Bubble Leak Package Testing

Bubble Leak Package Testing

Bubble leak testing is a method used to detect gross leaks in packaging, such as trays and pouches. It can detect defects as small as 250 microns, making it an important step in medical device packaging. Pressure is applied to the package and air bubbles indicate a breach in the sterile barrier.

To ensure consistent results, the air must be set to the same temperature. The pressure is then increased to a predetermined level, and the package is checked for leaks. If necessary, pressure can be adjusted to increase or reduce sensitivity.

Three main pieces of equipment are used for bubble leak testing: a pressure delivery system, a syringe to inject air into the package, and a container of water. The results are recorded, including the time, operator, type of package, defect size, test pressure, and the number of passes and fails.

ASTM F2096 can be used to test packages of various shapes and sizes. For headspace gas in flexible containers, ASTM D3078 is the preferred method. First, a vacuum is created, then the test specimen is poured with fluid. If no bubbles or test fluid are found, the test has been successful.