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Rubber stopper puncture force test

May 31,2024

Source: Link Testing Instruments Co.,Ltd.

The efficacy and quality of medicines are directly related to human health and reliability. The materials and structure of pharmaceutical packaging, especially those in direct contact with pharmaceuticals, play a decisive role in ensuring the stability of pharmaceuticals. Therefore, "Whether to choose the appropriate drug packaging materials * is an important indicator to evaluate the quality of drugs." With the continuous progress of society and the continuous improvement of scientific research, medical quality control departments pay more attention to the convenience of use and sealing integrity of halogenated butyl rubber plugs for injection. Since the rubber bottle stopper for injection needs continuous puncture and distribution by medical personnel during use, its puncture force, puncture debris, sealing and puncture properties will affect the integrity of the drug packaging and the convenience of use, so the manufacture of rubber stopper for injection is particularly important.

The characteristics of halogenated butyl rubber stopper for injection are as follows:

1. Good stability and compatibility

2. Good piercing and shattering ability

3. Excellent sealing performance;

4. Replace the isolation film rubber plug;

5. Suitable for general infusion products and therapeutic infusion products, especially for all amino acid infusion products. Butyl rubber bottle stopper has the obvious characteristics of low moisture absorption, good chemical properties, good air tightness, no physiological toxicity and side effects, and is very suitable for sealing drugs. Halogenated butyl rubber plugs for injection are mainly used to block antibiotics. When packing, the liquid medicine is injected into the container, and then sealed with halogenated butyl rubber stopper and aluminum-plastic composite cap to form a complete charge.

The rubber plug for YBB30062012 injection has the following requirements for puncture force, sealing and puncture machine retentivity:

[Puncture force] 10 pieces of this product are taken and measured according to the first method of puncture force determination of rubber stopper and gasket for injection (YBB60072012). The average puncture force shall not exceed 75N, and the puncture force of each rubber stopper shall not exceed 80N, and the rubber stopper shall not be pushed into the bottle during puncture.

[Sealing and puncture device retention] Take 10 pieces of this product and place them in a high-pressure steam sterilizer (not immersed in water), keep them at 1210C+2C for 30 minutes, cool to room temperature, take another 10 matching glass injection bottles and add water to the indicated capacity, plug them tightly with the above rubber plug, add the matching aluminum cap and gland the cap. Use the puncture device as shown in Figure 1 of the puncture force measurement method for rubber stopper and gasket for injection (YBB60072012) to puncture the puncture site of the rubber stopper vertically, Pierce the rubber stopper through the rubber stopper, hang the bottle upside down, and hang the puncture device with 0.5kg weight. The puncture device should not be pulled out for 4 hours, and the puncture site of the bottle stopper should not leak.

Automatic Tensile tester LTS-05_Adhesive Testers_Link Testing Instruments co. ,Ltd

The customized puncture force tester on LTS-05 developed and produced by Link Testing Instruments Co.Ltd. is specialized for the puncture force test of various films, composite films, battery diaphragms, artificial skin, plastic stopper for pharmaceutical packaging, combination cap, oral liquid cap and other materials. It can also be used to test the opening force of the combined lid, the breaking force of the ampoule bottle and the sliding property of the piston.

Product characteristics

Ø 7 "industrial color resistance touch screen, clear view, menu interface, sensitive touch, easy to operate

Ø Integrated puncture, stretch, peel, tear, open and other independent test procedures, providing users with a variety of test project choices

Ø The equipment supports pull and pressure two-way test mode, and the process and return speed can be adjusted arbitrarily

Ø It can be set to stop according to the test requirements through the test conditions such as force value and displacement

Ø A variety of force sensors can be configured, which provides convenience for users to test under different test conditions

Ø Professional and humanized fixture, stable and reliable, easy to operate

Ø Equipped with a micro printer, real-time printing test results

Product parameter

Sensor Specifications: 200N (standard) 30N / 50N / 100N / 500N (optional)

Force value accuracy: better than 0.5

Display resolution: 0.001N

Test speed: 400 mm (other travel can be customized)

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