Application note: In-process monitoring of headspace oxygen levels

Monitoring headspace oxygen to ensure stability and potency of finished oxygen sensitive product.

The need to monitor headspace oxygen levels in parenteral containers arises from the requirement to ensure the stability and potency of oxygen-sensitive product. This application note describes how headspace oxygen levels are monitored during the filling process as an in-process control (IPC) of the purging system used to bring headspace oxygen levels below a required specification. Non-destructive headspace oxygen analysis enables 100 percent (or statistical) inspection of finished product.