CONTAINER CLOSURE INTEGRITY
HIGH VOLTAGE LEAK DETECTION
HVLD or High Voltage Leak Detection, is a deterministic, non-destructive leak detection method to evaluate syringes, cartridges and other liquid filled parenteral products for Container Closure Integrity.
The principle of high voltage leak detection is based on quantitative electrical conductivity measurements. The technology is simple. By passing a high-voltage probe (or brush) along the exterior of a container, a defect (as small as 1 micron!) results in an increase of recorded electrical conductivity. Robust method development and validation work allows you to easily set pass / fail criteria for your individual container closure system | package. The technology is non-destructive to the container and product – utilizing a non-contact and non-invasive method that requires no special sample preparation.
The current generation of MicroCurrent HVLD can be used with a wide range of liquid based products from low conductivity sterile water for injection (sWFI) to highly proteinaceous drug products within suspensions. In addition, MicroCurrent High Voltage Leak Detection is the only technology that does not rely on mass (helium, air or drug product) to transfer through a defect to determine leakage/integrity.
Typical High Voltage Leak Detection Applications Include:
- Pre-Filled Syringes
- Drug Product Cartridges
- Liquid Filled Vials
- Liquid Filled Pouches or Bags
- Blow-Fill-Seal (BFS) Containers
While the test method is referenced in the United States Pharmacopeia (USP) Chapter on Container Closure Integrity (CCI) – USP <1207>, perhaps the best benefit of high voltage leak detection is the platform flexibility. The technology easily scales from lab bench to 100% inline testing applications at high production speeds, ensuring product quality throughout the product lifecycle.
The experienced scientists at ZebraSCI are well versed in high voltage detection and other highly sensitive CCI methods to access injectable and parenteral packaging integrity.
Contact ZebraSci today to learn more about applications for HVLD and our other solutions for Container Closure Integrity.