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Maintaining the container closure integrity of vials stands as a paramount concern within pharmaceutical manufacturing, crucial for upholding product quality, efficacy, and ensuring patient safety. Conventional vial leak testing methodologies possess inherent limitations in detecting microleaks, posing a potential risk to product sterility. In response to this challenge, the advent of MicroCurrent High Voltage Leak Detection (HVLD) technology presents a groundbreaking solution, boasting unparalleled sensitivity and precision in vial leak detection.

Overview of Vial Leak Testing

Vial leak testing constitutes a pivotal stage in pharmaceutical manufacturing, serving to pinpoint any potential breaches in vial integrity that could culminate in contamination or compromise product stability. Established techniques encompass visual inspection, dye ingress and other destructive methods. Nonetheless, these methods may fall short in identifying microleaks, characterized by minute defects capable of facilitating the ingress of contaminants. Hence, manufactures are now moving towards more deterministic technology that offer quantitative and reliable test results.

Vial Leak Testing using MicroCurrent HVLD Technology

MicroCurrent HVLD is a non-destructive method for assessing the integrity of container closures in non-porous pharmaceutical and parenteral products. This technique relies on the principle of electrical current to detect any leaks in a range of liquid-filled products, including those with extremely low conductivity such as sterile water for injection (WFI) and products containing proteins or suspensions.

Compared to conventional HVLD technology, MicroCurrent HVLD significantly reduces product voltage exposure to less than 5%, thereby eliminating any potential risk to the product and reducing Ozone formation during testing.

In this method, the container is scanned using high voltage probes. One side of the container is subjected to high voltage, while a ground probe is attached to the other side. If the container is intact, both sides offer complete electrical resistance, and no significant current passes through. However, if a micro-leak or fracture is present, breakdown resistance occurs, allowing current to flow through the defect.

HVLD is unique among leak detection methods as it does not require mass to pass through the defect site; instead, it transmits electricity through the crack. This sensitivity enables HVLD to detect leaks that other conventional leak test solutions may miss.

Benefits of MicroCurrent HVLD Technology

• Scalable from the R&D Laboratory to production line
• Non-destructive, non-invasive, no sample preparation
• High level of repeatability and accuracy
• Effective across all parenteral products, including extremely low conductivity liquids (WFI)
• Lower voltage exposure produces no ozone, eliminating risk to the product and environment
• Listed in USP Chapter <1207> as recommended method for parenteral liquid package integrity testing
• Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats
• Simplifies the inspection and validation process