What is the purpose of an integrity test on your product?
The purpose of an integrity test is to check sterile barriers and other packaging for leaks or other defects. An intact sterile barrier is crucial to ensuring the sterility of your medical devices contained in the packaging throughout their entire life cycle (transport and storage). The integrity test can determine whether the barrier is free of leaks, thus protecting the medical devices from microbial contamination and other contaminants.
What happens during an integrity test for your product?
The integrity of the sterile barrier and primary packaging must be assessed at various stages of the lifecycle. Seal integrity is verified using a dye penetration test (ASTM F1929, ASTM F3039) or visual inspection (ASTM F1886/F1886 M). ASTM F1929 is used for porous materials (Tyvek/paper), and ASTM F3039 for non-porous materials. Seal channels down to 50 μm are detected.
The following methods are used to verify the integrity of your packaging, secondary packaging, and sterile barrier:
Bubble test according to ASTM F2096: Determines the smallest damage caused by storage, transport, or unsuitable packaging, with a sensitivity of 250 μm. This method is applicable to almost all packaging materials and sizes.
Bubble Emission Test according to ASTM D3078: Immersing non-porous packaging under water and creating a vacuum in a vacuum chamber. The vacuum is gradually increased so that the packaging expands, detecting leaks via escaping air bubbles.
Inspection of rigid containers according to ASTM D4991: Examination of containers for escaping air bubbles in an ethylene glycol-water mixture in a vacuum chamber. This test, with a pressure difference of 95 kPa, is part of IATA P650.
In which areas is integrity testing used?
Integrity testing is 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 industries.
At PAConsult Swiss, we test the integrity of packaging, particularly as part of validations according to DIN EN ISO 11607-1 for sterile medical devices such as surgical instruments, endoscopes, catheters, and implants.
Normen: ASTM F1929, ASTM F3039, ASTM F2096, ASTM D3078, ASTM D4991, ASTM F1886/F1886M
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Johannes Lüttmann
