Leak Tester and Pharmaceutical Packaging
Pharmaceutical packaging is an integral part of pharmaceutical products. The main function of drug packaging is to protect the drug, so that it can prevent the damage of biological, chemical and physical external factors during the circulation process of the drug from the factory to the consumer. It can also have the function of maintaining the stable quality of the drug itself. If the drug packaging breaks, leaks and other problems during the circulation process, then the main function of the drug packaging will lose its effect, and the drugs in the package will also have leakage, moisture, deterioration and other problems, which will have many adverse effects on the enterprise.
There are several reasons why the sealing performance of pharmaceutical packaging is not up to standard:
- The physical and mechanical properties of packaging materials such as composite film bags are not enough. During the circulation process, the packaging bags will break and the hard contents will puncture the packaging bags.
- The sealing strength of the composite film bag is not enough, mainly due to the unreasonable setting of the heat sealing parameters in the production process. If the temperature is too high, it will easily cause excessive heat sealing such as undercutting, and if the temperature is too low, there will be false sealing. Or the manufacturer itself chooses packaging materials with poor heat sealing performance.
- The torque of the bottle cap in bottle packaging is not suitable, too small torque will affect the sealing performance of the bottle cap.
The above reasons for poor sealing performance can be monitored by testing instruments such as material mechanical properties/torque.
The most commonly used method for testing leaks is ASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
By evacuating the vacuum chamber, the sample immersed in the water in the vacuum chamber will generate a pressure difference between the inside and outside, and observe whether there is gas escape in the sample. If there is no continuous bubble generation in the sample during vacuuming and vacuum holding, The airtightness of the sample is qualified. Or by evacuating the vacuum chamber to generate a pressure difference between the inside and outside of the sample, and by observing the expansion of the sample and the recovery of the shape of the sample after the vacuum is released, the sealing performance of the sample can be judged.
LT-03 leak tester is latest automatic model introduced by CELTEC.
