Vacuum Decay Methodology
Operating on the principle of vacuum decay, the VeriPac 465 provides a level of sensitivity and accuracy that allows for the identification of submicron defects that are impossible to inspect visually. To initiate testing, a test package is placed into a custom-designed test chamber that is fabricated with material which in turn is processed in a manner that significantly decreases any noise and thus adverse effects to a test method. Each cycle exposes a vacuum while sensitive pressure transducers continuously monitor changes in chamber pressure. These pressure changes measured as a differential pressure are a result of package headspace being drawn through any defects present. Using acceptance criteria established through method development, reject references are statistically determined and subsequently validated to allow for quantitative test results which are qualitatively judged as pass or fail.
Vacuum Decay testing is applicable to any package containing headspace, including, but not limited to, parenteral vial packages, screw-capped bottles, auto-injectors, and flexible bags or pouches. With the proper experience and development process, vacuum decay can be utilized with liquid filled packages, granular, and lyophilized products.
In order to provide an optimal method consideration, the package contents must be understood to avoid adverse effects. For example, the rheology or proteinaceous concentration of a product has the potential to clog and mask leaks.
As such the Veripac 465 is one of the major technologies leveraged in DDL’s feasibility service. Accompanied by the DDL technology suite has allowed for an exhaustive approach to provide a unique solutions for evaluation of various package systems through out its life cycle. decay is the preferred method, or other methods are not feasible, alterations can be made to the method development and validation process to accommodate liquid filled packages.
DDL utilizes our approved vendor to fabricate laser-drilled defects at particular locations through a package system (ref. figure on right). Each one of these Positive Controls come with a certified calibrated certificate to not only increase traceability, but also to validate a method within a confident Limit of Detection.
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