Leak Detection Of Pre-Filled Syringes With Vacuum Decay Vs. HVLD Test Methods

By Oliver Stauffer

Container Closure Integrity (CCI) can be challenged using various test methods, not all of which are equally capable of detecting leaks in the package. Of the test methods listed as ‘deterministic’ in USP 1207, two methods for CCI commonly used for parenteral products are Vacuum Decay and High Voltage Leak Detection (HVLD). The following study focuses on CCI testing using the MicroCurrent HVLD technology, and tangentially addresses limitations of Vacuum Decay with protein filled products, and their clogging effects.

The study was done with 1 mL and 2.25 ml glass syringes containing either water or Albumin. The samples tested included a series of 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.

The study addresses the common 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 data further supports and 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.