According to ASTM F 2338-09 “Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method”
Operating on the principle of vacuum decay, this nondestructive test facilitates the identification of package leaks that may not be visibly detectable. A test package is placed into a custom-designed test chamber that is subsequently exposed to vacuum. Sensitive pressure transducers monitor changes in chamber pressure; a result of package headspace being drawn through any leaks present. Using acceptance criteria established through method development, quantitative test results may be qualitatively judged as pass or fail.
This type of testing is applicable to any package containing headspace, including, but not limited to, parenteral vial packages, screw-capped bottles, auto-injectors, and flexible bags or pouches. Vacuum decay is generally not recommended for liquid filled packages, as proteinaceous product has the potential to clog and mask leaks. However, if vacuum decay is the preferred method, or other methods are not feasible, alterations can be made to the method development and validation process to accommodate liquid filled packages.
Whitehouse Laboratories operates a “Container Testing Center of Excellence”. The entire business unit brings multiple levels of experience to each container testing program. Staff members with specific areas of expertise are always available to consult on your testing needs.