The proposed scope of the high-voltage leak detection (HVLD) is an approach for detecting the presence, and potentially the location of a leak(s) in the wall of a non-porous, rigid or flexible package containing liquid product. This method is based on quantitative electrical conductance measurements where a high voltage, micro-current signal is passed through the desired sample. When a leak path is present, a drop in the electrical resistance of the sample occurs that results in a spike in current above a predetermined pass/fail threshold. The method will demonstrate detectability in the sub 1 micron range of defect sizes and the use of liquids with conductivity between 5S (micro Siemens) and 1000S. Samples will be true cracks or laser drilled defects on two pre-selected sizes of product certified by a helium leak method (F2391-05(2016)).
Keywords-Sterile Product-Package Integrity:-Leakage:-Container closure integrity (CCI):-Seal:-Syringe:-Ampoule:-Vial:-IV Bag:
The method aims to standardize vial and syringe leak detection using HVLD. Vial and syringe leak detection is considered a high-risk concern to patients, and a standardized method is needed to assure that test methodology is properly deployed in the global pharmaceutical manufacturing environment. The standard is needed to create a method that can determine closure integrity in a wide range of defect profiles. Creating a method that can be used for low conductivity solutions, high-protein solutions, and defect detection from small (1m) to large (50m). The method will fill a void that current existing methods are not suitable for. The method will be primarily used to assure package integrity assurance within the pharmaceutical manufacturing environment.
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development