Ozon Generation During High Voltage Leak Detection. Fiction or Reality?

Abstract

In order to further clarify if and how much Ozone is generated during HVLD and to identify measures to reduce the impact of Ozone generation on product quality a highly sensitive analytical system [4] was employed to investigate the generation of Ozone at different operational conditions of HVLD integrity testing. The analytical system is based on oxidation of Iodide ions in solution and identification of the Iodine formed by N, N-Diethyl-p-phenylendiamine (DPD) according to DIN 38403 [4].Sensitivity of the system was found suitable to detect Ozone levels as low as 0.025 ppm (mg/l). HVLD process parameters inspection speed, high voltage, filling level of the ampoule and exposure time to the ampoule to high voltage were varied between maximum and minimum values ap-plicable in integrity testing of different ampoule sizes. For variation of exposure time ampoules were repetitively tested by the leak testing machine to acchive a maximum exposure time of the ampoule up to 24 sec (exposure time during production <=2,4 sec). No Ozone was detected during the study under all inspection conditions. Even repeated exposure of the ampoules to high voltage leak detection did not result in generation of measurable Ozone levels. It has to be concluded that high voltage leak detection is not prone to cause oxidation of the drug products.