Significance and Use
5.1 Leaks in medical, pharmaceutical, or food product packages can affect product quality and consumer safety. Such leaks can arise from imperfections in package material or between mated components designed to seal the package. Defects can allow unwanted gas (e.g. oxygen or water vapor), particulates, liquids, or microbiological contaminants into or out of the package. Package defect detection can be a critical part of ensuring product quality and consumer safety. Use of a physical CCI test method for sterile products can be used to assure the stability of the package sterility property during transportation and product shelf life.
5.2 Mass extraction is a useful non-destructive test method for testing a wide variety of packages. Package shape and dimensions that can be tested using mass extraction are essentially unlimited, as long as a vacuum test chamber can be designed and manufactured to accommodate the package.
5.3 This method produces quantitative flow measurement results that are useful in comparing package sealing properties, different batches of product, material properties, and combinations of process parameters.
5.4 Applications for mass extraction range from manually loaded and operated machines to automatic unattended work cells. This method can be applied for audit testing or 100% in-line testing.
NOTE 2: Leak test methods that rely on gas or vapor transport, such as mass extraction, are not able to detect defects if they become plugged by solid or nonvolatile matter. Plugging is possible by exposure to environmental contaminants. In some cases, the packaged product itself can clog defects. For example, leak paths may become blocked by suspended solids, gelatinous matter or dried-out solutions. Product clogging propensity is a function of the product formulation, defect size and geometry, and may be linked to product storage and handling conditions as well as the time allotted to defect exposure. An investigation into the impact of repeated test condition exposure on defect plugging is recommended if product-package units are to be subject to repeated leak testing. Clogging is a complex phenomenon that is not well characterized or understood. Care must be taken to ensure that any CCI test method based on gas or vapor transport through the leak path is appropriate for the intended product.
Scope
1.1 This method provides a nondestructive means to detect holes (leaks) in a variety of non-porous rigid and semi-rigid packages.
1.2 This 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.
1.2.1 Headspace gas leakage defects equivalent to a 1µm diameter glass micropipette (sharp edge defect) can be detected at a 95% confidence level.
1.2.2 Liquid leakage defects equivalent to a 1µm diameter glass micropipette can be detected at a 95% confidence level for glass vials and LDPE bottles. Liquid leakage defects equivalent to a 2 µm diameter glass micropipette can be detected for glass syringes.
1.3 Units—The values stated in SI units are to be regarded as standard. Pressure units are expressed as Pa, mbar, or Torr.
1.4 This 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.
1.5 This 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.
