ASTM F3287 - 17e1

Standard Test Method for Non-Destructive Detection of Leakages in Packages by Batch Extraction

Leaks in medical, pharmaceutical, or food product packages affect product quality and consumer safety. Such leaks can result from defects in the packaging material or between components designed to seal the packaging. Defects can cause unwanted gases (for example, oxygen or water vapor), particles, liquids or microbiological contaminants to enter or leave the package.

Package defect detection is a critical point in ensuring product quality and consumer safety. For sterile products, the use of a physical CCI test method can be used to ensure package sterility is maintained during shipping and product shelf life.

This method provides a non-destructive way to detect holes (leaks) in a variety of non-porous rigid and semi-rigid packages. As a result of the test, comparative quantitative flow measurement results of the sealing property of the packaging material in different material combinations and process differences are obtained.

Test procedure:

Based on detecting package leaks by measuring the mass flow out of a package while the package is inside an evacuated test chamber. The test system is a closed system during the leak measurement portion of the test cycle. The closed system consists of a vacuum reservoir, Intelligent Molecular Flow Sensor (IMFS) and vacuum test chamber.