Test Laboratory

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). Leakage testing can determine whether the barrier is free of leaks and thus protects the medical products from microbial and other contamination.

What happens during a leakage test?

The integrity of the sterile barrier and primary packaging must be assessed at various stages of the life cycle. The seal integrity is checked using the dye penetration test (ASTM F1929, ASTM F3039) or visual inspection (ASTM F1886/F1886 M). ASTM F1929 is used for porous material (Tyvek/paper) and ASTM F3039 for non-porous material. Sealing channels up to 50 μm are detected.

The following methods are used to examine the integrity of the packaging, secondary packaging and sterile barrier:

Bubble test according to ASTM F2096: Detecting small damages caused by storage, transportation or the selection of unsuitable packaging with a sensitivity of 250 μm. This method can be used for almost all packaging materials and sizes.

Bubble emission test according ASTM D3078: Non-porous packaging is immersed in water and a vacuum is applied in a vacuum chamber. The vacuum is slowly increased so that the packaging expands. Leaks can thus be detected via escaping air bubbles.

Test of solid containers according to ASTM D4991: Here, the container is examined 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 the IATA P650.

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In which areas are leakage tests used?

Leakage tests are used in a wide variety of areas where sterile conditions and protection against contamination are important. These tests are particularly important in the medical and food industry.

At PAConsult, we test the integrity of the sterile barrier, especially for packaging of medical devices such as surgical instruments, endoscopes, catheters and implants.

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

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