USP Class 6 Spec Encapsulants and Adhesives

USP Class 6 Silicone Rubber Compounds

Several Momentive Performance Materials RTV silicone rubber compounds can be evaluated for USP Class 6 applications such as RTV108 and RTV118.

USP Class 6

USP Class testing is one of the most common methods of testing to determine bio-compatibility of materials. There are six classes, VI being the most rigorous. Class 6 testing is aimed to certify that there are no harmful reactions or long-term bodily effects caused by chemicals that leach out of plastic materials. USP Class Testing standards are determined by the United States Pharmacopeia and National Formulary (USP-NF), the organization responsible for the quality and safety of medical devices and foods. Class testing is frequently conducted on plastic materials that come in contact with injectable drugs and other fluids found in various steps of the drug manufacturing process.

Class testing is often required for manufacturing drugs for its low toxicity compliance and strict bio-compatibility standards. It is important to know that no fluid-contact surfaces will result in harmful chemicals being extracted in to a conveyed fluid. Class VI testing extensively investigates the reaction in the body, skin, and living tissue to ensure safety. USP Class VI is a common standard for pharmaceutical tubing, fittings, single-use systems, and fabricated parts.