HVLD Methodology
High Voltage Leak Detection is a standard approach for assessing container closure integrity of a nonporous package system by utilizing a high voltage leak detector system capable of inspecting liquid-filled, nonporous package systems. Leveraging electrochemical phenomena a complete inspection of a package system can reliably detect not only the presence of fluid, but also the coordinate location of a leak(s) in the package system wall.
Unlike traditional High Voltage Leak Detectors, the PTI E-Scan 655 X5 model utilizes multiple, varying voltage sources directed by two sets of electrodes which result in a highly sensitive, non-destructive test method. Driven by means of the package to be exposed only to a low current i.e., micro currents the X5 upgrade allows for a evaluation of defects in the container wall and elastomer regions such as the plunger region. Utilizing data analysis and graphical visualization, acceptance criteria are determined through out the method development process.
Due to the sophistication of this advanced technology, work to optimize parameters tailored for a specific product-package system is conducted in method development. However, with both experience and guided processes method’s experience has shown methods can confidently detect certified defects of 2μm or greater, making this one of the most sensitive CCI technologies available. This highly sensitive method even works to detect package defects clogged by product formulation, proteins, or salts which makes it a perfect fit to complement DDL’s feasibility service. Package systems that may be tested by HVLD include parenteral vials, combination products, and pre-filled cartridges with a variety of product formulation content. This should be considered, however, on a product-by-product basis.
Defects
DDL utilizes our approved vendor to fabricate laser-drilled defects at particular locations throughout a package system (ref. figure on right). Each one of these “Positive Controls” come with a certificate of calibration to not only increase traceability, but also to validate a method to a confident Limit of Detection.
Timeline
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