Using Parylene to Protect Medical Devices
Parylene’s ultra-thin, pinhole-free,biocompatibility and biostable benefits offer exceptional properties for medical device protection.
The issue of biostability and biocompatibility has been a critical concern for manufacturers of stents, cardiac devices, catheters, needles, medical implants, bone pins, prosthetic hardware, medical probes, and various implants and/or surgical components. These products must be chemically inert for the protection of both the device and the patient. Lack of biostability and/or biocompatibility in such materials, which come into direct and prolonged contact with body tissue, body fluids, electrolytes, proteins, enzymes, and so on, can result in serious medical consequences.
Parylene is a pure, crystal-clear, polycrystalline, and amorphous linear polymer that represents a viable option for medical coating applications because of its biocompatibility and biostability.
The Specialty Coating System’s medical coating team has played a vital role in assisting medical device manufacturers worldwide to assist them in developing advanced medical technologies. SCS maintains both drug and device master files with the FDA for the Parylene polymers. In addition, SCS assists manufactures in numerous ways, including providing ISO 14644 cleanrooms, Accredited Third Parties (USA), Notified Bodies (EU) coordination, USP Class VI polymer certification, 11 worldwide locations, ISO 9001:2008, AS9100C certified coating centers, and collaborations with global research and university facilities.
This information is available on request. SCS’s medical coating team can also provide data on body tissue and blood-compatibility studies carried out at the Battelle Memorial Institute, the University of North Carolina, Johns Hopkins Hospital, the University of California, Carnegie Mellon University, the University of Michigan, and other institutions.