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E-Scan 655 MicroCurrent High Voltage Leak Detection HVLD

PDA Universe of Pre-filled Syringe Conference, October 17-18, 2016

E-Scan 655 deterministic HVLD technology is the optimal solution for all parenteral and biologic products. 

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.

The E-Scan 655 features a fast test cycle and simple operation. Additional benefits include quick changeover and easy recipe setup to accommodate a wide range of products and applications. The offline E-Scan 655 method can be migrated from laboratory to 100% inline testing applications at high production speeds.

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
Inspection Criteria:
  • Detection of pinholes, cracks, and defective seals
  • Measures and verifies container closure system integrity