White Paper

An Introduction To Vacuum Decay Leak Testing

By Oliver Stauffer

An Introduction To Vacuum Decay Leak Testing

Vacuum decay is a test method that has been proven over decades and improved with new technology innovations. The test method is simple in principle and challenges container integrity based on fundamental physical properties. It involves drawing vacuum on a package within a test chamber and monitoring the vacuum level for any decay, which would indicate a leak. The method established itself as a non-destructive replacement to the water bath leak test. It provides significant savings by not wasting product for a leak test, and generates return on investment in under six months for many products.

Vacuum decay has been verified that it is the most practical and sensitive vacuum based leak test method. The test measurement creates a reliable and accurate quantitative result and a pass or fail determination. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207).

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