Full Description

1.1This method provides a nondestructive means to detect holes (leaks) in a variety of non-porous rigid and semi-rigid packages.

1.2This test method detects package leaks by measuring the mass flow extracted from a package while the package is enclosed inside an evacuated test chamber. The test system is a closed system during the leakage measurement portion of the test cycle. The closed system includes a vacuum reservoir, Intelligent Molecular Flow Sensor (IMFS), and vacuum test chamber. Mass extracted from the test package into the vacuum test chamber flows to the vacuum reservoir through the IMFS to equalize the system. Mass flow rate from the vacuum chamber to the vacuum reservoir is measured by the IMFS. Based on the conservation of mass law, mass flow into the closed system is equal to the mass loss from the test package. The test system is capable of producing quantitative (variable data) or qualitative (pass/fail) results depending on the requirements.

1.2.1Headspace gas leakage defects equivalent to a 1m diameter glass micropipette (sharp edge defect) can be detected at a 95% confidence level.

1.2.2Liquid leakage defects equivalent to a 1m diameter glass micropipette can be detected at a 95% confidence level for glass vials and LDPE bottles. Liquid leakage defects equivalent to a 2 m diameter glass micropipette can be detected for glass syringes.

1.3Units-The values stated in SI units are to be regarded as standard. Pressure units are expressed as Pa, mbar, or Torr.

1.4This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.