13 Facts about WILCOs Headspace Analysis Approach

Headspace Analysis (HSA) has emerged as one of the most advanced, non-destructive methods for Container Closure Integrity Testing (CCIT). At WILCO, we’ve pioneered HSA for over two decades, offering precise, scalable solutions trusted by global manufacturers.

Here are 13 essential facts about our HSA systems that demonstrate why they’re the benchmark in pharmaceutical inspection technology.

1. Precision at Scale: Less than 0.04% O₂ standard deviation

Our laser-based oxygen analysis achieves industry-leading precision with a standard deviation of under 0.04% O₂, even at line speeds of up to 320 vials per minute. This level of accuracy ensures robust and reliable CCIT without compromising throughput.

2. Proven Track Record Since 2003

WILCO introduced its first fully automated inline HSA system in 2003. Since then, we've continuously refined the technology making it faster, more accurate, more flexible, and compliant with evolving industry standards like USP <1207>.

3. O₂-HSA for Integrity & Microbial Detection

Our oxygen-based HSA systems are not just about detecting leaks. They’re also used to monitor potential microbial growth, making them valuable for media fill testing and sterility assurance. Additionally, Process Analytical Technology allows to determine the O₂ value for the determination of concentration for oxygen sensitive products. 

4. CO₂-HSA for Leak Detection & Bombing

CO₂-based HSA in combination with Wilco’s bombing technology allows leak detection down to 0.1µm. It enables reliable leak detection by identifying changes in carbon dioxide levels, 

5. H₂O-HSA for Freeze-Drying & Vacuum Verification

Designed for containers closed under vacuum, our water vapor HSA systems verify vacuum levels post-lyophilization. This is critical for ensuring long-term product stability in freeze-dried pharmaceuticals. Annex 1 requires testing if vacuum level is stable and guaranteed. 

6. Different Laser Integration for More Applications

WILCO integrates up to two different laser heads in lab as well as inline inspection solutions. As a result, customers benefit from greater flexibility, reduced equipment footprint, and future-proof investment by covering multiple inspection needs with a single, versatile platform.

7. Integrated PAT for Production Efficiency

HSA can be integrated as a Process Analytical Technology (PAT) tool within your production line. This allows real-time quality control, faster decision-making, and better overall batch consistency.

8. Residual O₂ Below 1%  -  Even During Filling

We enable measurement of residual oxygen levels below 1% directly in the filling line. This early insight helps optimize process conditions and reduce rework or rejection rates.

9. Sampling & Automated IPC for Vacuum Control

We offer flexible in-process control (IPC) solutions: From sample-based testing to fully automated systems to monitor vacuum levels in lyophilized vials. This ensures compliance without slowing down your process.

10. Scalable for Any Setup: Lab to High-Speed Lines

WILCO’s HSA modules are used in lab setups, semi-automatic systems, and fully automated lines, scaling up to 500 containers per minute. Whether you're in development or full-scale production, we’ve got you covered.

11. Multi-Modul Inspection for a holistic approach: Combine with Visual Inspection or NIR

For even more certainty, our HSA systems can be combined with automated visual inspection or NIR spectroscopy. This hybrid approach provides a deeper, more accurate assessment of container integrity.

12. Non-Destructive & Deterministic according to USP <1207>

HSA is a non-destructive and deterministic test method, aligning with USP <1207>. You can rely on repeatable, data-driven results (in compliance with 21 CFR part 11) without destroying a single sample.

13. More Than Just Vials: Ampoules, Syringes & Flex Packs

HSA isn’t limited to vials. Our systems are also compatible with ampoules, syringes, BFS containers and IV bags making them versatile for a wide range of primary packaging types in pharma and biotech.

WILCOs HSA systems represent the gold standard in container closure integrity testing. With unmatched precision, full scalability, and compliance with the latest regulatory frameworks, HSA gives pharmaceutical manufacturers the confidence to release safe, stable, and sterile products.