What is USP Class VI？

What is USP?

The United States Pharmacopeial Convention (USP) is a scientific organization focused on setting standards for healthcare, food ingredients, drugs, dietary supplements, and medical technology. Its purpose is to ensure safety and efficacy by ensuring ingredient accuracy, manufacturing process specifications, and stability of products

What is USP Class VI?
USP grade testing is one of the most commonly used testing methods to determine the biocompatibility of materials. It is divided into six levels, and the level testing standards are determined by the organizations responsible for medical device and food quality and safety, the United States Pharmacopeia and the National Formulary (USP-NF); VI is the strictest. The VI level test aims to demonstrate that there will be no harmful reactions or long-term physical effects caused by chemicals seeping out of plastic materials.
What are the USP Class VI testing methods?
The provisions of Chapter 88 of the United States Pharmacopeia and National Formulary (USP-NF) regarding USP Class VI involve in vivo biological reactivity testing, with the core objective of evaluating the biological effects of materials on live animals. This testing system includes three specific requirements. Including: acute systemic toxicity test, intradermal test, implant test.
Who would use products that have passed USP Class VI?
1. Medical and pharmaceutical industries
2. Manufacturers of biopharmaceutical process equipment
3. Materials for medical equipment used as components of pumps and fluid transmission systems
4. Disposable process components, pipes, disposable bags, plastic connectors, silicone

The materials that have passed USP Class VI certification include
TF1570 modified PTFE board
24SH expanded PTFE board
30SH high-quality expanded PTFE
28LS-LE expanded PTFE gasket with anti diffusion barrier, etc