Ozone Detection in Pharmaceutical Containers

Ozone Detection in Pharmaceutical Containers
Pharmaceutical vials are subjected to a high voltage leak detection (HVLD) test. A
high voltage (up to 30kV) is passed across the surface of the vial and the presence
of a crack is detected through a change in the current. HVLD has been linked to
the breakdown of active pharmaceutical ingredients (APIs) and it is hypothesised
that ozone, a strong oxidising agent, generated as a consequence of the high
voltage, is responsible. (1) It is crucial that the manufacturing process is designed
to minimise any changes to the molecular structure of biopharmaceuticals and
this extends to ensuring that container integrity testing does not cause product
degradation.