The nondestructive vacuum decay test facilitates the identification of package leaks that may not be visibly detectable. We place the test package into a custom-designed test chamber and expose it to a vacuum. Sensitive pressure transducers monitor changes in the chamber pressure resulting from package headspace being drawn through any leaks present. Using acceptance criteria established through method development, our scientific experts judge the quantitative test results as pass or fail.
This type of testing is applicable to any package containing headspace, including parenteral vial packages, screw-capped bottles, auto-injectors and flexible bags or pouches. We conduct all standard vacuum decay tests in accordance with ASTM F2338-09.
We typically do not recommend vacuum decay for liquid-filled packages, as the proteinaceous product has the potential to clog and mask leaks. However, if vacuum decay is the preferred method or other methods are not feasible, we can alter the method development and validation process to accommodate liquid-filled packages.
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