Abstract: The anti-puncture performance of rubber stoppers for seals is an important factor affecting the ease of use. Taking a production of the sealed vial stopper, for example, use of Labthink MED-01 Pharmaceutical Packaging performance tester tested for their resistance to puncture force, and introduces the testing process, the principle of the test equipment, and so the scope of application parameters and It provides a reference for enterprises to monitor the anti-puncture performance of medical rubber stoppers.
Summary: Puncture resistance, puncture resistance, medical packaging performance tester, medical rubber stopper, gasket
1 , meaning
Medical rubber stopper is an important medical packaging material, which can be used with medical packaging or Medical Equipment such as vials, syringes, vacuum blood collection tubes, etc. Common medical rubber stopper materials include natural rubber and butyl rubber. For medical rubber plugs, due to the different molecular structure, composition and production process of the rubber plug, in addition to the safety and chemical resistance of the rubber plug, the physical and mechanical properties such as sealing performance and puncture resistance are not allowed. Neglect. If the puncture resistance of the rubber plug is too large, it is necessary to use a large force to puncture the rubber plug, which may cause the puncture needle to bend, which brings inconvenience to the medical personnel in taking medical treatment and blood drawing. In addition, if the medical rubber plug has poor puncture resistance, it is easy to generate debris after puncture, and when the debris enters the medicine, it will seriously threaten the life safety of the patient. Therefore, suitable puncture resistance and good puncture resistance are important properties that medical rubber stoppers should have.
Figure 1 various types of medical rubber stoppers
2 , test samples
A medical rubber stopper for sealing a vial produced by a company.
3 , testing basis
This paper tests the puncture resistance of the medical rubber plug (ie the puncture resistance of the rubber plug). The test process is based on the updated pharmaceutical packaging standard YBB00322004-2015 in 2015 .
4 , test equipment
The test equipment used in this test is MED-01 medical packaging performance tester, which is independently developed and produced by Jinan Languang Electromechanical Technology Co., Ltd.
Figure 2 MED-01 medical packaging performance tester and related accessories
4.1 Test principle
The puncture resistance of the medical rubber stopper refers to the value of the Zui required in the process of piercing the rubber stopper. The MED-01 medical packaging performance tester is provided with two upper and lower clamps, wherein the upper clamp can move up and down according to the set clamp separation speed, and a force value sensor is arranged, and the puncture needle is used when testing the sample's puncture resistance. Installed in the upper fixture, move downward according to the set speed, pierce the sample, and the force value sensor can test and display the force value during the puncture in real time, thus obtaining the puncture resistance of the sample. In addition, the device is also equipped with a displacement sensor, which can monitor the displacement change generated during the test in real time, and measure the deformation rate of the sample during the test, such as elongation at break.
4.2 Equipment parameters
- The test range of the device is 250 N , and it can be selectively configured with 50 N , 100 N and 500 N. The test accuracy is better than 0.5 , which effectively guarantees the accuracy of the test results.
- The device has a stroke of 600 mm .
- The equipment supports two-way test mode of tension and compression. The progress of the fixture and the return speed are available in 6 steps , which are 10 mm/min , 50 mm/min , 100 mm/min , 150 mm/min , 200 mm/ Min , 300 mm/min .
- Intelligent configuration such as limit protection, overload protection and automatic return to ensure the user's operation safety.
- A test machine integrates 16 independent test procedures such as medical instruments, foam compression, stretching, peeling and puncture resistance, providing users with a variety of test items.
- Labthink zui using a newly developed embedded computer system platform, with zui new operating software, support Lystem TM Laboratory Data Sharing System, test results and test reports unified management.
4.3 Scope of application
(1) This equipment is suitable for testing the tensile properties, tear resistance, heat seal strength, 90 degree peeling, 180 degree peeling and other properties of medical packaging bags .
(2) This equipment is suitable for rubber plug penetration force, ampoule breaking force, syringe sliding performance, syringe body tightness, needle penetration force, needle needle tube connection firmness, needle needle seat and sheath combining force , plastic blood bag pressure emptying test and other indicators test.
(3) After special modification or special accessories, the equipment can also be used for testing various performance indexes such as rubber plug pull-out force, tape unwinding force, protective film separation force, combined cover opening force and release paper separation force.
(4) This equipment complies with a number of national and international standards, such as GB 8808 , GB/T 1040.1 ~ GB/T 1040.4 , GB/T 1040.5 , GB/T 4850 , GB/T 12914 , GB/T 2790 ~ GB/T More than 30 items such as 2792 , ISO 37 , ASTM E4 , ASTM D882 , ASTM D1938 , QB/T 2358 , JIS P8113 , YY 0613 , YBB 00042002 .
5 , the test process
(1) Take 10 vials matched with the test rubber plug, add about 1/2 volume of water to the vial , and install 10 rubber plug samples on the vial after adding water.
(2) The above 10 vials were placed in a high pressure cooking pot and cooked at 121 ° C for 30 min .
(3) After the cooking is completed, the vial is taken out and cooled to room temperature.
(4) Set parameter information such as sample name, number of tests (10 times ) , test speed (200 mm/min) .
(5) Install the puncture needle in the upper clamp of the equipment, take one of the samples and fix it with the sample fixing device.
(6) Click on the test option and the test begins. The puncture needle automatically moves downward, punctures the rubber plug sample, and the device displays the force value during the puncture process in real time, and reports the zui value in the process as the puncture force.
(7) Repeat the fixed sample - test process until all 10 samples have been tested.
6 , test results
The puncture resistance of the 10 rubber plug samples tested in this paper were 26.524 N , 28.164 N , 27.649 N , 26.079 N , 27.918 N , 29.008 N , 28.417 N , 26.869 N , 29.139 N , 27.804 N , with an average of 27.757. N.
7 , conclusion
The puncture resistance is an important performance index of the medical rubber stopper, and the value of the index directly affects the performance of the medical rubber stopper. In this paper, the MED-01 medical packaging performance tester is used as the testing equipment to test the puncture resistance of the sealed rubber bottle plug produced by a certain enterprise. The test process is simple, the equipment is easy to operate, the human factor interference is less during the test, and the precision of the test result High and repeatable, it can truly reflect the puncture resistance of the tested rubber plug. Jinan Languang Electromechanical Technology Co., Ltd. is a high-tech enterprise specializing in R&D and production of packaging testing equipment. At present, it has developed a variety of different types of testing equipments covering all-round performance testing of packaging. MED-01 medical packaging performance tester only For one of them, in addition to testing the puncture resistance of medical rubber stoppers, the device can also be used for testing various properties such as tensile properties, heat seal strength, peel strength, opening force, and ampule breaking force of packaging materials. Very high cost performance. The more you understand, the more you trust! Labthink is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry!
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