The vacuum decay leak detector is based on the vacuum decay method, and its process principle is to monitor the changes in vacuum pressure inside the testing chamber to determine whether there is a leak in the packaging. The specific process is as follows:
1. Vacuum pumping stage: Place the sample to be tested (such as penicillin bottles or ampoules) in a sealed testing chamber, start the vacuum pump to extract air from the chamber, and create a pressure difference between the inside and outside of the packaging.
2. Balance and monitoring stage: After reaching the preset vacuum degree, if there is a leak in the packaging, the internal gas or liquid will diffuse into the testing chamber through the defect, causing the pressure inside the chamber to rise.
3. Data analysis and judgment: High precision sensors record the real-time pressure change curve over time, and automatically determine the leakage amount and whether it is qualified by comparing the mathematical model with the preset threshold. This method can detect micro leaks with a minimum aperture of 1-5 μ m, meeting the requirements of international standards such as ASTM F2338 and USP 1207.
The application scope includes:
1. Pharmaceutical field:
High risk drug packaging: Non destructive sealing testing of injection and freeze-dried powder penicillin bottles to ensure the integrity of sterile barriers.
New drug delivery device: automatic injection pen, tiny leakage point recognition of pre filled needle (can detect 5 μ m leakage holes).
Other packaging forms: Sealing verification of infusion bottles, eye drops bottles, and blister packaging.
2. Medical devices and industrial fields: medical catheters, electronic component sealing testing, and precision equipment that requires high-precision leak detection.
3. Research and Aerospace: Evaluation of Sealing Systems in High Sensitivity Scenarios, Relying on Their Non Destructive and Quantitative Analysis Capability.
The core advantages of this technology lie in non-destructive testing (reusable samples after testing), high sensitivity, and intelligent judgment, significantly reducing quality inspection costs and improving reliability.
