There’s no margin for error in medical device manufacturing and assembly. The introduction of even the smallest of unwanted particles can cause a pacemaker to malfunction or introduce bacteria into a patient’s system. As a result, many of these products are made in dry and white rooms. These areas play a crucial role in creating safe, reliable products, as described below.

Dry Rooms

Moisture can enter electronic systems and cause serious problems with the components. It may also spur bacteria growth. Dry rooms maintain a vapor-tight barrier to reduce moisture in the air. They also have temperature and humidity control so these factors don’t harm instruments, impact the shelf-life of components, or compromise product sterility.

Even after the device is completed, heat and humidity can cause its parts to come apart or make it operate less effectively. This is why instructions for storage and use should also be clearly placed on the packaging. 

White Rooms

Nearly microscopic contaminants can compromise medical device manufacturing. Professionals reduce the likelihood with white rooms. These rooms are kept extremely clean with sterilization techniques; furthermore, any thing or person entering them is first cleaned and sterilized in an airlock. Walls and ceilings are sealed, and entering air is filtered. This ensures dust, bacteria, or other particles can’t taint the component parts. This will help your products meet the rigorous standards set by the FDA and ensure quality for the patients who will be making use of them.

Pacific Integrated Manufacturing in Bonita, CA, is well-known for its diagnostic and medical device manufacturing services. They handle everything from helping engineer the product to building and packaging it, with access to plastic injection molding and assembly kitting machines. Their reputation for the last 15 years has been one of professionalism, ensuring high-quality results every time. Visit their website to learn more about their company. Call (619) 921-3464 to speak with a representative.