Medical Device Quality Standards and Compressed Air Testing

Compressed Air has various applications in the medical device industry from coating application, to product transport, to equipment and merchandise cleaning. Because medical devices are put within the human body, the goods are especially high-risk. The human body is quite sensitive to invasive substances and it is the responsibility of producers to make sure the products which they supply are up to safety standards. Sanitation And cleanliness are the main facets of medical device manufacturing. Since compressed air is a crucial element in the production of medical devices, this applies to compressed air systems also. Contaminated compressed air can undermine the integrity of the medical device products and place consumers at risk. Compressed air must meet medical apparatus quality criteria and producers need to give validation that their air systems are clean, effective and pose no danger to customers.

Oil, Particulates, water vapor, and bioburden are especially dangerous compressed air pollutants that could affect medical devices. Oil-free air Is a critical in medical device and pharmaceutical production Adfolk, 2016. Cleanroom specifications require that no oil is present at Critical Control Points. Oil may cause some products to increase in size or experience a chemical imbalance. Oil-free air compressors and adequate filtration can help producers prevent and remove oil in the atmosphere. Particulate Contamination can impact the security of medical device products also. By way of instance, if metal shavings exist in the supply line and then affect the goods, this couldn’t just damage the physical appearance of the item but also place the consumer at risk. Compressed Air is often utilized to dry medical device products and if this air is contaminated with water vapor, the tools won’t fully dry. This may result in degradation of a number of products and become a breeding ground for extra contamination like microorganisms.

Bioburden Is especially dangerous and a contamination may threaten patient safety or lead to regulatory intervention. Compressed air systems which are improperly maintained or have insufficient materials can introduce germs, yeast, or mould into the end product. This sort of contamination puts consumers at a terrific risk. A medical Apparatus compressed air system should include a properly preserved compressor, decent piping and supply, and powerful filters. It is crucial to properly maintain the system, monitor closely for leaks, and change filters in accordance with the manufacturer’s recommendations. Contaminants can enter the system in an assortment of areas from the ingestion, to the piping, into a system flow. As a result of this, it is important to consider many points on the medical device testing. By way of instance, testing only at the breaker could allow for contamination down the line to go unnoticed. Tracking the air quality in an assortment of locations can help producers narrow down a pollution source and act effectively to fix it.