In critical industries such as medical devices, pharmaceuticals, and food packaging, the integrity of packaging is paramount. The presence of leaks, allowing the infiltration of undesirable gases or harmful contaminants, can have serious consequences. This is where the ASTM F2338 standard comes into play and is referenced in ISO 11607 1.
ASTM F2338 standard
This standard provides a non-destructive test method for detecting leaks in packaging using the vacuum method. Essential for ensuring packaging consistency and integrity, it is significant in preventing contamination-related risks.
Identifying leaks
Leaks in packaging can manifest as imperfections in packaging components or at sealing joints. The vacuum method, by detecting these leaks non-destructively and without the need for additional materials, becomes an indispensable tool for maintaining quality.
Application of ASTM F2338 standard
The standard can be applied to a variety of packaging, including rigid and semi-rigid trays without a lid, trays or cups sealed with a porous lid material, non-porous rigid packaging, and non-porous flexible packaging, thus showcasing its versatility.
Leak detection process
The process involves measuring the increase in pressure (loss of vacuum) in a vacuum test chamber containing the tested packaging. This loss of vacuum indicates the presence of gas leaks from the packaging's free space or the volatilization of liquid content near the leak, with detection capabilities varying depending on the type of packaging and the nature of the leak.
Interpretation of results
The results obtained are qualitative. Acceptance or rejection criteria are based on the comparison between reference vacuum loss measurements of leak-free control packaging and those obtained with packaging exhibiting leaks or simulated leaks using a calibrated gas flow meter.
To summarize
The ASTM F2338 standard plays a fundamental role in ensuring product safety in sectors where contamination can have disastrous consequences. Its widespread adoption is recommended to ensure better quality and safety of packaging.