Puncture force test standard for medical rubber stopper and test instrument used

The State Food and Drug Administration has issued relevant regulations on the puncture performance test of medicinal rubber plugs since the 2002 edition of the "Compilation of Packaging Materials and Containers for Direct Contact with Drugs". Specific tests include puncture force and puncture and chipping. . The medical rubber stopper has excellent sealing performance and good chemical resistance. It is the only sealing rubber plug for direct contact with the glass bottle in the current pharmaceutical packaging industry, and the popular medical rubber stopper with the application of the large infusion soft bag. Butyl rubber plugs are used more widely.

Sumspring Sanquan Zhongshi, as an excellent provider of testing instruments and inspection services, has been providing excellent and quality control solutions for the global pharmaceutical industry for many years. The YBB-01 medical packaging tear tester developed by Sumspring Sanquan Zhongshi is equipped with a professional puncture test device that can be used to test the puncture performance of various drugs with plastic plugs. Accurately measure the force required for the puncture to puncture the rubber plug. . Its design and manufacture are designed and manufactured according to the national standards of YBB pharmaceutical packaging materials. The standard test methods for various rubber plug penetration forces:

1. YBB00052002 medical brominated butyl rubber stopper infusion bottle with rubber stopper [outer diameter 6mm, metal puncturing device]

Take 10 test rubber plugs and 10 rubber plugs with known puncture force respectively on the matching infusion bottle, and inject half a bottle of water into each bottle. The aluminum cover was covered, sealed with a manual capping machine, placed in a high-pressure steam sterilizer at 121 ° C ± 2 ° C for 20 min, cooled to room temperature, and taken out. Wipe the puncture device with acetone, can not destroy the sharpness of the needle tip, install the puncture device on the puncture device, put the bottle into the puncture device, so that the center of the rubber plug can be vertically pierced, and use the metal puncture device that meets the requirements (200±50 ) The speed of mm/min is alternately punctured in the order of the rubber plug and the known puncture rubber plug. Record the force applied by the piercing rubber plug. After the puncture device is punctured 10 times, replace a puncture device. Until all the rubber plugs are punctured once. (Note: If the result of the puncture plug is known to be consistent with the previously measured result, then the result measured by the tested plug is valid, otherwise it is invalid.) The force required to puncture the tested plug The zui should not exceed 80N, the average value should not exceed 75N, and no rubber plug should be pushed into the bottle during the puncture.

2. YBB00052002 medicinal brominated butyl rubber stopper antibiotic bottle rubber stopper [outer diameter 0.8mm, metal puncturing device]

Ten test rubber plugs were tested (the rubber plugs were processed and treated according to the puncture and chipping) and the corresponding injection bottle was placed. With the aluminum cover, seal with a manual capping machine, open the puncture site of the aluminum cap, put the bottle into the puncture device, so that the center of the rubber plug can be vertically puncture, with the injection needle (outer diameter 0.8mm) to (200±50) Puncture at a speed of mm/min. The force applied by the piercing rubber plug was recorded and the puncture step was repeated until all the rubber plugs were punctured once. The force required to puncture the tested rubber plug must not exceed 10N.

3.YBB00022002 polypropylene infusion bottle [plastic puncture device]

Take a few infusion bottles, puncture the puncture site on the infusion bottle at a speed of (200 ± 50) mm/min with a puncture device that meets the standard for disposable infusion sets (GB8368-1998). The puncture force of the plastic puncture device must not exceed 100N, metal puncture force must not exceed 80N.

4.YBB00242004 ( polypropylene composite cover for plastic infusion container (pull ring type) [plastic puncture device]

10 samples were taken with a plastic puncture device conforming to the disposable infusion set standard (GB8368-2998) at a speed of 200mm/min±20mm/min for vertical puncture of the combined cover gasket mark (piercing the inner cover), recording The force applied by the puncture combined cover shall not exceed 75N, and the large value of Zui shall not exceed 80N.

Sumspring Sanquan Zhongshi Company specializes in the YYB-01 medical packaging tearing force tester designed and manufactured for the medicinal rubber stopper industry. It is professionally used in various bottled and bagged medical packaging materials for tensile and compression tests, peel strength, opening force and puncture force. Wait for the test. It is an indispensable instrument for research institutions, packaging materials manufacturers, pharmaceutical companies, inspection and quarantine institutions. YYB-01 medical packaging tearing force tester is equipped with different puncture devices and devices, which can meet various standard puncture force tests such as YBB00052005, YBB00042005, YBB00332004, YBB00242004, YBB00402003, etc. It is a good choice for pharmaceutical companies and testing institutions.

For details, please contact Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd. Sheng Yongfang

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