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Process principle of sterile sealed container leak detector
Date: 2025-09-10Read: 5
The sterile sealed container leak detector mainly achieves detection through the following process principles, and different technical methods correspond to different application scenarios:
1. Vacuum attenuation method
Place the container to be tested in a sealed testing chamber and create a pressure difference by vacuuming. Monitor the changes in vacuum inside the chamber using high-precision sensors. If there is a leak in the container, gas or liquid will diffuse into the testing chamber through the leak hole, causing abnormal fluctuations in vacuum degree. This method complies with ASTM F2338 standard and can detect leaks at the 5-micron level. It is suitable for non-destructive testing of packaging such as penicillin bottles and pre filled syringes.
2. High voltage discharge method
Apply 8-30kV high-frequency high voltage electricity to both sides of the packaging. If there are micropores in the container and the content is conductive liquid (such as injection), the current will form a short circuit through the leakage hole, and the instrument will determine the leakage through a sudden change in current. This method has a sensitivity of up to 0.2 microns and is specifically designed for detecting the electrical integrity of conductive liquids.
3. Pressure attenuation method
After inflating and pressurizing the container, monitor the rate of pressure drop, or observe the pressure rise after vacuuming the test chamber, and quantify the leakage rate through changes in pressure difference. Suitable for sealing verification of hard packaging (such as filling and capping bottles).
4. Immersion method (bubble test)
Immerse the pressurized container in water and determine the leak location by observing the bubbles. This is commonly used for laboratory validation or simple testing. This method is intuitive but cannot quantify the degree of leakage.
These technologies are centered around changes in physical pressure differentials or electrical characteristics, and use sensor signal analysis to achieve micrometer level leak detection, ensuring the safety of sterile drugs during storage and transportation.
