The E-Scan 655 is a revolutionary deterministic offline micro leak test instrument that utilizes a new class of HVLD technology to inspect vials, syringes, and other liquid filled parenteral products for container closure integrity. The E-Scan 655 technology is a MicroCurrent conductivity test method, HVLDmc, that is completely non-destructive to the container and product; exposing the package and product to lower voltage than other conductivity based solutions. The technology uses a non-contact and non-invasive test method that requires no sample preparation. E-Scan 655 can be used with a wide range of liquid based products including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.
Benefits - 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
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.
PTI's E-Scan 655 patent pending technology uses a unique mode of MicroCurrent HVLD,applying less than 50% of the voltage used with conventional high voltage technologies. The nature of this solution allows for testing packages with extremely low conductivity liquids such as sterile water (WFI). The MicroCurrent applied to the product during the test greatly reduces the voltage exposed to the product and environment. In fact, using PTI's MicroCurrent HVLD reduces voltage exposure to the product to less than 5% of the voltage exposure experienced when testing with comparable HVLD solutions.
MicroCurrent HVLD technology is the optimal solution for all parenteral and biologic products.
Inspection Criteria - Detection of pinholes, cracks, and defective seals - Measures and verifies container closure system integrity