Vacuum Decay Technology
Vacuum decay technology is referenced in the new USP <1207> Chapter Guidance as a deterministic test method for package integrity testing.
Packages can be non-destructively evaluated using the VeriPac inspection method which is based on vacuum decay technology. Package types include filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials.
VeriPac's non-destructive technology is capable of detecting package leaks and invisible defects using an absolute or differential pressure transducer leak test system. Package leaks may appear as imperfections in the package components themselves or at the seal juncture between mated components.
Principles of VeriPac Technology
VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. The sensitivity of a test is a function of the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or automatic operation. This inspection method is suitable for laboratory offline testing and production applications for QA/QC statistical process control. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package.
VeriPac inspection systems utilize an ASTM approved vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments. Vacuum decay technology is also referenced in the new USP <1207> Chapter Guidance as a deterministic test method for package integrity testing.
The criteria for selecting the appropriate VeriPac model is based on the type of package and leak test sensitivity desired. Configurations can be optimized with either single or dual high resolution transducers as well as type of vacuum supply, i.e. internal, external, high vacuum, etc.
PTI Micro Leak Testing Featured in PDA Journal