Using Microcurrent High Voltage Leak Detection Technologies For Challenging Drug Products

By Oliver Stauffer

PTI’s MicroCurrent HVLD has been hailed as a method that can leak test a wide range of product conductivities and chemical characteristics. This is extremely valuable for the pharmaceutical industry, by leveraging test method development on some products to validate other products. If a pharma site is producing 1 ml syringes, they may be filling them with a wide range of products. If PTI’s MicroCurrent HVLD is used to test the product, the system can be used to develop a method on low conductivity and high conductivity products. Once the two methods are developed and the parameters are shown to be universal across the two conductivities, the method can be leveraged to validate product formulations that reside within that range of conductivities. Doing so will save pharmaceutical companies valuable time and resources in deploying a test method.

The E-Scan 655 was recently tasked with testing an extremely challenging product in a pre-filled syringe. The product was highly viscous, something that any vacuum based method will have no chance of inspecting. It was determined that the product was not only viscous but had a very low conductivity. The extremely low conductivity combined with the molecular size of the product compounded the issues around conductivity. The molecule size and lack of ionic interaction made it even less able to transfer high voltage in the presence of a leak. The most challenging parenteral products are highly viscous, large molecule, and very low ionic interaction or conductivity. Using a series of uniquely designed HVLD scanning probes and the right combination of high voltage applied, the E-Scan 655 was capable of detecting the defects.