Leakage Test

What is the goal of a leakage test?

The aim of a leakage test is to test sterile barriers and other packaging for leaks or other defects. An intact sterile barrier is crucial to ensure the sterility of the medical product contained in the packaging during the entire life cycle (transportation and storage). This medical device test can be used to determine whether the barrier is free of leaks and thus protects the medical devices from germs and other contamination.

What happens during a leakage test?

The integrity of the sterile barrier and primary packaging of medical devices must be evaluated at different stages of the lifecycle. Seal seam integrity is checked using the Dye Penetration Test (ASTM F1929, ASTM F3039) or visual inspection (ASTM F1886/F1886 M). For porous materials (Tyvek/paper), ASTM F1929 is used, and for non-porous materials, ASTM F3039 is used. Seal channels down to 50 μm can be detected.

To check the integrity of the packaging, secondary packaging, and the sterile barrier, the following methods are used:

Bubble Test per ASTM F2096Detection of minor damage caused by storage, transport, or unsuitable packaging, with a sensitivity of 250 μm. This method is applicable to almost all materials and sizes of packaging.

Bubble Emission Test according to ASTM D3078Immerse non-porous packaging in water and create a vacuum in a vacuum chamber. The vacuum is slowly increased, causing the packaging to expand, to detect leaks via escaping air bubbles.

Testing of rigid containers according to ASTM D4991Examination of the containers for escaping air bubbles in an ethylene glycol-water mixture in a vacuum chamber. This test, with a pressure difference of 95kPa, is part of IATA P650.

In which areas are leakage tests used?

Integrity tests are used in a wide variety of fields where sterile conditions and protection from contamination are important. These tests are particularly crucial in the medical and food industries.

At PAConsult, we test packaging integrity, particularly within the scope of validations according to DIN EN ISO 11607-1 for sterile medical devices such as surgical instruments, endoscopes, catheters, and implants.

Standards: ASTM F1929, ASTM F3039, ASTM F2096, ASTM D3078, ASTM D4991, ASTM F1886/F1886M