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ASTM F2338: Nondestructive package leak detection via vacuum decay

The ASTM F2338 standard provides a test method for the non-destructive detection of leaks in packages using the vacuum method. This method is significant in industries such as medical devices, pharmaceuticals, and food packaging, where the ingress of unwanted gases or harmful contaminants can have severe implications.

Leaks in packages can occur as imperfections in the package components themselves or at the seal junction between mated components. The ability to detect these leaks is necessary to ensure the consistency and integrity of the packages. The vacuum method allows for the non-destructive detection of leaks that are not visually detectable, without the need for additional materials or substances such as dyes or gases.

The ASTM F2338 standard can be applied to several types of packages, including rigid and semi-rigid non-lidded trays, trays or cups sealed with porous barrier lidding material, rigid nonporous packages, and flexible nonporous packages.

The vacuum method detects package leaks by measuring the increase in pressure (vacuum loss) in an evacuated test chamber that contains the test package. The vacuum loss results from the leakage of gases from the test package's headspace or the volatilization of liquid contents located in or near the leak. The detection capabilities vary depending on the type of package and the nature of the leak.

The test results are qualitative, and the acceptance/rejection criteria are determined by comparing baseline vacuum decay measurements obtained from non-leaking control packages with measurements obtained from leaking packages, as well as measurements obtained when introducing simulated leaks using a calibrated gas flow meter.

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