USP CLASS VI Standard Test for Medical Molding and Biocompatible Rubber

EUROLAB laboratory provides testing and compliance services under the USP CLASS VI standard. USP Grade testing is one of the most common testing methods for determining the biocompatibility of materials. There are six classes, VI being the strictest.

Class VI tests aim to document the absence of harmful reactions or long-term bodily effects caused by chemicals leached from plastic materials. USP class testing standards are set by the United States Pharmacopeia and National Formulary (USP-NF), the organization responsible for the quality and safety of medical devices and foods.

Class tests are often performed on plastic materials that come into contact with injectable drugs and other liquids found in various steps of the drug manufacturing process.

The USP Class VI test is performed by producing an extract of the product with different extraction liquids such as polyethylene glycol and vegetable oil and injecting it in vivo (live) into the sample (rabbits and mice) to observe the biological response of the extract.

Grade testing is often required for drug manufacture due to low toxicity compatibility and stringent biocompatibility standards. It is important to know that no surface in contact with the fluid will release harmful chemicals into the fluid being conveyed.

Class VI testing thoroughly investigates the reaction in body, skin and living tissue to ensure safety. USP Class VI is a common standard for pharmaceutical vials, fittings, disposable systems, and fabricated parts.

EUROLAB assists manufacturers with USP CLASS VI test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.