Product/Service

High Voltage Leak Detection (HVLD) Equipment For Parenteral And Biologic Drug Products

GettyImages-2235582019-pre-filled-syringe-production-line

Referenced in the new USP <1207> Chapter Guidance as a deterministic test method for container closure integrity testing.

PTI packaging and inspection systems revolutionized the conventional HVLD method and introduced a groundbreaking new technology for the integrity testing for all parenteral and biological products including low conductivity liquids such as sterile water for injection. This unique method known as the MicroCurrent HVLD utilizes about 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to conventional HVLD solutions.

The MicroCurrent HVLD test method is capable of detecting the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects. It assures product CCI by scanning a non-conductive sealed container with electrode probes. Any defect in the packaging results in resistance differential and change in current flow in the container as well as the approximate defect location.

Any breach in the sterile packaging systems of pharmaceutical packaging can convert a life-saving product to a life-threatening microbial soup. The MicroCurrent HVLD is a patent-pending unique high voltage leak detection technology that is found to be highly effective across applications like pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and pouches. It is also one of the most efficient online container closure testing method that needs minimal infrastructure modifications. This technology is non-invasive that requires no sample preparation. It is one of the most effective CCI technologies for all parenteral and biologic products.

PTI Packaging and Inspection Systems