MicroCurrent High Voltage Leak Detection

The latest evolution of HVLD, PTI’s patent-pending MicroCurrent High Voltage Leak Detection technology based on the conductivity based principle, aims to achieve a high level of CCI assurance across the entire range of parenteral products like vials, ampules & PFS to identify the leak Approximate hole size <1 micron.
HVLD is USP 1207 compliant as a deterministic test methodology for all liquid-filled parenteral products and replaced the traditional distractive dye ingress methods. Effective across all parenteral products, including extremely low conductivity liquids (WFI). In fact, using MicroCurrent HVLD reduces voltage exposure to the product to less than 5% of the voltage exposure experienced when testing with comparable HVLD solutions.

Specification

• Application: Non-destructive micro leak detection for parenteral products (liquid fill)
• Package Type: Vials, pre-filled syringes, cartridges
• Test Sensitivity: Approximate hole size <1 Micron (MALL)
• CFR Security Capability: Yes (21 CFR, Part 11) PTI ETHOS Software
• Test Configuration: Offline laboratory & At line inspection