A rubber stopper is a commonly used accessory in pharmaceutical packaging, and is generally used with an aluminum cap. The cap of a COP vial used for biological drug packaging is the rubber stopper aluminum cap. Tightness is a very important performance of packaging, so how to detect the tightness of the rubber stopper and the container?
The tightness of the rubber stopper and the container not only requires the entire packaging system to have good performance under normal pressure, but also requires it to have good air tightness under a certain degree of vacuum to meet the storage of certain negative pressure packaging drugs need. The test method for the tightness of the rubber stopper and the container is as follows:
Take 10 of this product, put it in a beaker, add water for 5 minutes, take it out, dry at 70°C for 1 hour, and set aside. Take another 10 matched COP bottles, add water to the marked capacity, and use the above-mentioned rubber stoppers to close them, and add the matched aluminum caps to press the caps. Put it in a high-pressure steam sterilizer at 121°C±2°C, keep it for 30 minutes, cool to room temperature, and place it for 24 hours. Put the above sample upside down, put it in a co ntainer containing 10% methylene blue solution, place it in a container with an exhaust device, evacuate to a vacuum of 25KPa, maintain for 30 minutes, return the vacuum device to normal pressure, and place it for another 30 minutes. Minutes, take it out, rinse the outer wall of the bottle with water, and observe that the methylene blue solution must not penetrate into the bottle.
The detection of the adhesion between the rubber stopper of the COP vial and the container is of great significance to the safety of the use of the drug. Only by controlling this factor can the stability of the drug during the validity period be ensured.
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