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PCT Parylene is USP Class VI Approved

We have documentation from an independent lab showing that our Parylene Type N has passed USP Class VI testing and meets the FDA guidelines for implantation. Also, our Parylene Type N is recognized and approved by the FDA as a biocompatible material.

What does USP Class VI mean?
“Class VI” means USP Plastic Class VI, one of six designations for plastics from General Chapter of the United States Pharmacopeia (USP) and National Formulary (USP-NF). A set of tests for determining basic safety are laid out, along with guidelines for how to test and how to certify a material to USP Plastic Class I-VI. The United States Pharmacopeia (USP), which is a non-government organization that endorses public health by establishing up to the minute standards to safeguard the quality of medicines and other health care technologies. This organization is concerned with the pharmaceutical and bio-technology industries.

Why is USP Class VI testing approval important?
Something that is listed as being USP Class VI demonstrates that the materials utilized are biologically compatible when tested according to the U.S. Pharmacopoeia XXII, 1190 Class VI, Plastics Evaluation. As defined in the U.S. Pharmacopoeia XXII, materials which pass the Class VI Plastic Evaluation are suitable as implantable materials.

The USP sets standards for quality, purity, strength and consistency. These USP Standards are published in the US Pharmacopeia and the National Formulary (USP NF). USP Class IV types of products go through a series of biological tests. The USP Class VI compounds must be made from ingredients with clear histories of biocompatibility that meet tight requirements for leachates.

The USP defines six plastics classes, from I to VI (VI being the most strict). Therefore, many plastics manufacturers find it advantageous to have their plastic resins certified as USP Class VI, especially if the resin is a likely candidate to be used in medical devices. A plastic resin material that has passed Class VI certification is assumed to be more likely to produce favorable biocompatibility results.

For a product to pass USP Class VI standards, it must exhibit a very low level of toxicity by passing all of the tests requirements. Compliance to USP Class VI is often requested by end users. Testing for compliance involves an assessment of the effects of the material, and extractables, on tissue.

USP Class testing designates that PCT’s Parylene N is safe for use in manufacturing medical devices.

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Para-Coat Technologies
17 Johns Street
Johnstown, PA 15901
Phone: (814) 254-4376
Fax: (814) 254-4057