The need to keep headspace oxygen levels under control in containers filled with sterile injectable drugs keeps up with oxygen-sensitive product stability and efficacy. Besides a reduction of drug potency and shelf life, the product degradation involves many other negative side effects.
Headspace oxygen levels are therefore to be maintained below the required specification.
- Quick feedback for optimal filling and primary packaging process operation; continuous monitoring and improvement of purge efficiency.
- Headspace oxygen monitoring can provide quantitative information on Container Closure Integrity by measuring oxygen ingress.
- It is the only alternative to destructive sampling of random samples from the production batches.