Vacuum Decay vs. HVLDmc Test Methods
Container Closure Integrity (CCI) can be challenged using various test methods, not all of which are equally efficient in detecting leaks in the package. The two test methods for CCI commonly used for parenteral products are Vacuum Decay and High Voltage Leak Detection (HVLD). The following study highlights the CCI testing using the MicroCurrent HVLD technology, and also addresses limitations of Vacuum Decay with protein filled products, and their clogging effects.
The study was conducted with 1 ml and 2.25 ml glass syringes containing water or Albumin. The samples that were tested had both negative controls and certified positive controls. They can be recognized as non-leaky and leaky respectively. The Vacuum Decay CCI test method shows a reduced probability in detecting positive controls containing water, cannot detect positive controls with Albumin at all. The same sample set subjected to the E-Scan MicroCurrent HVLD technology resulted in nearly 100% detectability of either water or Albumin filled products.
The study infers that Vacuum Decay is not a suitable test solution for detecting micro leaks in parenteral containers if the product within has large molecule or proteinaceous liquids. On the other hand collected data from the study positively confirms that a wide range of liquid parenteral products can reliably be tested for CCI using MicroCurrent HVLD to detect micro leaks in the critical leak range.