In-Process Controls Of Pharmaceutical Headspace Analyzers

Many of today’s parenteral drugs exhibit some degree of oxygen sensitivity. Isolators and improved purging systems on filling lines enable the filling of product under an inert gas such as nitrogen. It is therefore desirable to effectively control and monitor headspace oxygen levels during the filling process.

Conventional electrochemical methods used for headspace oxygen analysis in parenteral containers are time consuming, resource intensive, operator dependent, and have high running costs due to the use of consumables and the disposal of destroyed product.

There is a trend to replace electrochemical headspace oxygen analysis methods with rapid non-destructive headspace inspection platforms from LIGHTHOUSE. The benefits include faster feedback on purge performance during filling, no waste disposal of destroyed product, and a greater confidence in the oxygen levels measured.

In QC the rapid measurement techniques allows for quick and efficient stability studies. The nondestructive nature of the measurement saves QC product samples that may be in limited supply and allows for the accurate monitoring of the oxidation of a single sample over time.