Moisture And Oxygen Risk in the Medical Device Industry

The majority of medical device packaging is porous in nature. Some medical devices require a different layer of defense protecting against oxygen or moisture ingress. For some devices the ingress of moisture or oxygen over the shelf-life of the product can impact the device performance. Any time a foil barrier comes into play with a high-risk application, detection of microleaks is absolutely critical to assuring the shelf-life of the products.

Drug coated stents. Moisture sensitive bone cement. Oxygen critical diagnostic kits. Each application has a significant risk associated with microleaks impacting product performance over the shelf-life of the product. Ultimately the risk associated with package integrity failure is based on the impact of container system failure. While non-porous medical device packages often still require sterility, moisture and oxygen will be the first environmental contaminants to lead to product failure. Identifying moisture critical leaks at the point of manufacture and assuring proper secondary package transportation performance are two of the most beneficial steps one can take to guarantee product performance and patient safety.