Protecting Diagnostics from Oxygen Damage
In the world of diagnostics and medical devices, precision and reliability are non-negotiable. While essential for life, oxygen is a highly reactive molecule that can degrade sensitive components, compromise sterility, and shorten shelf life. For medical device manufacturers, understanding and mitigating the impact of oxygen is critical to ensuring product performance, patient safety, and compliance.
Why Oxygen Matters
Oxygen can be a catalyst for a range of degradation processes. In diagnostic kits and medical devices, it can:
- Corrode metal components, weakening structural integrity.
- Degrade sensitive materials, like polymers, adhesives, and coatings.
- Support microbial growth, especially in combination with moisture.
- Compromise electronic components, particularly in devices with embedded sensors or circuits.
These effects are especially significant in high-risk applications like drug-coated stents, bone cements, and oxygen-sensitive diagnostic kits.
The Packaging Challenge
Most medical device packaging is porous by design, allowing for sterilisation processes like ethylene oxide gas exposure. However, this porosity can make it vulnerable to oxygen ingress. Even non-porous packaging can suffer from microleaks—tiny imperfections that allow oxygen to seep in over time, undermining the protective barrier and accelerating degradation.
Solutions: From Barriers to Predictive Tools
To combat oxygen-related risks, manufacturers are turning to a combination of material science and predictive modelling:
- Oxygen Scavengers and Desiccants
Oxygen scavenger products like PharmaKeep® and ADP® (Advanced Desiccant Polymer) solutions are designed to actively absorb oxygen and moisture within packaging environments. They are particularly effective in extending shelf life and maintaining sterility
- Barrier Packaging
Barrier bottles, such as OXYNOV® use multi-layer extrusion with ethylene vinyl alcohol to create high-resistance packaging. These containers are compatible with standard closures and can be paired with scavengers for enhanced protection
- Predictive Simulation Tools
To accelerate time-to-market and reduce the need for extensive stability trials, predictive simulation tools like Stablus® simulate oxygen and humidity levels inside packaging over time, helping manufacturers optimise packaging configurations before physical testing.
- Leak Detection and Integrity Testing
Test methods, such as those conforming to ASTM standards, are essential for identifying microleaks and ensuring container closure integrity. These tests provide quantitative data that support regulatory submissions and quality assurance.
Real-World Applications
In diagnostic applications—including, but not limited to, glucose strips, lateral flow tests, and microplate ELISA assays—oxygen control is vital. These products rely on biological reagents that are highly sensitive to oxidation. Packaging solutions tailored for these applications, including embedded desiccants and oxygen barriers, are standard practice throughout the industry.
Final Thoughts
By investing in advanced packaging technologies and predictive tools, manufacturers can safeguard their products from degradation, extend shelf life, and uphold the highest standards of patient care. If you're preparing for a product launch or looking to optimise your current packaging strategy, now is the time to evaluate your oxygen protection measures. The right solution could be the difference between a product that performs—and one that fails.
About Colorcon
Colorcon is a world leader in the development, supply and technical support of specialty excipients: formulated film coating systems, modified release technologies, and controlled atmosphere packaging. Our protective packaging advances shelf life, stability and efficacy across diagnostics, environmental testing and food and beverage quality control. From moisture-defense desiccants that support rapid testing to next-generation diagnostic packaging solutions, our proven solutions satisfy regulatory frameworks and specific use cases with ease.
PharmaKeep® is a registered trademark of Mitsubishi Gas Chemical Company.
