Oxygen headspace analyzer for container closure integrity testing
In pharmaceutical manufacturing and packaging, ensuring the integrity of sealed containers is crucial to maintain product quality. This involves monitoring oxygen levels to prevent degradation of oxygen-sensitive products, which can compromise their efficacy and safety.
Monitor headspace oxygen levels non-destructively
The FMS-Oxygen Headspace Analyzer by Lighthouse Instruments is a non-destructive tool designed for rapid analysis of headspace oxygen in sealed parenteral containers. The analyzer caters to the entire product lifecycle from development to QC laboratories, and at-line in-process control. It is useful for applications such as leak detection, container closure integrity testing, and monitoring gas purging processes. The measurement range covers 0 to 25% oxygen, customizable up to 100%. It can handle various container types including syringes, autoinjectors, ampoules, vials, and bottles, with sizes ranging from 6.85mm to 86mm in outer diameter. The system is compliant with 21 CFR Part 11 and Annex 11 requirements, ensuring adherence to regulatory standards.
Benefits
- Non-destructive analysis
- Applicable across entire product lifecycle
- Supports various container types and sizes
- Regulatory compliant software
- Customizable measurement range