Test method and solution of puncture force of butyl rubber plug in medicine bottle

Abstract: as the rubber stopper for glass bottles in the pharmaceutical packaging industry, the quality of "butyl rubber bottle stopper" is strictly controlled by the state As early as 2004, due to the complexity of various drug formulations and the relationship between the added concentration gradient of raw materials, and then packaged with some drugs with strong molecular activity, it is easy to have problems such as drug absorption, absorption, leaching, penetration, etc., which leads to the compatibility problem between the rubber plug and the drug After 2004, the state strictly controlled such problems, and stipulated that all pharmaceutical rubber plugs (including rubber plugs for infusion, oral liquid and other dosage forms) should stop using ordinary natural rubber plugs, and all pharmaceutical rubber plugs in pharmaceutical factories should use butyl rubber plugs So far, butyl rubber plug is also a material with high internal cleanliness, good chemical stability, air tightness and biological performance Key words: puncture device, puncture force of rubber plug, puncture force of medical rubber plug, puncture force of butyl rubber plug, puncture force strength meter, diaphragm puncture strength meter, puncture force of injection rubber plug, medical packaging performance tester testing equipment: the test sample of "med-02 medical packaging performance tester" independently developed by Jinan Saicheng: common butyl rubber plug in the market（ This sample is specially provided by Jinan Saicheng's customers) Executive Standards: ybb00052002 brominated butyl rubber stopper, ybb00332004 rubber stopper puncture and chip dropping measurement Main body: there is no small matter in the pharmaceutical industry, which is related to life safety index everywhere Butyl rubber plug, as a polymer material directly contacting with drugs, its own properties will have a direct impact on the quality of drugs Generally speaking, if the puncture force of the rubber plug is too strong, the injection will not be able to penetrate in a short time, which will affect the performance of the drug; if the puncture force of the rubber plug is too poor, it will easily lead to problems such as lax sealing; or, if the rubber plug appears debris during the puncture, it will pollute the drug, which will bring a threat to the life and safety of patients Therefore, it is essential for pharmaceutical companies to test the puncture force of butyl rubber plug, and choosing a professional instrument will directly affect the test results, and then affect the pharmaceutical company's drug sales, profits, reputation and other issues According to the national standard, the performance test of many items is usually needed for pharmaceutical packaging, and the puncture force is only one of them If the pharmaceutical enterprises are equipped with a corresponding detector for each performance test, it is not only a waste of economy, but also a waste of resources For this reason, Jinan Saicheng actively responded to the market demand and independently developed an instrument that can measure puncture force, stretching force, opening force, breaking force and other items at the same time, namely "med-02 medical packaging performance tester" The following is the whole process of puncture force performance test of butyl rubber plug, hoping to give a reference to the medical enterprises in need Test process: take 10 rubber plugs to be tested and 10 rubber plugs with known puncture force for pretreatment, and install the puncture device on the puncture device of med-02 medical packaging performance tester Place the infusion bottle directly under the puncture device to ensure that the center of the rubber plug can be punctured vertically According to the national standard, set the system parameters so that the puncture device can puncture the rubber plug alternately at the speed of 200 ± 50 mm / min according to the order of the rubber plug to be tested first and then known puncture force Set to record the force applied by penetrating the plug According to the standard, the force Zui required to puncture the tested rubber plug shall not exceed 80N, and the average value shall not exceed 75n, and no rubber plug shall be pushed into the bottle during the puncture Test results: the instrument automatically output and print, and the LCD screen displays in real time Not only the puncture force test, med-02 medical packaging performance tester is also applicable to the ampule breaking force test, syringe sliding performance, body tightness, pull-out force of rubber plug, unwinding force of tape, separation force of protective film, etc As a high-tech enterprise integrating "R & D, manufacturing, sales, training and service", Jinan Saicheng has developed nearly 100 kinds of instruments in the past ten years, which can meet customers' different performance tests of products at the same time, and is highly praised and trusted by customers For more details, please call "Jinan Saicheng technology" directly We welcome your call and look forward to sincere cooperation with you!