Inspection Methods
Vacuum Decay
Seal-Scan Technology Statement
Background
The ability to detect leaks is necessary to ensure consistency and integrity of packages. It is also important to detect leaks and defects that are not visibly detectable. Package integrity testing using destructive inspection methods such as water bath, dye tests, peel and burst tests render ALL tested packages useless, both good and bad. These methods are time consuming and unreliable, producing results that are dependent on technique, sample preparation and operator variability. In addition, destructive methods generate significant product loss, waste and mess. 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
The VeriPac leak tester connects to a test chamber that is designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The chamber is then isolated from the vacuum source and an absolute or differential vacuum transducer 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 correlate to the presence of leaks and defects within the package. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the design of the package test fixture, and critical test parameters of time and pressure.
Testing chambers can be designed to be automatic, semi-automatic or manual. This inspection method is suitable for both laboratory offline testing as well as online testing in production settings. 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 (F2338-05) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments.
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, etc.
VeriPac 225
- Leak detection for packages with defect profile >25 microns.
- Seal integrity of Tyvek®/paper lidded packages
- Absolute vacuum transducer
- Vacuum decay results measured in Mbar/sec.
VeriPac 325
- For high resolution requirements for pharmaceutical packages
- Leak detection for packages with defect profile typically >5 microns
- Micro leak detection of vials, ampoules and other rigid containers
- BPC (Bulk Pharmaceutical Chemical) and API (Active Pharmaceutical Ingredient) containers and bags
- Absolute vacuum & differential vacuum transducers
- Measures differential pressure & vacuum decay in Pa/sec.
Key Benefits of VeriPac
- Non-destructive and non-invasive
- No sample preparation
- ASTM approved test method
- FDA Recognised Consensus Standard #014; Item 168
- Allows for increased sampling
- Quantitative results
- Repeatable
- Rapid test time
- Eliminates cost and waste of destructive testing
- Test results can be easily validated
- SPC laboratory testing or online applications