Rubber stopper is one of the commonly used packaging components for penicillin bottles, oral liquid bottles, infusion bottles, etc. Due to its compatibility with drugs, the country stopped using ordinary natural rubber stoppers for all medicinal rubber stoppers until 2004, and all pharmaceutical rubber stoppers in pharmaceutical factories must use butyl rubber stoppers. The various properties of medicinal stoppers are important reference indicators that affect their quality. Among them, the puncture force of stoppers is clearly specified in the 2015 version of the drug packaging material standard, including specific test requirements and methods.
Instrument device
Material testing machine: This instrument can make the puncture device move vertically at a speed of 200mm/min ± 20mm/min, and the reaction force experienced by the puncture device during the movement can be recorded with an accuracy of ± 0.25N. There should be a suitable position in the axial direction to place the injection bottle, so that the rubber stopper mark on the injection bottle can be vertically punctured.
Injection bottle: matched with the tested rubber stopper, with a capacity of less than 50ml, 10 pieces.
Aluminum cover fire aluminum-plastic composite cover: matched with the tested rubber plug, 10 pieces.
Manual capping machine: matched with the tested rubber plug, one.
Injection needle (compliant with GB15811-2001): outer diameter 0.8mm, angled L-shaped (long), angled 12 °± 2 °, 10 pieces. Wipe with acetone or methyl isobutyl ketone before use.
The technical parameters of the material testing machine for testing the puncture force of rubber plugs are as follows:
Measurement range: 250N (other ranges are optional)
Measurement unit: N kg ib
Measurement accuracy: Level 0.5
Test stroke: ≤ 350mm
Test mode: Puncture force test
Test speed: 1-500mm/min continuously variable speed
Dimensions: 470 * 450 * 970mm
Weight: Approximately 60kg
Power supply: AC220V ± 22V, 50Hz
Unless otherwise specified, the following pre-treatment should be carried out on the rubber plugs: estimate the total surface area (Acm2) of 10 tested rubber plugs, place the rubber plugs in a suitable glass container, add water (2Aml) with twice the total surface area of the rubber plugs, boil for 5 minutes ± 15 seconds, rinse with cold water 5 times, place the washed rubber plugs into a conical flask, add water (2Aml) with twice the total surface area of the rubber plugs, cover the conical flask mouth with aluminum foil or a borosilicate beaker, heat it in a high-pressure steam sterilizer, raise the temperature to 121 ℃± 1 ℃ within 30 minutes, store it for 30 minutes, then cool it to room temperature within 30 minutes, remove it, and dry it in hot air at 60 ℃. 60 minutes, remove and store the rubber stopper in a sealed glass container for future use.
Take 10 matching injection bottles, add water of nominal capacity to each bottle, install pre treated test stoppers, add aluminum caps or aluminum-plastic combination caps, and seal with a manual capping machine. Place an injection needle on the material testing machine, insert the injection bottle into the material testing machine, open the aluminum cap or aluminum-plastic combination cap, expose the marked area of the rubber stopper, and use a puncture device to vertically puncture the marked position of the rubber stopper at a speed of 200mm/min. Record the maximum force applied to pierce through the rubber stopper. Replace the injection needle and repeat the above steps until all rubber plugs are punctured once.
The result is represented by the maximum force applied to pierce through the rubber plug.