E-Scan Microcurrent HVLD Albumin Case Study

This case study addresses the concern that Vacuum Decay is not a suitable test solution for detecting micro leaks in parenteral containers if the product contains large molecule or proteinaceous liquids. The study uses this demerit of vacuum decay to make the E-Scan microcurrent HVLD procedure look much batter and precise. The tests were run on 1 mL and 2.25 ml glass syringes containing either water or Albumin. The samples tested included both negative controls (non-leakers) and certified positive controls (leakers). The Vacuum Decay CCI test method shows a reduced probability in detecting positive controls containing water, and zero capability to detect positive controls with Albumin. The same sample set subjected to the E-Scan MicroCurrent HVLD technology showed nearly 100% detectability of either water or Albumin filled products.