Parylene Coating Biocompatibility

Posted by Advanced Coating on Jul 27, 2022 8:21:04 AM

medical doctor in hallway

Several industries depend on parylene conformal coating to protect their devices, but the medical industry, in particular, relies on this coating for several reasons, such as smoothness, lightweight protection, and thinness of the coat. Parylene is also beneficial for medical applications due to its biocompatibility, meaning it does not cause bodily harm or negatively impact the skin.

Parylene Conformal Coating

Parylene is a conformal coating for medical devices such as surgical instruments, catheters, stents, or implants. It is used to protect the devices from environmental threats, chemicals, and bacteria. Parylene conformal coating has a protective layer that can resist water, bodily fluids, and acid. When creating the coating, parylene is deposited in vapor form, making it easy to coat and spread evenly across medical equipment. It’s for these reasons that parylene is the best choice for conformal coating.

How Parylene Coating is Biocompatible

Conformal coating must meet guidelines for cleanliness, reliability, and consistency when using it for medical applications. For patient safety and protection, the FDA requires that the devices have an antimicrobial and hypoallergenic coating so they don’t cause inflammation or irritation to the skin and organs. When a foreign object is inserted into the body, there could be a high risk of infection or exposure to bacteria. Therefore, the coating needs to be biocompatible. 

Here are four ways that parylene is biocompatible:

1. Non-Toxic and Chemically Stable

Parylene conformal coating is non-toxic to the skin and is compatible with cell growth and blood coagulation. It is chemically inert, meaning that the coating will not react to other chemicals in the body and vice versa. 

2. Low Friction

Parylene is a low-friction polymer, which means it allows for smooth sliding and can serve as a dry lubricant. If the device has high friction, it causes pain in the body, and therefore, it can negatively impact a procedure. 

3. Fungus Resistant

Parylene is resistant to the growth of fungi, bacteria, and microbes. Even while the coating has that protection, parylene-coated medical devices can also be sterilized safely to remove all organisms before being used on a patient.

4. Meets USP Class VI Standards

Parylene meets the United States Pharmacopeia’s (USP) Class VI and ISO 10993 standards for biocompatibility, which means it has a proven track record of safety and reliability for the medical industry.

Parylene conformal coating is not only essential for protecting the devices but also for the patient’s health. It can protect against even the most extreme conditions in the body. Additionally, parylene is a stable coating that is free of pinholes, which can prevent any accidental exposure to the device leading to contaminating the patient.

If you would like to know more about the safety and use of parylene conformal coating, contact us today or request a quote!

Topics: Parylene Conformal Coating