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Test method for sealing performance of injection vials

Date: 2021-12-22 14:18
Number of Views: 1375
Abstract: Test method for sealing performance of injection vials Abstract: the sealing leakage performance of injection vials has always been the concern of pharmaceutical manufacturers. This paper summarizes two testing methods of sealing performance, and summarizes the differences of different testing methods Key words: injection bottle, penicillin bottle, seal leakage, detection method, instrument Injection bottle (borosilicate glass or sodium calcium glass tube (Molding) injection bottle) is a small bottle with rubber plug sealing There are brown, transparent and other types, borosilicate material for the mainstream products on the market. The bottle neck is thin, and the thickness below the bottleneck is consistent The mouth of the bottle is slightly thicker than the bottle neck and slightly thinner than the bottle body Generally, vials are used for packaging vaccines, biological agents, powder injections and freeze-dried drugs. Test sample of penicillin bottle powder injection

Test method for sealing performance of injection vials


Abstract: the sealing leakage performance of injection vials has always been the concern of pharmaceutical manufacturers. This paper summarizes two testing methods of sealing performance, and summarizes the differences of different testing methods


Key words: injection bottle, penicillin bottle, seal leakage, detection method, instrument

Injection bottle (borosilicate glass or sodium calcium glass tube (Molding) injection bottle) is a small bottle with rubber plug sealing There are brown, transparent and other types, borosilicate material for the mainstream products on the market. The bottle neck is thin, and the thickness below the bottleneck is consistent The mouth of the bottle is slightly thicker than the bottle neck and slightly thinner than the bottle body Generally, vials are used for packaging vaccines, biological agents, powder injections and freeze-dried drugs.

Test sample of penicillin bottle powder injection
vials of sterile powder vial
The existing aseptic injection product packaging is mainly composed of glass vials, rubber stopper and aluminum plastic composite cover. The sealing integrity of the packaging is the basic guarantee of the contents, and is also a test item concerned by drug manufacturers. Butyl rubber stopper is the main sealing part in the bottle. At present, according to the national drug packaging material standards, there are two kinds of commonly used rubber plugs: ybb000052005 halogenated butyl rubber stopper for sterile powder for injection and ybb00052002 medical brominated butyl rubber stopper. However, there are different test methods for the sealing leakage between them and injection vials.

Ybb000052005 test method for self sealing of halogenated butyl rubber stopper for sterile powder for injection: take the sample under the item of tightness between the rubber plug and the injection vial, and use the injection needle in accordance with the puncture force determination method of rubber plug / gasket for injection (ybb00332004) * * method, puncture the rubber plug vertically at different puncture positions of the rubber plug, puncture each rubber plug 3 times, and replace the injection needle after 10 times of puncture The sample was then inverted and placed in a beaker containing 10% methylene blue solution. Put the beaker into the container of the vacuum device, vacuumize until the vacuum degree is 25kpa and maintain for 30min. The vacuum device is restored to normal pressure and maintained for 30min. Take it out and wash the bottle with water for visual observation. Methylene blue solution should not penetrate into the bottle.

Ybb000052002 medical brominated butyl rubber stopper and container tightness method: * * bottle rubber stopper: the rubber stopper to be tested shall be pretreated within 2 hours before the test: 10 rubber plugs to be tested shall be boiled in water for 5min and then taken out, and dried in 70 ℃ constant temperature drying oven for 1 h. Add half a bottle of water to each of the 10 bottles, seal the rubber plug and aluminum cap with manual capping machine, put them into the high-pressure steam * * device, 121 ℃ ± 2 ℃ for 30 minutes, take them out, cool them, and place them for 24h. Then put the stopper into a beaker containing 10g / L methylene blue solution to completely submerge it. Put the beaker into the vacuum box, vacuumize until the vacuum degree is 75kpa and maintain for 30min. The vacuum box is restored to normal pressure and maintained for 30min. Take it out and wash the bottle with water for visual observation. Methylene blue solution should not penetrate into the bottle.

Sealability detector for vials
In the above two standards, the sealing performance test method for the Xilin bottle and butyl rubber stopper is similar, both of which are vacuum method, but the vacuum conditions are different. Users should choose the corresponding test conditions according to the different types of packaging materials. Jinan Chenchi launched aseptic drug injection bottle MFY-01A Sealing tester The vacuum range of the equipment can be adjusted from - 90 kPa to 0 kPa. A special bottle pressing device is designed for the sealing test of injection vials, which can ensure that the sample is completely immersed and the test process is fully automatic and clear.

As an excellent supplier of testing instruments and testing services, Jinan Chenchi has been providing quality control solutions for the pharmaceutical industry for many years. If you have any questions about the quality control of medical rubber stopper, you are welcome to communicate with our company.


Test method for sealing performance of injection vials Test method for sealing performance of injection vials Test method for sealing performance of injection vials Test method for sealing performance of injection vials Test method for sealing performance of injection vials