Instrument: US LDA -- SIMS Model 1915+

Compliance: USP <1207>, CDE conformance evaluation

Vacuum helium detection is performed by placing a package containing helium into a customized test chamber, vacuumizing the chamber, and then analyzing the helium leakage rate from the package using helium mass spectrometry. Packaging helium leak detection technology is one of the deterministic packaging integrity detection techniques cited by THE United States Pharmacopoeia USP 1207. The detection accuracy can be less than 0.1μm of leaky hole, which is the main method to detect the maximum allowable leakage limit (MALL) of sterile product packaging.