Compressed air has a variety of uses in the medical device industry from coating application, to product transfer, to equipment and product cleaning. Because medical devices are placed inside the human body, the products are particularly high-risk. The human body is very sensitive to invasive materials and it is the responsibility of manufacturers to ensure the products that they provide are up to safety standards.
Sanitation and cleanliness are the most important aspects of medical device manufacturing. Since compressed air is a critical factor in the manufacturing of medical devices, this applies to compressed air systems as well. Contaminated compressed air can compromise the integrity of the medical device products and put consumers at risk. Compressed air must meet medical device quality standards and manufacturers have to provide validation that their air systems are clean, effective and pose no risk to consumers.
Oil, particulates, water vapor, and bioburden are particularly dangerous compressed air contaminants that can affect medical devices.
Oil-free air is a critical in medical device and pharmaceutical manufacturing (Arfalk, 2016). Cleanroom specifications require that no oil is present at Critical Control Points. Oil can cause some products to increase in size or experience a chemical imbalance (Nortec, 2018). Oil-free air compressors and adequate filtration can help manufacturers prevent and remove oil from the air.
Particulate contamination can affect the safety of medical device products as well. For example, if metal shavings are present in the distribution line and then impact the products, this could not only harm the physical appearance of the product but also put the consumer in danger.
Compressed air is often used to dry medical device products and if that air is contaminated with water vapor, the instruments will not completely dry (Chobin, 2017). This can cause degradation of some products and become a breeding ground for additional contamination like microorganisms.
Bioburden is particularly dangerous and a contamination can threaten patient safety or lead to regulatory intervention. Compressed air systems that are improperly maintained or have inadequate materials can introduce bacteria, yeast, or mold to the end product. This type of contamination puts consumers at a great risk.