protection and automatic return ensures the operation safety of users (6) a test machine integrates sixteen independent testing procedures, including medical devices, foam compression force, stretching and stripping It provides users with a variety of test projects (7) supports the Lystem TM laboratory data sharing system, and uniformly manages the test results and test reports 5 During the test (1) several intact infusion bags were taken and placed under the standard environment of 23 ℃ and 50% RH (2) Parameter information such as sample width and test speed (200 ± 20 mm / min in this test) shall be set in the instrument system (3) The metal puncture device which meets the standard of disposable infusion set (GB 8368-2005) is installed on the moving chuck of med-01 medical packaging performance tester (4) Fix the opening of infusion bag with special fixture to make the part to be punctured align with the needle of puncture device (5) Click the start test button, after the puncture device penetrates the rubber plug at a fixed speed, the test is finished, and the instrument automatically displays the value of Zui large puncture force Fig 3 test process Fig (6) repeat the test operations of (3) - (5) until all samples are tested 6 The results showed that the average puncture force of the multi-layer co extrusion infusion bag tested in this paper was 74.1n, which met the product requirements of YBB series standards of multi-layer co extrusion infusion bag that "the puncture force of metal puncture device shall not exceed 80N" 7 Conclusion it is an important index for the safety and applicability of multi-layer coextrusion bag mouth rubber plug to avoid the rubber plug particles falling into the solution Med-01 medical packaging performance tester developed by Labthink blue light can effectively monitor the puncture force of infusion bag and obtain accurate and stable test data Labthink Languang has always been committed to providing professional testing equipment and services for global customers, including testing equipment and services related to pharmaceutical 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