Abstract: As the rubber plug for direct contact with glass bottles in the pharmaceutical packaging industry, the state has strict standards for the quality of "butyl rubber stoppers ". As early as 2004, due to the complexity of various drug formulations and the concentration gradient of the added raw materials, and then packaged with some drugs with strong molecular activity, it is easy to cause problems such as absorption, adsorption, leaching and infiltration of drugs. Causes the compatibility of the rubber stopper with the drug.

After 2004 , the state strictly controlled such problems, stipulated that all medicinal rubber stoppers (including rubber stoppers for infusions, oral liquids, etc.) should stop using ordinary natural rubber stoppers, and all pharmaceutical companies should use butyl rubber stoppers. Rubber stopper. Butyl rubber stopper is also a high-grade material with high internal cleanliness, good chemical stability, air tightness and biological properties.

Key words : puncture device, rubber plug puncture force, medical rubber plug puncture, butyl rubber plug puncture force, puncture strength meter, diaphragm puncture strength meter, injection rubber plug puncture force, medical packaging performance tester

Testing equipment : “ MED-02 Medical Packaging Performance Tester ” independently developed by Jinan Saicheng

Test samples : butyl rubber plugs commonly found on the market ( this sample is provided by Jinan Saicheng 's customer special )

Execution standard : YBB00052002 "Bromide butyl rubber stopper", YBB00332004 "gel plug puncture determination method"

Text : There is no small matter in the pharmaceutical industry, and it is about life safety index everywhere. As a polymer material that is directly in contact with drugs, butyl rubber plugs have their own direct effects on the quality of the drug. Generally speaking, if the puncture force of the rubber stopper is too strong, the injection cannot penetrate in a short time, thereby affecting the performance of the drug; if the puncture force of the rubber stopper is too poor, it is easy to cause problems such as poor sealing. Or, if the injection is in the case of puncture, the rubber stopper will be chipped, etc., which will contaminate the drug and threaten the patient's life.

Therefore, the detection of the puncture performance of butyl rubber plugs is indispensable for major pharmaceutical companies, and the selection of a professional instrument will directly affect the test results, and thus the pharmaceutical sales, profits, reputation, etc. of the pharmaceutical company. The series of problems has an impact.

According to national standards, pharmaceutical packaging usually requires performance testing of multiple projects, and puncture is only one of them. If the pharmaceutical company is equipped with a corresponding detector for each performance test, it is not only a waste of the economy, but also a waste of resources. To this end, Jinan Saicheng actively responded to the needs of the market, and independently developed an instrument that can measure the puncture force, stretching, opening force, breaking force and other items, namely “ MED-02 medical packaging performance test”. Instrument ."

The following is the whole process of the performance test of the butyl rubber plug puncture force, I hope to give a reference to the medical enterprises in need.

Test process :

1. 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.
2. Place the infusion bottle directly under the puncture device to ensure that the center of the gel plug can be vertically pierced.
3. According to the national standard, the system parameters are set, so that the puncture device alternately punctures the rubber plug at a speed of 200±50 mm/min according to the order of the first rubber plug and the known puncture rubber plug.
4. Set the force applied to pierce the rubber plug. According to the standard, the force required to puncture the rubber plug to be tested must not exceed 80N, the average value must not exceed 75N, and no rubber plug can be pushed into the bottle during the puncture.

Test results :

The instrument automatically outputs the print and the LCD screen displays in real time.

Not only for the puncture force test, the MED-02 medical packaging performance tester is also suitable for the ampoules breaking force test, the sliding performance of the syringe, the body tightness, the pull-out force of the rubber plug, the unwinding force of the tape, The separation force of the protective film and the like . As a high-tech enterprise integrating R&D, manufacturing, sales, training and service, Jinan Saicheng has developed nearly 100 instruments in the past ten years, which can meet the different performance tests of customers at the same time. Praise and trust. The quality of the competition, the future, more details, please call " Jinan Saicheng Technology " directly , we welcome your call, and look forward to working with you sincerely!

Veterinary medicine

Shaanxi Hongbaiyi Biotech Co., Ltd. , https://www.sxhongbaiyi.com