Application Note: Headspace Oxygen Measurement In Vials And Ampoules With The Orbisphere PharmaPack In The Pharmaceutical Industry

By Hach Ultra Analytics

Small volume parenteral (SVP) solutions are packaged in different ways depending on their intended use: as heat-sealed ampoules, vials sealed with a rubber closure, or prefilled syringes.

In some cases oxygen may have negative effects on the product such as:

• oxidative degradation of the active drug substance
• decrease drug potency and reduce product shelf life
• product discoloration, changes in dissolution rate and profile, precipitation
• generation of foul odors and flavors
• generation of adverse pharmacological properties, including those associated with toxicity or negative side effects