New Test Method for Nondestructive Detection of Leaks in Packages by Force Decay under vacuum
1. Scope
1. Scope
1.1 Test Packages—Packages that can be non-destructively evaluated by this test method include:
1.1.1 Semi-rigid non-lidded trays.
1.1.2 Trays or cups sealed with non-porous barrier lidding material.
1.1.4 Flexible, non-porous packages
1.1 Test Packages—This standard test method provides a non-destructive means for evaluating the integrity of flexible or semi-rigid (at least one wall of the package must be more flexible than the rest), non-porous packages. The method is specifically applicable to pouches, sachets, bags, and stick packs, which are typically constructed from malleable, non-porous materials such as polymeric, foil, or laminate films. These packages commonly contain dry powders, solid components, or medical devices; however, packages filled with moist, wet, or liquid products can also be evaluated using this method.
1.2 Leaks Detected—This test method detects both gross and micron leaks by quantifying the expansive force generated by the test package within an evacuated test chamber. As test volume reduces through defects, the expansive force correspondingly diminishes or is absent. The method can discern various integrity breaches, including gross holes, micron-scale leaks, and weak seals. Hole defects of at least 20 µm. (actual sensitivity depends on package design and materials)
1.3 Test Results—The results of this test method are qualitative (Pass/Fail). Acceptance criteria are established by comparing quantitative baseline force decay measurements from control, non-leaking packages to measurements from leaking packages and packages with simulated leaks.
1.4 Units—All values stated in this standard are expressed in SI units and are to be regarded as standard.
1.5 Safety Concerns—This standard does not purport to address all potential safety concerns. It is the responsibility of the user to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 International Standardization Principles—This international standard was developed in accordance with internationally recognized principles on standardization (WTO TBT Committee).
