Referenced in the new USP <1207> Chapter Guidance as a deterministic test method for container closure integrity testing.
MicroCurrent HVLD Technology for All Parenteral And Biologic Products
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.
Referenced in USP <1207>, PTI’s HVLDmc has proven to be a highly sensitive container closure integrity leak detection method for various types of liquid-filled packaging including, but not limited to pre-filled syringes, vials, cartridges and ampoules.
The E-Scan testing process uses a set of electrode probes to scan a non-conductive container that is sealed. The container material can be glass, plastic, or poly laminate. The container or package must contain liquid (minimum fill 30%). If a pinhole, crack, or other defect is present, there is a resistance differential and change in current flow indicating a breach in the container. The approximate defect location can be identified.
MicroCurrent HVLD can be used on a wide range of liquid based products including extremely low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.
PTI’s patent pending technology uses a unique mode of MicroCurrent HVLD, applying no more than 50% of the voltage used on conventional high voltage technologies. The MicroCurrent applied to the product during the test greatly reduces the voltage exposure to the product and environment. 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. The offline E-scan 655 method can be migrated from laboratory to 100% online testing applications at high production speeds.
- Non-destructive, non-invasive, no sample preparation
- High level of repeatability and accuracy
- Effective across all parenteral products, including extremely low conductivity liquids (WFI)
- Low voltage exposure to the product and environment
- Listed in USP Chapter <1207> as recommended method for parenteral liquid package inspection
- Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats
- Simplifies the inspection and validation process
- Offline and 100% online inspection at high production speeds