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Parylene Coating in Medical Devices By David Pribish, General Manager, Para-Coat Technologies
stringent requirements. Fortunately, a coating has been around for the last 45 years, which meets or exceeds nearly all of these require- ments. Biocompatible and biostable, Para-Coat
T
Technologies’ (PCT) Parylene coatings pro- vide medical devices and components with ex- cellent moisture, chemical and dielectric pro- tection. When a material is biocompatible, it will not interact negatively with living tissue, is nontoxic and physiologically nonreactive.
FDA Approval The U.S. FDA has approved Parylene
with a Class IV biocompatibility rating suit- able for human implantable devices, based on its performance in the USP Class VI grade and ISO 10993 group of standards. It is trans- parent, pin hole free and is truly conformal, meaning that it will adhere to any shape or geometry. Parylene is applied using a vacuum dep-
osition process, which allows the coating thickness to be controlled and consistent. The application process also allows Parylene, which is a very small molecule, to provide deep crevice penetration and extremely thin coatings in comparison with other material. This type of coating is very desirable when added weight or volume to a device can cause it to fail. Parylene also has a coefficient of friction rele-
vant to PTFE (Teflon), which is excellent for appli- cations where lubricity is important. This dry lu- bricant is suitable for stents, syringes, catheters or any other device when increased friction leads to
he need for a biocompatible coating in the medical field has greatly increased. This demands a material that can meet all of the
longer and more painful procedures. Parylene is composed of long, chain-like polymers and is best known for its ability to recover its original shape after being stretched.
This is critical in a hospital setting, where it
is vital to keep instruments free of contamination. The addition of Parylene will also protect the coat- ed parts from chemicals, moisture and bodily flu- ids. Basically, Parylene will protect the device from the body and the body from the device, which helps extend the life of the product and prevent premature failure. With increasing technological develop-
Parylene coatings in medical devices protect both the device and the patient.
Traits that include high elasticity, impact re-
sistance and gas permeability have led to Parylene being the coating of choice on flexible medical parts and devices. This highly flexible coating re- sists contamination and discoloration on medical- grade silicones and rubbers, making it a strong choice for a wide array of medical applications.
Sterilization Parylene is one of the few coatings that can go
through sterilization after the application process. Parylene can withstand E-beam, gamma ray, EtO, H2O2 plasma and autoclave sterilization methods.
ments in the medical field, the need for a coat- ing material that can accommodate changing technology has become very important. The strongest choice is Parylene with favorable characteristics, such as biocompatibility, biostability, enhanced lubricity, high corro- sion resistance and wear resistance, chemical inertness and ability to withstand steriliza- tion. Having FDA approval, Class VI certifi- cation and meeting ISO 10993 standards, PCT’s Parylene is an excellent choice for a wide variety of medical devices, implants and elastomers. Para-Coat Technologies is a full-service
Parylene provider. The company offers purities greater than 99.9 percent. When dealing with
implantable devices that will be placed in the human body, the purity of the raw material is critical. The company recently added Cleanroom ISO
7 capabilities, as well. Medical applications in- clude: needles and probes; medical electronics; car- diac assist devices; mandrels and molds; elas- tomeric seals, gaskets and tubing; stents; and
cochlear and ocular implants. Contact: Para-Coat Technologies, Inc., 17
Johns Street, Johnstown, PA 15901 % 814-254-4376 fax: 814-254-4057 E-mail:
info@pctconformalcoating.com Web:
www.pctcc.com r
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