Vacuum decay leak testing per ASTM F2338 provides a standardized approach for performing a deterministic, non-destructive method used to evaluate the integrity of nonporous pharmaceutical packaging. The test is widely used during package development, validation, manufacturing investigations, and stability studies to detect leaks that may not be visible through traditional inspection methods.
Maintaining Container Closure Integrity (CCI) is essential for sterile pharmaceutical products. Even microscopic leaks can compromise sterility, reduce shelf life, and place patients at risk.
What is Vacuum Decay Leak Testing?
ASTM F2338, Standard Test Method for Non-Destructive Detection of Leaks in Packages by Vacuum Decay Method, establishes procedures for using vacuum decay technology to detect leaks in sealed, nonporous packages.
Unlike methods that rely on operator interpretation, vacuum decay is considered a deterministic leak detection method, meaning it directly measures physical changes caused by leakage.
Because the package remains intact after testing, manufacturers can often perform additional testing on the same sample, making vacuum decay particularly valuable during product development and validation.
How Vacuum Decay Testing Works
Vacuum decay testing measures changes in pressure inside a sealed test that is specifically designed to contain the package to be tested.
The test is performed by placing a package into the test chamber, drawing vacuum on the test chamber and monitoring it for any changes in the vacuum level.
If a package is defective, air or vapor will leak from the package into the test chamber causing a change in pressure. Non-leaking packages do not leak any air into the chamber, holding the chamber vacuum level constant. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package.
Vacuum decay testing is commonly used for a wide variety of pharmaceutical packaging formats. Our engineers work with each customer to determine whether vacuum decay testing is appropriate for their specific package design and product characteristics.
Applications for Vacuum Decay Testing
Prefilled syringes
Vials
Ampoules
Blow-fill-seal (BFS) containers
IV bags
Flexible pouches
Rigid plastic containers
Frequently asked questions
What is vacuum decay testing used for?
ASTM F2338 is used to evaluate the integrity of nonporous pharmaceutical packaging using deterministic vacuum decay technology. It helps manufacturers detect leaks without damaging the package.
Is vacuum decay a destructive test?
No. ASTM F2338 is a non-destructive test method, allowing packages to remain intact after testing so they may be used for additional evaluations when appropriate.
What packaging can be tested using vacuum decay?
The method is commonly applied to vials, prefilled syringes, IV bags, BFS containers, flexible pouches, rigid plastic containers, and other nonporous packaging systems.
Can ASTM F 2338 pinpoint where the leak is coming from?
No, it cannot pinpoint where the leak is located. It is a pass/fail test method and only tells you if a package has a leak.
Is ASTM F 2338 an FDA Consensus Standard?
The standard vacuum decay leak test method (ASTM F2338) has long been recognized by the FDA as a consensus standard for package integrity testing. The test method is also listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI – USP <1207>.