Medical devices and pharmaceuticals products are manufactured with zero tolerance to defects. For this reason, manufacturers give top priority to quality control procedures and regulatory standards. This is to make sure that products maintain the quality standards required for their intended use.
Packaging plays an important role in maintaining product quality and ensuring the product reaches consumers defect-free. While selecting the right packaging material is important, testing integrity of packages also holds high relevance. Traditionally, destructive testing methods like Dye Ingress and Water Bath were popular Container Closure Integrity Testing (CCIT) techniques. However, in recent years, the industry has moved towards deterministic methods to achieve more precise, reliable results.
How PTI's VeriPac Series ensure package integrity?
PTI 's VeriPac series are non-destructive, non-subjective test systems ideal for leak testing high-risk applications that require extreme levels of test reliability and accuracy. This technology uses an ASTM approved vacuum decay leak test method F2338, which is listed in ISO 11607, USP <1207>. It is an FDA recognized consensus standard for package integrity testing. Using cutting-edge innovation, VeriPac inspection systems provide repeatable, sensitive, and more robust detection of defects. VeriPac testers feature the patented PERMA-Vac manifold system and dynamic test modes that provide the ability to test a wide range of package formats including flexible, rigid and semi-rigid packaging. Apart from package integrity testing, VeriPac technology can also be used for stability studies, clinical trials, quality assurance testing and statistical process control (SPC).
The test method is initiated by connecting VeriPac leak testers to a test chamber that is specially designed to contain the package being tested. The package is placed inside the test chamber to which a vacuum is applied. Using a single or dual vacuum transducer technology, the level of vacuum as well as the change in vacuum over a predetermined test time are monitored. The variations 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.
Benefits of VeriPac series
- Deterministic, quantitative test method.
- Defect detection down to 0.034 cc/min.
- Highest level of repeatability and accuracy.
- Cost-effective with rapid return on investment.
- Simplifies the inspection and validation process
- Results proven superior to dye ingress.
- ASTM test method and FDA standard
- USP <1207> Compliant.
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