Puncture force test standard and instrument selection of various medical rubber plugs

National food and Drug Administration (SFDA) has carried out relevant regulations on the puncture performance test of butyl rubber stopper of medical rubber stopper since 2002 edition of "the standard collection of packaging materials and containers for direct contact with drugs", including puncture force, puncture debris and other indicators The medical rubber plug has excellent sealing performance and good drug resistance It is a sealing rubber plug for direct contact with drugs in the current pharmaceutical packaging industry With the popularization of the application of large infusion soft bags, the medical rubber plug butyl rubber plug is more widely used Sumspring Sanquan Zhongshi, as a provider of testing instruments and testing services, has continuously provided Zui and Zui comprehensive quality control solutions for the global pharmaceutical field for many years Ybb-01 medical packaging tear force tester developed and produced by sumspring Zhongshi is equipped with a professional puncture test device, which can be used to test the puncture performance of various pharmaceutical rubber plugs to measure the force required by the puncture device to puncture the rubber plugs The design and manufacture are all designed and manufactured in accordance with the national standards of YBB pharmaceutical packaging materials The test standard methods for puncture force of various rubber plugs are as follows: 1 Ybb00052002 rubber plugs for infusion bottles in medicinal brominated butyl rubber plugs [outer diameter 6mm, metal puncture device] take 10 rubber plugs tested and 10 rubber plugs with known puncture force and install them on the infusion bottles matched with them, and inject half bottles of water into each bottle Cover the aluminum cap, seal it with a manual capping machine, put it into a high-pressure steam sterilizer, keep it at 121 ℃± 2 ℃ for 20 minutes, lower it to room temperature, and take it out Wipe the puncture device with acetone, without damaging 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 punctured, and use the qualified metal puncture device to puncture the rubber plug alternately at the speed of (200 ± 50) mm / min according to the order that the rubber plug is tested first and then the puncture force is known Record the force applied to penetrate the plug After 10 times of puncture, replace one puncture device Until all rubber plugs are punctured once (Note: if the result of the known puncture force rubber plug is consistent with that of the previous measurement, the result of the measured rubber plug should be judged as valid, otherwise, it is invalid.) The force Zui required to puncture the tested rubber plug shall not be greater than 80N, and the average value shall not be greater than 75n During the puncture process, the rubber plug shall not be pushed into the bottle 2 Ybb00052002, 10 tested rubber plugs (the rubber plugs are all treated according to the puncture and chip dropping items and the treatment methods) are installed on the injection bottle matching with the rubber plugs [outer diameter 0.8mm, metal puncture device] for antibiotic bottles Add the aluminum cap, seal with the manual capping machine, open the puncture part of the aluminum cap, put the bottle into the puncture device, so that the center of the rubber plug can be vertically punctured, and puncture with the injection needle (0.8mm outer diameter) at the speed of (200 ± 50) mm / min Record the force exerted by penetrating the rubber plug, and repeat the puncture steps until all rubber plugs are punctured once The force required to puncture the tested rubber plug shall not exceed 10N 3 Ybb000022002 polypropylene infusion bottle [plastic puncture device] take several infusion bottles, and use the puncture device conforming to the disposable infusion device standard (gb8368-1998) to puncture the puncture part on the infusion bottle at the speed of (200 ± 50) mm / min the puncture force of the plastic puncture device shall not exceed 100N, and that of the metal puncture device shall not exceed 80N 4 Ybb00242004 (polypropylene combination cover for plastic infusion container (pull ring type) [plastic puncture device] Take 10 samples and use the plastic puncture device conforming to the disposable infusion set standard (gb8368-2998) to puncture the marked part of the combined cover gasket vertically (puncture the inner cover) at the speed of 200 mm / min ± 20 mm / min, and record the force value applied by the puncture combined cover The average puncture force shall not exceed 75 n, and the maximum value of Zui shall not exceed 80 n Sumspring Sanquan Zhongshi company specializes in the design and manufacture of yyb-01 medical packaging tear tensile tester for the pharmaceutical rubber plug industry, which is applied to a variety of bottled and bagged medical packaging materials for tension and compression test, peel strength, opening force, puncture force and other tests It is a necessary instrument for research institutions, packaging manufacturers, pharmaceutical enterprises, inspection and quarantine institutions Yyb-01 medical packaging tear force tester is equipped with different puncture devices and devices, which can meet the requirements of various standard puncture force tests such as ybb00052005, ybb00042005, ybb00332004, ybb00242004, ybb000402003, and is a good choice for pharmaceutical enterprises and testing institutions Zui For details, please consult Sheng Yongfang of Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd